CELEX: 51998PC0180
Language: en
Date: 1998-03-30
Title: Proposal for a Council Decision on the conclusion of an Agreement on mutual recognition in relation to conformity assessments, between the European Community and the United States of America

COMMISSION OF THE EUROPEAN COMMUNITIES
                                             Brussels, 30.03.1998
                                             COM(1998) 180 final
                                             98/0105 (ACQ
                              Proposal for a
                         COUNCIL DECISION
on the conclusion of an Agreement on Mutual Recognition in relation to
                   Conformity Assessments, between
      the European Community and the United States of America
                     (presented by the Commission)
 ---pagebreak---  ---pagebreak---                           EXPLANATORY MEMORANDUM
I. The Agreement
On the basis of the negotiating directives issued by the Council on 21.9.92. the European
Commission has negotiated and initialled an Agreement on the mutual recognition of
conformity assessment (Mutual Recognition Agreement, or MRA) with the US. A Text
of the Agreement initialled in June 1997 is annexed.
This memorandum provides an assessment of the Agreement in the light of the
negotiating directives approved by the Council, and recommends that the Council decides
to approve the Agreement by means of a Council decision to that effect.
LI Assessment of the Agreement
The Commission considers that the initialled Agreement, is in conformity with the
Council's negotiating directives, takes account of the views expressed by the 113 MRA
Committee, which gave detailed advice to the Commission during the negotiations, and
provides benefits to the European Community. The Agreement does not contain a rule of
origin. As for Canada this proved to be non-negotiable with the United States.
Member States are in the process of designating a considerable number of conformity
assessment bodies (CABs). Once these bodies have been provisionally accepted by the
United States, subject to formal acceptance by decision of the Joint Committee, the
Council Secretariat will receive this list of CABs by way of a Commission Staff paper.
Sufficient confidence exists between the Parties to the Agreement to allow them to
proceed.
1.1.1 Framework Agreement
The Agreement consists of a framework agreement and a series of sectoral annexes. An
article-by-article assessment of the framework follows:
Pre-amble : this sets out the basic objectives of mutual recognition agreements in terms
of trade facilitation.
Article 1: Definitions: these are self-explanatory.
                                               no                                  _
 ---pagebreak--- Article 2: Purpose: this article lays down the objective of the Agreement, i.e. effective
market access through the recognition of results of conformity assessments. It provides
the basis for terminating the Agreement, should market access be denied.
Article 3: General Obligations: this article sets out the obligation of each Party to
accept the results of conformity assessments carried out to its requirements by the other
Party, according to the terms of the sectoral annexes. Notably, the provision establishes
acceptance of product certifications and authorisations of each Party. This Article also
establishes the link between the basic obligations of the Agreement and. its sectoral
annexes.
Article 4: General Coverage: this article provides that the conformity assessment
procedures to which the Agreement applies are specified in the individual sectoral
annexes, and describes the content of the annexes.
Article 5: Transitional Arrangements: this Article refers to the transitional
arrangements set out in the annex, to the necessity of a time period for completion and
the possibility of amending it, and the need to move to full implementation by the end of
the period unless there is documentary evidence that the conditions for a successful
transition are not met.
Article 6: Designating Authorities: this is a key provision requiring designating
authorities to have the necessary formal powers over the bodies they designate. This
article thus provides a guarantee that US has the necessary authority to designate, suspend
or withdraw bodies.
Article 7: Designating and Listing Procedures: this article refers to the procedures
which apply for the designation of conformity assessment bodies, the way additional
bodies should be proposed, the time period for accepting or rejecting new designations
and the role of the Joint Committee in this respect.
Article 8: Suspension of Listed Conformity Assessment Bodies: this article establishes
the right for one Party to challenge the compliance of bodies in the other Party.
Verification will be carried out by the Party in whose territory the CAB is located. The
CAB will be suspended where disagreement over its status has been confirmed by the
Joint Committee, unless otherwise decided by that Committee. As advised by the
Member States in the 113 Committee MRA Group, the right of verification has been
closely circumscribed to prevent it being carried out routinely or unilaterally.
Article 9: Withdrawal of Listed Conformity Assessment Bodies: this article
establishes a detailed procedure and timing for the withdrawal of conformity assessment
bodies, including on the continued acceptance of the results of conformity assessments
carried out before their withdrawal.
Article 10: Monitoring of Conformity Assessment Bodies: this article contains a
commitment, from designating authorities, to ensure the continued capability of
conformity assessment bodies to assess products or processes.
Article 11: Conformity Assessment Bodies (CABs): this article states that CABs listed
in the Agreement are deemed fulfilling their conditions of eligibility for the listed
assessment procedures.
                                                 03
 ---pagebreak--- Article 12: Exchange of Information: a basic transparency provision.
Article 13: Sectoral Contact Point: this provides for the designation of contact points to
be responsible for activities under each sectoral annex.
Article 14: Joint Committee: this article requires the establishment of a Joint
Committee to administer the Agreement on behalf of the Parties. Duties of the Joint
Committee include designation of Joint Sectoral Committees and the adoption of voting
systems. It includes the procedure for formally adopting changes to the Sectoral annexes
to add or remove conformity assessment bodies, and discussing divergence of view. New
conformity assessment procedures applying to covered products will be brought within
the scope of the Agreement so as to preserve negotiated market access benefits. This
article does not give the Joint Committee the right to extend the scope and coverage of
the agreement to include new sectors. This has to be mandated by the Parties.
Article 15: Preservation of Regulatory Authority: this article confirms that the
Agreement has no effect on each party determining its own level of protection for human,
animal and plant life or health. It provides for a safeguard clause allowing each Party to
take urgent measures providing they inform their counterpart authority within fifteen days
and give the reason for.
Article 16: Suspension of recognition obligations: is a key provision authorising each
Party to suspend its obligations in case of loss of market access or failure, by the other
Party, to maintain authorities capable of implementing the provisions of the Agreement.
Article 17: Confidentiality: this article, debated at length, leaves to the legislation of the
importing .Party to determine the extent of confidentiality of information transmitted.
Trade secrets, confidential commercial or financial information and information relating
to ongoing investigation may not be disclosed to the public. It leaves to the exporting
party the right to designate the portions of information that should be exempt from
disclosure.
Article 18: Fees: this provides that a Party shall not charge fees for conformity
assessments carried out by other Parties in accordance with the Agreement and that any
fees charged will be commensurate with the services provided.
Article 19: Agreements with other countries: this article provides that any Mutual
Recognition Agreement between a Party to this Agreement and other countries shall have
no force in regard to the other Party to this Agreement.
Article 20: Territorial application: this article confirms that the Agreement applies
only to the territories of the European Community and the US.
Article 21: Entry into force, amendment and termination: this article lists all sectors
covered in the current Agreement and states that the Agreement will enter into force on
the first day of the second month following the exchange of letters confirming the
signature of the Agreement, that additional annexes, if any, will enter into force 30 days
after the relevant exchange of letters, and that the Agreement may be terminated by
giving the other party six month notice. With Article 16, this article contains a key
                                                  04                                         _
 ---pagebreak---  provision on termination of the entire Agreement in case there is no agreement on the
 termination of a certain annex.
 Articles 22: Final provisions: these are standard institutional and legal provisions. It
 should be noted that the Agreement is of unlimited duration.
 1.1.2 The Sectoral Annexes
There follows an assessment of the content of each sectoral annex in terms of its
coverage, the type of mutual recognition arrangements envisaged for the sector, and the
trade and other implications. In making this assessment, the Commission has kept in
mind the following elements:
a)      whether the sectoral annex provides for genuine mutual recognition, i.e. whether all
        relevant conformity assessment procedures for a particular sector have been
        captured;
b)      the level of trade between the Community and US for the sectors and products
        covered;
c)      the views expressed by Member States and European industry groups on the
        benefits of mutual recognition;
d)      the precedential nature (if any) of arriving at a mutual recognition agreement with
        US in the sectors covered;
e)      overall consistency with Community policy objectives in the field of
       standardisation, certification, designation of Conformity Assessment Bodies and
       the removal of technical barriers to trade.
The sectoral assessment is followed by an overall appreciation of the benefits of the
Agreement.
The Commission draws Member States' attention to the trade figures for each covered
sector in the Annex to this note. These figures show that for every sector concerned, with
the exception of medicinal products, the US have a small trade surplus with the
Community. Third party certification (the subject of the MRA) applies most commonly
to industrial products at the higher end of technology, in respect of which both the
Community and US are major exporters. A priori, this may indicate that the trade
facilitation benefits of the Mutual Recognition should accrue to both the Community and
the US. We note however, that trade flows only give a partial picture of the likely
benefits. The balance of benefits depends on additional factors, in particular the
following:
a)     the range of products within a sector subject to third party certification. Obviously,
       if in a given sector one Party has more comprehensive certification requirements,
       the trade facilitation benefits to the other i.e. exporting Party may be
       proportionately greater. In this respect, the tendency for deregulation seems to be
       more important in the EU and manufacturers' declarations of conformity are more
       used in the EU (e.g. for electrical safety, recreational crafts);
                                                      05
 ---pagebreak--- b)     the complexity and accessibility of the conformity assessment requirements of each
       Party, including the extent to which each Party applies internationally recognised
       standards or technical requirements for the sector in question. This may be an issue
       in various sectors in the case of US which have a fair number of non internationally
       harmonised standards and requirements.
The Commission notes that industrial groups consulted throughout the negotiations (such
 as EUROBIT, ORGALIME, EFPIA), while supporting the agreements, have not been
 able to quantify the costs or time taken by conformity assessment of an entire class of
products at import in the US or in the EU. It is therefore not feasible in every case to
determine the extent of savings in time, cost or market opportunity of the arrangements
set out in this Agreement. This may only be possible once the Agreement has been in
 operation for some time. What can be ascertained however is whether we have addressed
industry's concern that this Agreement provides reciprocal levels of market access, in
terms of conformity assessment procedures.
The Agreement also presents important advantages from the point of transparency,
market access, avoidance of duplication especially of cost, and general facilitation of
trade. This is of particular importance for small and medium sized companies.
On the basis of a rough calculation it is estimated that this Agreement will create cost
savings for the exporting industry of at least 190 MECU and an equivalent amount in
terms of cost savings to exporters to the EU, some part of which will be passed on to
European importers or consumers.
Where relevant, the above factors are taken into account in the assessment of each
sectoral annex.
Telecommunication Equipment
This annex concerns all telecommunications terminal equipment (TTE) regulated under
the relevant Community Directives, as well as non-harmonised Member
States'legislation for analogue connection to public networks and radiotransmitters for
civilian applications, and the corresponding US legislation. Both sectoral annexes on
electrical safety and electromagnetic compatibility apply also to the products covered by
this annex.
Through the Agreement, the regulatory authorities of the parties recognise the conformity
assessment certificates and test reports issued by the Conformity Assessment Bodies to
be listed in Section V. The Conformity Assessment Bodies will be required to comply
with the criteria and standards set out in the regulatory requirements of the other Party
(set out in Section VI). A list of Designating Authorities is given in Section IV. A Joint
Sectoral Committee is set up to discuss technical, conformity assessment and technology
issues relating to this annex and the one on electromagnetic compatibility.
The annex provides for a transitional period of 24 months to build confidence in and
understanding of each other's system for designating and listing CABs and in the ability
of these bodies to test and certify products. It provides for the reciprocal recognition of
test reports issued by designated CABs during the transitional period under certain
conditions. This transitional period will also be used to consider legislative changes
needed and initiate them to support the objectives of the agreement. There is a provision
for the organisation of two seminars, during the first year of operation of the transition
                                                  06                                      «
 ---pagebreak--- arrangements, on technical and product approval requirements. At the end of the
transitional period the Parties will grant full mutual recognition of compliance
certificates.
European industry organisations have been consulted extensively on the MRA
negotiations and have supported the approach, namely the logic built in between this
annex and the annex on electrical safety, i.e. that this annex would only operate once
enough CABs have been accepted for recognition. This provision ensures indeed a
balanced access to both markets. The agreement does provide for reciprocal recognition
of all conformity assessment procedures including final certification without further
product assessment by the importing party.
Electrical Safety
This annex covers the testing and certification requirements set out in the EC's Low
Voltage Directive and corresponding US regulations, including medical devices,
 telecommunication equipment and their electromagnetic compatibility aspects, and
except products certified or approved under the Federal Mine Safety and Health Act.
 A Joint Sectoral Committee is set up by section VII, with OSHA representing the US.
 Sections IV and V of the annex list the authorities responsible for designating the CABs
 and the CABs themselves (an initial list of CABs has to be included when the agreement
 is implemented). Section VI describes the procedures for designating and suspending the
 CABs. OSHA (Occupational and Safety Health Administration) will validate within 30
 days application dossiers and confirm CABs in Section V within 120 days. OSHA will
 rely on the EC designating Authorities for conducting on-site reviews at the respective
 Member States' CABs. This is a major improvement vis-à-vis the current situation.
 OSHA also agreed to consider regulatory and legislative changes needed to support the
 objective of an MRA.
 European industry groups have been consulted on the proposed MRA and have expressed
 support provided that we ensure that any agreement provides for reciprocity of market
 access and does not lead to the introduction of new and more onerous requirements.
 Given the existing openness of the EC regime, and the fact that the necessary US
 legislation is covered under the sectoral annex, these requirements have clearly been met.
 While manufacturers' self certification exists in the EC, third party certification is
 required for certain categories of products in the US and there are therefore clear
 advantages in the Agreement from an EC perspective.
 Electromagnetic Compatibility (EMC)
 In view of the "horizontal" application of EMC requirements to a wide range of electrical,
 machinery and telecommunications products, coverage of the EMC phenomenon in the
 MRA is necessary to achieve the objective of covering all relevant conformity assessment
 procedures.
 Each Party agrees to recognise the other Party's results of the conformity assessment
 procedures carried out by the CABs listed in section V of the annex, as required under
  their respective legislation, without any further assessment of the products.
 The Agreement also provides for a transitional arrangement of 24 months. During this
  period the Parties will work together to ensure familiarity with each other's regulatory
                                                        07                                •
 ---pagebreak--- requirements, exchange information and review the work carried out by designated
Conformity Assessment Bodies and demonstrate to each other's satisfaction their
capability to carry out conformity assessment to the requirements of the other Party.
During the first year of operation of the agreement,, the parties may jointly sponsor two
seminars on the relevant technical and product approval requirements.
Recreational Craft
The sectoral annex for recreational craft applies to all recreational craft, including
personal watercraft, which are subject to third party certification in the European
Community or US. The Agreement covers all relevant legislation (Directive 94/25) and
the Federal regulations in US. Both sectoral annexes on electrical safety and
electromagnetic compatibility apply also to the products covered by this annex.
The Parties will recognise certificates issued by each other's designated Conformity
Assessment Bodies without any further assessment of the products to which they relate.
A list of Designating Authorities is given in Section 3. The Conformity Assessment
Bodies will be required to comply with the criteria and standards set out in the regulatory
requirements of the other Party (set out in Section 4). The Conformity Assessment Bodies
are to be listed in Section 5.
The annex provides for a transitional arrangement of 18 months in which the Parties will
cooperate to establish a system for designating CABs and build confidence in the ability
of these bodies. During this period, they will exchange information on technical data and
conformity assessment procedures, developing greater familiarity with their respective
regulatory requirements, and carry out the legislative and regulatory changes necessary
for the provisions of their annex. During this period, the parties shall endeavour to
sponsor seminars for the purpose of improving the understanding of the respective
technical requirements.
Pharmaceuticals Good Manufacturing Practice (GMP)
This annex establishes mutual recognition of each Party's inspections of pharmaceutical
sites according to the GMP standards of each, which, subject to further verification
during the transition phase, have been declared '"equivalent" by the Steering Committee
of the International Conference on Harmonisation.
Recognition of inspection results is not automatic. Inspection reports will have to be
transmitted and "normally endorsed" by the importing party except under specific and
delineated circumstances. Endorsement of each other's inspection reports should remove
the need for companies in each Party to be inspected by the authorities of the other Party.
The products traded need no further batch.testing and control upon import, except for
biologicals, when an official batch release procedure applies (also called lot-by-lot
 testing); in this case, controls are carried out by the authorities.
The scope of the annex covers all medicinal products regulated by both parties, except
veterinary biologicals, which are regulated by a different US Agency (APHIS). A
separate annex to the agreement is being negotiated for these products. Human plasma
derivatives, investigational medicinal products, radiopharmaceuticals and medicinal
gases are not included in the transitional arrangements and their situation will be
                                                       08
 ---pagebreak---  reconsidered at the end of the transition phase. An indicative list of such products is also
 included (appendix 3 of sectoral annex).
 This annex applies only to pharmaceutical products subject to GMP in either Party. This
 permits inspections to be carried out against each Party's domestic GMP standard in most
 cases.
 The annex lists the applicable legislation and relevant certifying authorities. It also sets
 out in appendices 4 and 5 to the sectoral annex, the criteria for assessing equivalence of
 post- and pre-approval inspections and the elements to be considered in developing an
 alert system. It sets up a Joint Sectoral Committee.
 A three-year transition period is aimed at determining the equivalence of the "regulatory
 systems". All authorities are requested to actively participate in the determination of
 equivalence exercises in order to build a sufficient body of evidence for their equivalence
 determination.
 At the beginning of the transition period, the parties will exchange their draft
 programmes. Their implementation will permit the determination of the capacity of each
Party's authority to perform GMP inspections and ensure the appropriate enforcement.
At the end of this period, a list of authorities deemed equivalent will be agreed by the
Joint Sectoral Committee and any insufficient evidence of equivalence, lack of
 opportunity to assess equivalence or determination of non-equivalence will have to be
documented in sufficient detail.
European industry and Member States' inspection authorities (Working Group on
Inspection and control of medicinal products, and the Pharmaceutical Committee) have
been consulted at every step of the negotiation and support the arrangements negotiated.
This agreement provides mutual benefits to pharmaceutical companies, and some savings
to inspection authorities. The present agreement also establishes mechanisms for longer-
term cooperation between respective inspection authorities which will not only ensure the
agreement continues to be properly applied, but will stimulate further harmonisation
initiatives. The Community and the US are important trade partners in this sector and
trade is well balanced (see Annex 4) as well as the benefits expected from the Agreement.
Medical Devices
This annex establishes mutual recognition of the results of quality-system-related
evaluations and inspections and pre-market evaluations as conducted by listed conformity
assessment bodies (CABs); it provides also for other related co-operative activities such
as an exchange of post-market vigilance reports with regards to all products regulated
under both US and EC legislation.
This recognition is not automatic. Various types of reports will have to be transmitted;
they will be "normally endorsed" by the importing party, except under specific and
delineated circumstances. Endorsement of each other's reports should remove the need
for companies in each Party to be inspected and their application files be re-assessed by
the authorities of the other Party.
                                                     09
 ---pagebreak---  Product coverage, within the two Community Directives for medical devices, and for US
 their domestic legislation in this field, is determined in the annexes of the agreement and
 varies according to the nature of the evaluation and the phase of the agreement. For
 quality systems evaluations, the agreement covers all products regulated under both EU
 and US legislation. For products evaluations (product approvals), the scope is limited to
 those products classified under the US system as Class I/Class II - Tier 2 which are listed
 in Appendix 2 of the sectoral annex. The annex thus covers all conformity assessment
 procedures in the Parties, including final certification and approval for the products listed
 in the agreement.
 The annex provides for a transition period (3 years) which will evaluate the capabilities
 of the proposed Conformity Assessment Bodies. Conformity Assessment Bodies willing
 to participate in the confidence-building activities and meeting the criteria for technical
 competence and independence will be designated by each party and listed in Appendix 4.
 At the end of the transition period, the CABs will be jointly confirmed in an Appendix 5.
 Any "non-confirmation" of a proposed CAB would have to be justified based on
 documented evidence.
 A Joint Sectoral Committee is set up and at the beginning of the transition period, it will
 establish a joint confidence building programme including seminars, workshops, joint
 training exercises, observed inspections and the design of an appropriate system of
 exchange of information. The Parties will, during the transition, work to harmonise the
necessary information which must be present in quality systems, and product evaluation
 reports; they will also develop a notification and alert system. An annual report will
 describe the progress of the exercise. Harmonisation activities will include participation
in the Global Harmonisation Task Force and the utilisation of its results.
The requirements of third party premarket assessment are extensive on both sides and
cover up to 90% of the field. In this respect therefore we consider that the agreement
presents a balance of advantages to both parties.
In the light of the above, we believe European industry is content with the proposed
MRA in this sector. It is worth mentioning that the US Senate Committee on Labor and
Human resources recently stated that the MRA "will lay a flagstone in the path being
built toward harmonization activities on things like increase reliance on international
standards". The Commission considers that the MRA in this sector sets the right
precedents in terms of our long term objectives. All certification procedures are covered
and the product coverage will extend with time.
1.1.3 Relations with EFTA States, members of the European Economic Area
In accordance with the general information and consultation procedures set out in the
EEA Agreement and Protocol 12 of the said Agreement, the Commission has kept EFTA
/ EEA States regularly informed about developments in the negotiations and has informed
them on the final result of the negotiations.
The EFTA / EEA States have had preliminary talks with the US for negotiating a mutual
recognition agreement equivalent to the one to be concluded between the Community and
the US.
                                                      10
 ---pagebreak---    1.1.4 Overall Appreciation
  The Commission considers that the proposed MRAs create an acceptable balance of
  benefits for all parties overall, when all sectors are taken together. The overall trade
  balance with the US and the nature of the current certification procedures in the US
  would also suggest that the Agreement will bring a number of improvements for EC
  exporters. In all sectors the Community has secured effective market access - in terms of
  access to all mandatory procedures of the other party. US has accepted the Community's
  approach of reciprocally recognising not only testing, but also certificates and approvals
  of conformity to the other's requirements. The agreement will allow Community
  exporters, if they so choose, to test and certify their products to US requirements prior to
  export, and then access those markets without any further conformity assessment
  requirements. This will facilitate Community exports. European industry federations
  have been consulted on the Agreement and have supported it.
  The Commission has received indications that a large number of EC conformity
  assessment bodies would be interested to work in the framework of this Agreement, and
  this indicates both their technical capacity and economic interest in the Agreement.
 In several sectors the Agreement caters for the further development of the parties'
 regulatory regimes, with the aim of ensuring that future rules do not undermine the
 benefits of the agreement. And in several sectors, the agreement will help to promote
 wider acceptance of the Community's regulatory approach and technical requirements.
 II. Proposal for a Council Decision
 A proposal for a Council decision on the conclusion of the Agreement is attached. The
 decision has two objectives:
 a) to approve, on the basis of Articles 113 and 228 of the Treaty, the draft Agreement;
 and
 b) to establish the appropriate Community procedure to enable the Commission, assisted
 by the 113 Committee (Technical Group on Mutual Recognition), to represent the
 Community in the Joint Committee and the Joint Sectoral Committees established by the
 Sectoral Annexes and that the Community position in that Joint Committee and in the
 Joint Sectoral Committees in case of changes to the Annexes and other sectoral questions
 be determined in conformity with Article 228, paragraph 4 of the Treaty, by the
Commission in consultation with the 113 Committee.
 On this second aspect, it is noted that in Article 14 of the Agreement, a Joint Committee
of the Parties operates. This Joint Committee is responsible for the management of the
Agreement and has the delegated power to amend existing sectoral annexes. Suchrightof
amendment is restricted only to procedural issues concerned with implementation,
essentially: amending the references to the regulations applicable to covered sectors;
amending the annexes further to decisions to recognise, suspend, remove, or alter the
scope of activity of conformity assessment bodies or designating authorities in the
Agreement. The power to amend the framework agreement, to delete sectoral annexes or
to add new sectoral annexes rests with the Parties.
It is accordingly proposed that:
                                                        11                                «
 ---pagebreak--- a) the Commission, assisted by the 113 Committee (Technical Group on Mutual
Recognition) should represent the Community in the Joint Committee and in the Joint
Sectoral Committees established by the Sectoral Annexes, and that the Community
position in that Joint Committee and in the Joint Sectoral Committees in case of changes
to the annexes and other sectoral questions be determined, in conformity with Article
228, paragraph 4 of the Treaty, by the Commission following consultation of the above
mentioned committee.
b) for all other issues, the Community position shall be determined by the Council, acting
by qualified majority on a proposal from the Commission.
The Commission therefore proposes that the Council adopts the appended decision, and
indicates the person who, on behalf of the Community, signs the Agreement.
                                           I&
 ---pagebreak---                                  Proposai for a Council Decision
        on the conclusion of an Agreement on Mutual Recognition in relation to
                                Conformity Assessments, between
               the European Community and the United States of America
                                              (.../.../EC)
 The Council of the European Union,
 Having regard to the Treaty establishing the European Community, and in particular
 Article 113 in conjunction with Article 228, paragraph (2), (3) first paragraph and (4)
 thereof,
 Having regard to the proposal of the Commission,
 Whereas the Agreement on Mutual Recognition in relation to Conformity Assessment,
 between the European Community and the US, initialled in Brussels on 20 June 1997,
 has been negotiated and should be approved,
Whereas certain tasks for implementation have been attributed to the Joint Committee
 established by the Agreement, and in particular the power to amend the Sectoral Annexes
thereto;
Whereas the appropriate internal procedures should be established to ensure the good
functioning of the Agreement, and whereas it is therefore necessary to delegate to the
Commission the power to proceed to certain technical amendments of the Agreement and
to take certain decisions for its implementation,
Decides:
                                              Article 1
The Agreement on Mutual Recognition in relation to Conformity Assessment between
the European Community and US, including its Annexes are hereby approved on behalf
of the European Community.
The text of the Agreement and the Annexes are attached to this Decision.
                                              Article 2
The President of the Council shall, on behalf of the Community, transmit the letter
provided for in Article 21 of the Agreement1
1
     The date of the entry into force of the Agreement will be published in the Official Journal of the
    European Communities.
                                             d3                                                      #
 ---pagebreak---                                          Article 3
1.   The Commission shall represent the Community in the Joint Committee provided
     for in Article 14 of the Agreement, and in the Joint Sectoral Committees
     established by the Sectoral Annexes, assisted by the special committee established
     under Article 113 of the EC Treaty (Mutual Recognition). The Commission shall
     proceed, after consultation with this committee, to the appointments, notifications,
     exchange of information and the requests for verifications referred to in Article 10,
     letter b), 12, 13 and 14 paragraph 2 of the Agreement and the equivalent provisions
     of its Sectoral Annexes.
2.   The position of the Community in regard of decisions to be taken by the Joint
     Committee or if appropriate in the Joint Sectoral Committees shall be determined,
     with regard to amendments of the Sectoral Annexes (Article 14, paragraph 4, letter
     b), and Articles 7, 8 and 9 of the Agreement and the equivalent provisions of its
     Sectoral Annexes, and verification of compliance in accordance with Article 7 d) of
     the Agreement by the Commission, following consultation of the above mentioned
     special committee.
3.   In all other cases the position of the Community for a decision in the Joint
     Committee or Joint Sectoral Committees shall be determined by the Council, acting
     by qualified majority on a proposal from the Commission. The same procedure
     shall apply to decisions taken by the EC in the framework of Articles 16 and 21.
Done at Brussels,                                          For the Council
                                                           The President
                                                 14
 ---pagebreak---         AGREEMENT ON MUTUAL RECOGNITION
   BETWEEN THE UNITED STATES OF AMERICA AND
                THE EUROPEAN COMMUNITY
                   TABLE OF CONTENTS
               •»
1.  Framework                                   Page 1
2.  Telecommunication Equipment                 Page 15
3.  Electromagnetic Compatibility (EMC)        Page 29
4.  Electrical Safety                          Page 39
5.  Recreational Craft                         Page 49
6.  Pharmaceutical Good Manufacturing
    Practice (GMP)                              Page 55
7.  Medical Devices                             Page 71-113
                                15      Initialled on 20 June 1997
 ---pagebreak---             AGREEMENT ON MUTUAL RECOGNITION
      BETWEEN THE UNITED STATES OF AMERICA AND
                      THE EUROPEAN COMMUNITY
The Government of the United States ofAmerica and the European Community,
hereinafter referred to as "the Parties ",
Considering the traditional links of friendship that exist between the United States
of America (U.S.) and the European Community (EC);
Desiring to facilitate bilateral trade between them;
Recognizing that mutual recognition of conformity assessment activities is an
important means of enhancing market access between the Parties;
Recognizing that an agreement providing for mutual recognition of conformity
assessment activities is of particular interest to small and medium-sized businesses
in the U.S. and the EC;
Recognizing that any such mutual recognition also requires confidence in the
continued reliability of the other Party's conformity assessments;
Recognizing the importance of maintaining each Party's high levels of health,
safety, environmental and consumer protection;
Recognizing that mutual recognition agreements can positively contribute in
encouraging greater international harmonization of standards;
Noting that this Agreement is not intended to displace private sector bilateral and
multilateral arrangements among conformity assessment bodies or to affect
regulatory regimes allowing for manufacturers' self-assessments and declarations
of conformity.
                                           I
                                            lfi
                                            x u
                                                              Initialled on 20 June 1997
 ---pagebreak--- Bearing in mind that the Agreement on Technical Barriers to Trade, an agreement
annexed to the Agreement establishing the World Trade Organization (WTO),
imposes obligations on the Parties as Contracting Parties to the WTO, and
encourages such Contracting Parties to enter into negotiations for the conclusion of
agreements for the mutual recognition of results of each other's conformity
assessment;
Recognizing that any such mutual recognition needs to offer an assurance of
conformity with applicable technical regulations or standards equivalent to the
assurance offered by the Party's own procedures;
Recognizing the need to conclude an Agreement on Mutual Recognition (MRA) in
the field of conformity assessment with sectoral annexes; and
Bearing in mind the respective commitments of the Parties under bilateral, regional
and multilateral environment, health, safety and consumer protection agreements.
Have agreed as follows:
                                       Article 1
                                   DEFINITIONS
1.   The following terms and definitions shall apply to this Agreement only:
          Designating Authority means a body with power to designate, monitor,
          suspend, remove suspension of, or withdraw conformity assessment
          bodies as specified under this Agreement.
          Designation means the identification by a Designating Authority of a
          conformity assessment body to perform conformity assessment procedures
          under this Agreement.
          Regulatory Authority means a government agency or entity that exercises
          a legal right to control the use or sale of products within a Party's
          jurisdiction and may take enforcement action to ensure that products
          marketed within its jurisdiction comply with legal requirements.
2.    Other terms concerning conformity assessment used in this Agreement shall
      have the meaning given elsewhere in this Agreement or in the definitions
      contained in Guide 2 (1996 edition) of the International Organization for
      Standardization (ISO) and the International Electrotechnical Commission
      (IEC). In the event of an inconsistency between ISO/IEC Guide 2 and
      definitions in this Agreement, the definitions in this Agreement shall prevail.
                                              17               Initialled on 20 June 1997
 ---pagebreak---                                         Article 2
                        PURPOSE OF THE AGREEMENT
This Agreement specifies the conditions by which each Party will accept or
recognize results of conformity assessment procedures, produced by the other
Party's conformity assessment bodies or authorities, in assessing conformity to the
importing Party's requirements, as specified on a sector-specific basis in the
Sectoral Annexes, and to provide for other related cooperative activities. The
objective of such mutual recognition is to provide effective market access
throughout the territories of the Parties with regard to conformity assessment for all
products covered under this Agreement. If any obstacles to such access arise,
consultations will promptly be held. In the absence of a satisfactory outcome of
such consultations, the Party alleging its market access has been denied, may,
within 90 days of such consultation, invoke its right to terminate the Agreement in
accordance with Article 21.
                                       Article 3
                          GENERAL OBLIGATIONS
    The United States shall, as specified in the Sectoral Annexes, accept or
     recognize results of specified procedures, used in assessing conformity to
     specified legislative, regulatory, and administrative provisions of the United
     States, produced by the other Party's conformity assessment bodies and/or
    authorities.
    The European Community and its Member States shall, as specified in the
     Sectoral Annexes, accept or recognize results of specified procedures, used in
    assessing conformity to specified legislative, regulatory and administrative
    provisions of the European Community and its Member States, produced by
    the other Party's conformity assessment bodies and/or authorities.
     Where sectoral transition arrangements have been specified in Sectoral
    Annexes, the above obligations will apply following the successful completion
    of those sectoral transition arrangements, with the understanding that the
    conformity assessment procedures utilized assure conformity to the
    satisfaction of the receiving Party, with applicable legislative, regulatory and
    administrative provisions of that Party, equivalent to the assurance offered by
    the receiving Party's own procedures.
                                            I e^              Initialled on 20 June 1997
 ---pagebreak---                                    Article 4
             GENERAL COVERAGE OF THE AGREEMENT
1. This Agreement applies to conformity assessment procedures for products
   and/or processes and to other related cooperative activities as described in this
   Agreement.
2. Sectoral Annexes may include:
   a)  a description of the relevant legislative, regulatory and administrative
       provisions pertaining to the conformity assessment procedures and
       technical regulations;
   b) a statement on the product scope and coverage;
   c)  a list of Designating Authorities;
   d) a list of agreed conformity assessment bodies or authorities or a source
       from which to obtain a list of such bodies or authorities and a statement of
       the scope of the conformity assessment procedures for which each has
       been agreed;
   e)  the procedures and criteria for designating the conformity assessment
       bodies;
   f)  a description of the mutual recognition obligations;
   g)  a sectoral transition arrangement;
   h) the identity of a sectoral contact point in each Party's territory; and
   i)   a statement regarding the establishment of a Joint Sectoral Committee.
3. This Agreement shall not be construed to entail mutual acceptance of standards
   or technical regulations of the Parties and, unless otherwise specified in a
   Sectoral Annex, shall not entail the mutual recognition of the equivalence of
   standards or technical regulations.
                                         19                 Initialled on 20 June 1997
 ---pagebreak---                                         Articles
                      TRANSITIONAL ARRANGEMENTS
The Parties agree to implement the transitional commitments on confidence
building as specified in the Sectoral Annexes.
1. The Parties agree that each sectoral transitional arrangement shall specify a
     time period for completion.
2. The Parties may amend any transitional arrangement by mutual agreement.
3. Passage from the transitional phase to the operational phase shall proceed as
     specified in each Sectoral Annex, unless either Party documents that the
     conditions provided in such Sectoral Annex for a successful transition are not
     met.
                                        Article 6
                         DESIGNATING AUTHORITIES
The Parties shall ensure that the Designating Authorities specified in the Sectoral
Annexes have the power and competence in their respective territories to carry out
decisions under this Agreement to designate, monitor, suspend, remove suspension
of, or withdraw conformity assessment bodies.
                                         Article 7
                  DESIGNATION AND LISTING PROCEDURES
The following procedures shall apply with regard to the designation of conformity
assessment bodies and the inclusion of such bodies in the list of conformity
assessment bodies in a Sectoral Annex:
     a) The Designating Authority identified in a Sectoral Annex shall designate
          conformity assessment bodies in accordance with the procedures and
          criteria set forth in that Sectoral Annex;
     b) A Party proposing to add a conformity assessment body to the list of such
          bodies in a Sectoral Annex shall forward its proposal of one or more
          designated conformity assessment bodies in writing to the other Party with
          a view to a decision by the Joint Committee;
                                             20             Initialled on 20 June 1997
 ---pagebreak---      c)   Within 60 days following receipt of the proposal, the other Party shall
          indicate its position regarding either its confirmation or its opposition.
          Upon confirmation, the inclusion in the Sectoral Annex of the proposed
          conformity assessment body or bodies shall take effect; and
     d) In the event that the other Party contests on the basis of documented
          evidence the technical competence or compliance of a proposed
          conformity assessment body, or indicates in writing that it requires an
          additional 30 days to more fully verify such evidence, such conformity
          assessment body shall not be included on the list of conformity assessment
          bodies in the applicable Sectoral Annex. In this instance, the Joint
          Committee may decide that the body concerned be verified. After the
          completion of such verification, the proposal to list the conformity
         assessment body in the Sectoral Annex may be resubmitted to the other
          Party.
                                       Article 8
    SUSPENSION OF LISTED CONFORMITY ASSESSMENT BODIES
The following procedures shall apply with regard to the suspension of a conformity
assessment body listed in a Sectoral Annex:
     a)  A Party shall notify the other Party of its contestation of the technical
         competence or compliance of a conformity assessment body listed in a
         Sectoral Annex and the contesting Party's intent to suspend such
         conformity assessment body. Such contestation shall be exercised when
         justified in an objective and reasoned manner in writing to the other Party;
     b) The conformity assessment body shall be given prompt notice by the other
         Party and an opportunity to present information in order to refute the
         contestation or to correct the deficiencies which form the basis of the
         contestation;
     c)  Any such contestation shall be discussed between the Parties in the
         relevant Joint Sectoral Committee. If there is no Joint Sectoral Committee,
         the contesting Party shall refer the matter directly to the Joint Committee.
         If agreement to suspend is reached by the Joint Sectoral Committee or, if
         there is no Joint Sectoral Committee, by the Joint Committee, the
         conformity assessment body shall be suspended;
     d) Where the Joint Sectoral Committee or Joint Committee decides that
          verification of technical competence or compliance is required, it shall
          normally be carried out in a timely manner by the Party in whose territory
          the body in question is located, but may be carried out jointly by the
          Parties in justified cases;
                                               21
                                               ^ —            Initialled on 20 June 1997
 ---pagebreak---     e) If the matter has not been resolved by the Joint Sectoral Committee within
          10 days of the notice of contestation, the matter shall be referred to the
          Joint Committee for a decision. If there is no Joint Sectoral Committee,
          the matter shall be referred directly to the Joint Committee. If no decision
          is reached by the Joint Committee within 10 days of the referral to it, the
          conformity assessment body shall be suspended upon the request of the
          contesting Party;
    f)    Upon the suspension of a conformity assessment body listed in a Sectoral
          Annex, a Party is no longer obligated to accept or recognize the results of
          conformity assessment procedures performed by that conformity
         assessment body subsequent to suspension. A Party shall continue to
         accept the results of conformity assessment procedures performed by that
         conformity assessment body prior to suspension, unless a Regulatory
         Authority of the Party decides otherwise based on health, safety or
         environmental considerations or failure to satisfy other requirements
         within the scope of the applicable Sectoral Annex; and
    g) The suspension shall remain in effect until agreement has been reached by
         the Parties upon the future status of that body.
                                       Article 9
  WITHDRAWAL OF LISTED CONFORMITY ASSESSMENT BODIES
The following procedures shall apply with regard to the withdrawal from a Sectoral
Annex of a conformity assessment body:
    a) A Party proposing to withdraw a conformity assessment body listed in a
         Sectoral Annex shall forward its proposal in writing to the other Party;
    b) Such conformity assessment body shall be promptly notified by the other
         Party and shall be provided a period of at least 30 days from receipt to
         provide information in order to refute or to correct the deficiencies which
         form the basis of the proposed withdrawal;
    c) Within 60 days following receipt of the proposal, the other Party shall
         indicate its position regarding either its confirmation or its opposition.
         Upon confirmation, the withdrawal from the list in the Sectoral Annex of
         the conformity assessment body shall take effect;
                                            Z tj              Initialled on 20 June 1997
 ---pagebreak---   d)     In the event the other Party opposes the proposal to withdraw by
         supporting the technical competence and compliance of the conformity
         assessment body, the conformity assessment body shall not at that time be
         withdrawn from the list of conformity assessment bodies in the applicable
         Sectoral Annex. In this instance, the Joint Sectoral Committee or the Joint
         Committee may decide to carry out a joint verification of the body
         concerned. After the completion of such verification, the proposal for
         withdrawal of the conformity assessment body may be resubmitted to the
         other Party; and
  e)     Subsequent to the withdrawal of a conformity assessment body listed in a
         Sectoral Annex, a Party shall continue to accept the results of conformity
         assessment procedures performed by that conformity assessment body
         prior to withdrawal, unless a Regulatory Authority of the Party decides
         otherwise based on health, safety and environmental considerations or
         failure to satisfy other requirements within the scope of the applicable
         Sectoral Annex.
                                      Article 10
         MONITORING OF CONFORMITY ASSESSMENT BODIES
The following shall apply with regard to the monitoring of conformity assessment
bodies listed in a Sectoral Annex:
    a) Designating Authorities shall assure that their conformity assessment
         bodies listed in a Sectoral Annex are capable and remain capable of
         properly assessing conformity of products or processes, as applicable, and
         as covered in the applicable Sectoral Annex. In this regard, Designating
         Authorities shall maintain, or cause to maintain, ongoing surveillance over
         their conformity assessment bodies by means of regular audit or
          assessment;
    b) The Parties undertake to compare methods used to verify that the
         conformity assessment bodies listed in the Sectoral Annexes comply with
          the relevant requirements of the Sectoral Annexes. Existing systems for
          the evaluation of conformity assessment bodies may be used as part of
          such comparison procedures;
    c) Designating Authorities shall consult as necessary with their counterparts,
          to ensure the maintenance of confidence in conformity assessment
          procedures. With the consent of both Parties, this consultation may
          include joint participation in audits/inspections related to conformity
          assessment activities or other assessments of conformity assessment
          bodies listed in a Sectoral Annex; and
                                              23             Initialled on 20 June 1997
 ---pagebreak---     d) Designating Authorities shall consult, as necessary, with the relevant
         Regulatory Authorities of the other Party to ensure that all technical
         requirements are identified and are satisfactorily addressed.
                                      Article 11
                    CONFORMITY ASSESSMENT BODIES
Each Party recognizes that the conformity assessment bodies listed in the Sectoral
Annexes fulfill the conditions of eligibility to assess conformity in relation to its
requirements as specified in the Sectoral Annexes. The Parties shall specify the
scope of the conformity assessment procedures for which such bodies are listed.
                                      Article 12
                        EXCHANGE OF INFORMATION
1. The Parties shall exchange information concerning the implementation of the
    legislative, regulatory, and administrative provisions identified in the Sectoral
    Annexes.
2.  Each Party shall notify the other Party of legislative, regulatory and
    administrative changes related to the subject matter of this Agreement at least
    60 days before their entry into force. Where considerations of safety, health or
    environmental protection require more urgent action, a Party shall notify the
    other Party as soon as practicable.
3.  Each Party shall promptly notify the other Party of any changes to its
    Designating Authorities and/or conformity assessment bodies.
4.  The Parties shall exchange information concerning the procedures used to
    ensure that the listed conformity assessment bodies under their responsibility
    comply with the legislative, regulatory, and administrative provisions outlined
    in the Sectoral Annexes.
5.  Regulatory Authorities identified in the Sectoral Annexes shall consult as
    necessary with their counterparts, to ensure the maintenance of confidence in
    conformity assessment procedures and to ensure that all technical requirements
    are identified and are satisfactorily addressed.
                                        24
                                                              Initialled on 20 June 1997
 ---pagebreak---                                      Article 13
                         SECTORAL CONTACT POINTS
Each Party shall appoint and confirm in writing contact points to be responsible for
activities under each Sectoral Annex.
                                     Article 14
                    JOINT COMMITTEE OF THE PARTIES
1. The Parties hereby establish a Joint Committee consisting of representatives of
     each Party. The Joint Committee shall be responsible for the effective
     functioning of the Agreement.
2. The Joint Committee may establish Joint Sectoral Committees comprised of
     appropriate Regulatory Authorities and others deemed necessary.
3. Each Party shall have one vote in the Joint Committee. The Joint Committee
     shall make its decisions by unanimous consent. The Joint Committee shall
     determine its own rules and procedures.
4. The Joint Committee may consider any matter relating to the effective
     functioning of this Agreement. In particular it shall be responsible for:
     a) listing, suspension, withdrawal and verification of conformity assessment
          bodies in accordance with this Agreement;
     b) amending transitional arrangements in Sectoral Annexes;
     c) resolving any questions relating to the application of this Agreement and
          its Sectoral Annexes not otherwise resolved in the respective Joint
          Sectoral Committees;
     d) providing a forum for discussion of issues that may arise concerning the
          implementation of this Agreement;
     e) considering ways to enhance the operation of this Agreement;
     0    coordinating the negotiation of additional Sectoral Annexes; and
     g) considering whether to amend this Agreement or its Sectoral Annexes in
          accordance with Article 21.
                                         10
                                          25                   Initialled on 20 June 1997
 ---pagebreak--- 5. When a Party introduces new or additional conformity assessment procedures
    affecting a Sectoral Annex, the Parties shall discuss the matter in the Joint
    Committee with a view to bringing such new or additional procedures within
    the scope of this Agreement and the relevant Sectoral Annex.
                                     Article 15
             PRESERVATION OF REGULATORY AUTHORITY
1. Nothing in this Agreement shall be construed to limit the authority of a Party
    to determine, through its legislative, regulatory and administrative measures,
    the level of protection it considers appropriate for safety; for protection of
    human, animal, or plant life or health; for the environment; for consumers; and
    otherwise with regard to risks within the scope of the applicable Sectoral
    Annex.
2. Nothing in this Agreement shall be construed to limit the authority of a
    Regulatory Authority to take all appropriate and immediate measures
    whenever it ascertains that a product may: (a) compromise the health or safety
    of persons in its territory; (b) not meet the legislative, regulatory, or
    administrative provisions within the scope of the applicable Sectoral Annex; or
    (c) otherwise fail to satisfy a requirement within the scope of the applicable
    Sectoral Annex. Such measures may include withdrawing the products from
    the market, prohibiting their placement on the market, restricting their free
    movement, initiating a product recall, and preventing the recurrence of such
    problems, including through a prohibition on imports. If the Regulatory
    Authority takes such action, it shall inform its counterpart authority and the
    other Party within fifteen days of taking such action, providing its reasons.
                                     Article 16
             SUSPENSION OF RECOGNITION OBLIGATIONS
Either Party may suspend its obligations under a particular Sectoral Annex, in
whole or in part, if:
a) a Party suffers a loss of market access for the Party's products within the scope
    of the Sectoral Annex as a result of the failure of the other Party to fulfill its
    obligations under the Agreement;
b) the adoption of new or additional conformity assessment requirements as
    referenced in Article 14(5) results in a loss of market access for the Party's
    products within the scope of the Sectoral Annex because conformity
    assessment bodies designated by the Party in order to meet such requirements
    have not been recognized by the Party implementing the requirements; or
                                         II
                                           26
                                                             Initialled on 20 June 1997
 ---pagebreak--- c) the other Party fails to maintain legal and regulatory authorities capable of
     implementing the provisions of this Agreement.
                                     Article 17
                               CONFIDENTIALITY
1. Each Party agrees to maintain, to the extent required under its laws, the
     confidentiality of information exchanged under this Agreement.
2. In particular, neither Party shall disclose to the public, nor permit a conformity
     assessment body to disclose to the public, information exchanged under this
     Agreement that constitutes trade secrets, confidential commercial or financial
     information, or information that relates to an ongoing investigation.
3. A Party or a conformity assessment body may, upon exchanging information
     with the other Party or with a conformity assessment body of the other Party,
     designate the portions of the information that it considers to be exempt from
     disclosure.
4. Each Party shall take all precautions reasonably necessary to protect
     information exchanged under this Agreement from unauthorized disclosure.
                                     Article 18
                                        FEES
Each Party shall endeavor to ensure that fees imposed for services under this
Agreement shall be commensurate with the services provided. Each Party shall
ensure that, for the sectors and conformity assessment procedures covered under
this Agreement, it shall charge no fees with respect to conformity assessment
services provided by the other Party.
                                      Article 19
                  AGREEMENTS WITH OTHER COUNTRIES
Except where there is written agreement between the Parties, obligations contained
in mutual recognition agreements concluded by either Party with a party not a
signatory to this Agreement (a third party) shall have no force and effect with
regard to the other Party in terms of acceptance of the results of conformity
assessment procedures in the third party.
                                          12
                                            27                Initialled on 20 June 1997
 ---pagebreak---                                       Article 20
                         TERRITORIAL APPLICATION
This Agreement shall apply, on the one hand, to the territories in which the Treaty
establishing the European Community is applied, and under the conditions laid
down in that Treaty and, on the other hand, to the territory of the United States.
                                      Article 21
        ENTRY INTO FORCE, AMENDMENT AND TERMINATION
1. This Agreement including its Sectoral Annexes on Telecommunications
     Equipment, Electromagnetic Compatibility, Electrical Safety, Recreational
     Craft, Pharmaceutical GMP Inspections, and Medical Devices shall enter into
     force on the first day of the second month following the date on which the
     Parties have exchanged letters confirming the completion of their respective
     procedures for the entry into force of this Agreement.
2. This Agreement including any Sectoral Annex may, through the Joint
     Committee, be amended in writing by the Parties. The Parties may add a
     Sectoral Annex upon the exchange of letters. Such Annex shall enter into force
     30 days following the date on which the Parties have exchanged letters
     confirming the completion of their respective procedures for the entry into
     force of the Sectoral Annex.
3. Either Party may terminate .this Agreement in its entirety or any individual
     Sectoral Annex thereof by giving the other Party six months notice in writing.
     In the case of termination of one or more Sectoral Annexes, the Parties will
    seek to achieve by consensus to amend this Agreement, with a view to
    preserving the remaining Sectoral Annexes, in accordance with the procedures
     in this Article. Failing such consensus, the Agreement shall terminate at the
    end of six months.
4. Following termination of the Agreement in its entirety or any individual
     Sectoral Annex thereof, a Party shall continue to accept the results of
     conformity assessment procedures performed by conformity assessment bodies
     under this Agreement prior to termination, unless a Regulatory Authority in
     the Party decides otherwise based on health, safety and environmental
     considerations or failure to satisfy other requirements within the scope of the
     applicable Sectoral Annex.
                                          13
                                         28                   Initialled on 20 June 1997
 ---pagebreak---                                        Article 22
                               FINAL PROVISIONS
1. The Sectoral Annexes referred to in Article 21.1, as well as any New Sectoral
    Annexes added pursuant to Article 21.2, shall form an integral part of this
    Agreement.
2. For a given product or sector, the provisions contained in the relevant Sectoral
    Annexes shall apply in the first place, and the provisions of this text in
    addition to those provisions. In the case of any inconsistency between the
    provisions of a Sectoral Annex and this text, the Sectoral Annex shall prevail,
    to the extent of that inconsistency.
3. This Agreement shall not affect the rights and obligations of the Parties under
    any other international agreement.
4.  In the case of the Sectoral Annex on Medical Devices, the Parties shall review
    the status of such Annex at the end of three yearsfromentry into force.
This Agreement and the Sectoral Annexes are drawn up in two originals in the
Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese,
Spanish and Swedish languages, each text being equally authentic. In the event of
inconsistencies of interpretation, the English text shall be determinative.
DONE at         this      day of     , 1997.
FOR THE GOVERNMENT OF THE FOR THE EUROPEAN COMMUNITY:
UNITED STATES OF AMERICA:
                                          14
                                              29               Initialled on 20 June 1997
 ---pagebreak---  US - EC MRA Telecommunication Equipment Annex
                                             EC - U.S. MRA
                                       SECTORAL ANNEX
                                                 FOR
                         TELECOMMUNICATION EQUIPMENT
PREAMBLE
Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual
Recognition of Conformity Assessment between the United States and the European
Community,
                                           15
                                             30
                                                                 Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                          SECTION I
      LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
                 EC                                                           U.S.
 Council Directive 91/263/EEC, as                 Communication Act of 1934, as amended by
 supplemented by Council Directive                the Telecommunication Act of 1996, (Title
 93/97/EEC and amended by Council                 47 of the United States Code),
 Directive 93/68/EEC, and interpretation
 thereof;                                         the U.S. regulatory and administrative
                                                  provisions in respect of telecommunication
 (The Parties recognize that the Handbook         equipment, including 47 CFR Part 68, and
 on the implementation of Directive               FCC interpretation thereof;
 91 /263/EEC (ADLNB and ACTE
 approved), provides useful guidelines for        (The Parties recognize that the FCC Form
 the implementation of conformity                 730 Application Guide provides useful
 assessment procedures falling under this         guidelines for the implementation of
 Directive.);                                     conformity assessment procedures for
                                                  telecommunication terminal equipment
 Commission Decisions (CTRs) established          falling within these regulations.);
 under Council Directives 91/263/EEC and
 93/97/EEC;             •»'                       The U.S. regulatory and administrative
                                                  provisions in respect of all radio transmitters
 The EC Member States' legislation and            subject to an equipment authorization
 regulations in respect of:                       requirement. A non-exclusive list of FCC
 (a) non-harmonized analogue connection to        regulations are contained in Section II;
 the public telecommunications network*;
 (b) non-harmonized radio transmitters-for        For electrical safety, see Electrical Safety
 which there is a civilian equipment              Sectoral Annex to the Agreement;
 authorization requirement;
                                                  For electromagnetic compatibility aspects,
 * The EC agrees to seek authority to             see Electromagnetic Compatibility (EMC)
 include non-harmonized digital                   Sectoral Annex to the Agreement,
 connections;
 For electrical safety, see Electrical Safety
 Sectoral Annex to the Agreement;
 For electromagnetic compatibility aspects,
 see Electromagnetic Compatibility (EMC)
 Sectoral Annex to the Agreement.
                                              16
                                                 31                  Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                      SECTION II
                              SCOPE AND COVERAGE
      This Sectoral Annex shall apply to equipment, interfaces, and services subject
      to Section I. In general terms the provisions of this Sectoral Annex shall apply
      to the following types of telecommunications terminal equipment, satellite
      terminal equipment, radio transmitters, and information technology
      equipment:
      (a)     equipment intended for connection to the public telecommunications
              network in order to send, process or receive information, whether the
              equipment is to be connected directly to the "termination" of the
              network or to inter-work with such a network, being connected directly
              or indirectly to the termination point. The system of connection may
              be wire, radio, optical or other electro-magnetic means;
      (b)     equipment capable of being connected to a public telecommunications
              network even if it is not its intended purpose, including information
              technology equipment having a communication port; and
      (c)     all radio transmitters subject to an equipment authorization procedure
              by either Party.
      The following is a non-exclusive list of the equipment, interfaces, and services
      included within the scope of this Sectoral Annex:
                                          17
                                               32<6            Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                 SECTION II (continued)
                               SCOPE AND COVERAGE
                EC                                                       US.
 The following equipment categories    Equipment categories covered under 47 CFR Part
 are included :                        68, including:
 ISDN Basic Rate Access                ISDN Basic Access
 ISDN Primary Rate Access              ISDN Primary Rate Access
 ISDN Telephony                        Digital Service Access :
 X21/V.24/V.35 Access                   2.4 kbps
 X25 Access                             3.2 kbps (2.4 kbps with Secondary Channel)
 PSTN Non-Voice                         4.8 kbps
 PSTN Voice Band (Analog)               6.4 kbps (4.8 kbps with SC)
 ONP Leased Line Terminal types :       9.6 kbps
 -64 kbits/sec                         12.8 kbps (9.6 kbps with SC)
 -2048 kbits/s unstructured            19.2 kbps
 -2048 kbits/s structured              25.0 kbps (19.2 kbps with SC)
 -34 Mbits/s access            *       56.0 kbps
 -140 Mbits/s access                   64.0 kbps (uses 72 kbps channel)
 -2 wire analogue                      72.0 kbps (56.0 kbps with SC)
 -4 wire analogue                        1.544 Mbps
                                       2 wires analog tie trunks/ops
 Radio transmitters subject to an      4 wire analog tie trunks/ops
 equipment authorization               PSTN Voice Band (Analog) Access
 requirement, including:               Private Line (Analog) Access
 (List to be provided before signing   Radio transmitters subject to an equipment
 of Sectoral Annex.)                   authorization requirement, including:
                                       Commercial Mobile Radio            (Part 20)
                                       Domestic Public Fixed              (Part 21)
                                       Domestic Mobile                    (Part 22)
                                       Personal Communication Service (Part 24)
                                       Satellite Communications           (Part 25)
                                       Broadcast                          (Part 73)
                                       Auxiliary Broadcast                (Part 74)
                                       Cable Television Radio             (Part 78)
                                       Maritime                           (Part 80)
                                       GMDSS                              (Part 80W)
                                       Private Land Mobile                (Part 90)
                                       Private-Fixed Microwave            (Part 94)
                                       Personal Radio Services            (Part 95)
                                       IVDS                               (Part 95 F)
                                       Amateur Radio                      (Part 97)
                                       Radio Frequency Devices             (Part 15)
                                       Fixed Microwave Services           (Part 101)
Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral
Annex.
                                          18
                                              33                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                          SECTION III
                     CONFORMITY ASSESSMENT PROCEDURES
                     FOR TELECOMMUNICATION EQUIPMENT
 1.        Description of Mutual Recognition Obligations
In accordance with the provisions of the Agreement, the results of the conformity assessment
procedures produced by a Party's conformity assessment bodies listed in Section V.shall be
recognized by the Regulatory Authorities of the other Party without any further conformity
assessment of the products, pursuant to Section I.
2,        Conformity Assessment Procedures
Taking into account the legislative, regulatory, and administrative provisions as identified in
Section I, each Party recognizes that the conformity assessment bodies of the other Party,
listed in Section V, are authorized to perform the following procedures with regard to the
importing Party's technical requirements for telecommunications terminal equipment,
satellite terminal equipment, radio transmitters or information technology equipment:
         a)       testing and issuing of test reports;
          b)      issuing certificates of conformity to the requirements of the laws and
                  regulations applicable in the territories of the Parties for products covered
                  under this Sectoral Annex; and
         c)       performing quality assurance certification pursuant to Council Directive
                 91/263/EEC.
                                                19
                                                   34               Initialled on 20 June 1997
 ---pagebreak---  US - EC MRA Telecommunication Equipment Annex
                                      SECTION IV
                AUTHORITIES RESPONSIBLE FOR DESIGNATING THE
             CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
                        EC                                           U.S.
   Austria:                                                       National Institute of
   Bundesministerium furWissenschaft,Verkehr und Lumst.           Standards and
                                                                  Technology (NIST)
   Belgium:
   BIPT.                                                          Federal
                                                                  Communications
  Denmark:                                                        Commission (FCC)
  Telestyrelsen.
  Finland:
  Telecommunications Administration Centre.
  Germany:
  Bundesministerium fur Wirtschaft (Bonn)
  Greece:
  Ministry of Transport & Communications.
  France:
  Direction Generate des Postes & Telecommunications
  Ireland:
  Dept. of Transport, Energy & Communications.
  Italy:
  Ispettorato General TLC.
  Luxembourg:
  Administration des Postes et Telecommunications.
  Netherlands:
  Min. Verkeer en Waterstaat, Telecom, en Post Department.
  Portugal:
  Instituto das Communicacoes.
  Spain:
  Ministerio de Formento
  Sweden:
  National Post & Telecom Agency + SWEDAC.
  UK:
I Dept of Trade & Industry .
                                          20
                                            35             Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                        SECTION V
                         CONFORMITY ASSESSMENT BODIES
                EC                                                       US;
 Conformity assessment bodies located in       Conformity assessment bodies located in
 the EC shall be designated by the             the U.S. shall be designated by the
 Authorities identified in Section IV          Authorities identified in Section IV
 following the procedures set out in Section   following the procedures set out in Section
 VI of this Annex.                             VI of this Annex.
 (to be provided by the EC upon notification   (to be provided by the U.S.)
 by the Member States).
                                           21
                                              36                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                        SECTION VI
 DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING
           CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
        EC                                                     U.S.
 EC Access to U.S. Market:                     U.S. Access to EC Market:
 EC Authorities identified in Section IV       U.S. Authorities identified in Section IV
 shall designate conformity assessment        shall designate conformity assessment
 bodies located in the EC in accordance with  bodies located in the U.S. in accordance
 the U.S. legislative, regulatory, and        with the EC legislative, regulatory, and
 administrative provisions identified in      administrative provisions identified in
 Section I that govern designation of         Section I that govern designation of
 conformity assessment bodies, based on       conformity assessment bodies, based on
 compliance with the appropriate ISO/IEC      compliance with the appropriate EN-45000
 Guides (e.g. Guide 22, 25, 28, 58, 61, 62,   Series Standards or the comparable
 6J, etc.) or the comparable EN-45000 Series  ISO/IEC Guides (e.g. Guide 22, 25, 28, 58,
 Standards.                                   61, 62, 65, etc.).
 Procedures for designating, listing,         Procedures for designating, listing,
 suspending, withdrawing, and monitoring a    suspending, withdrawing, and monitoring a
 conformity assessment body listed in         conformity assessment body listed in
 Section V shall be undertaken pursuant to    Section V shall be undertaken pursuant to
 Articles 7, 8, 9, and 10 of the Agreement.   Articles 7, 8, 9, and 10 of the Agreement.
                                               37                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                        SECTION VII
                                ADDITIONAL PROVISIONS
1. SUB - CONTRACTING
   1.1 Any sub-contracting by conformity assessment bodies shall be in accordance with
       the sub-contracting requirements of the other Party. Notwithstanding the use of
       sub-contracting, the final results of conformity assessment remain the full
       responsibility of the listed conformity assessment body. In the EC, these
       requirements are described in Council Decision 93/465/EEC.
   1.2 The conformity assessment bodies shall record and retain details of their
       investigation of the competence and compliance of their subcontractors and maintain
       a register of all sub-contracting. These details will be available to the other Party on
       request.
2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND INTERNAL
   MOVEMENT
   2.1 For the purpose of post-market surveillance, the Parties may maintain any existing
       labeling and numbering requirements. The assignment of the numbers may take
       place in the territory of the exporting Party. The numbers will be allocated by the
       importing Party. Numbering and labeling systems shall not introduce additional
       requirements within the meaning of this Sectoral Annex.
   2.2 Nothing in this Sectoral Annex shall prevent the Parties from removing products
       from the market that do not in fact conform to the requirements for approval.
   2.3 The Parties agree that border inspections and checks of products which have been
       certified, labeled or marked as conforming with the importing Party's requirements
       specified in Section I shall be completed as expeditiously as possible. With regard to
       any inspections related to internal movement within their respective territories, the
       Parties agree that these shall be completed in no less a favorable manner than for
       like-domestic goods.
3. JOINT SECTORAL COMMITTEE
   3.1 A combined Joint Sectoral Committee for this Sectoral Annex and the EMC Sectoral
       Annex is hereby established (the JSC). The JSC shall operate during the transitional
       period and after completion of the transitional arrangement. The JSC shall meet as
       appropriate to discuss technical, conformity assessment and technology issues
       relating to this Sectoral Annex and the EMC Sectoral Annexes. The JSC shall
       determine its own rules of procedure.
                                               38                   Initialled on 20 June 1997
 ---pagebreak---  US - EC MRA Telecommunication Equipment Annex
     3.2 The JSC consists of representatives of the U.S. and the EC for telecommunications
         and EMC. JSC representatives may each invite manufacturers and other entities as
         deemed necessary. The representatives for the U.S. shall have one vote in the JSC.
         The representatives of the EC shall have one vote in the JSC. Decisions of the JSC
         shall be made by unanimous consent. In the event of disagreement either the U.S. or
         EC representative may raise the matter in the Joint Committee.
     3.3 The JSC may address any matter related to the effective functioning of this Sectoral
         Annex, including:
             a) providing a forum for discussion of issues and resolving problems that may
             arise concerning the implementation of this Sectoral Annex;
             b) developing a mechanism for ensuring consistency of interpretations of
             legislation, regulations, standards, and conformity assessment procedures;
             c) advising the Parties on matters relating to this Sectoral Annex; and
             d) providing guidance and, if necessary, developing guidelines during the
             transitional period to facilitate the successful completion of the transitional
             period.
4. CONTACT POINT
Each Party shall establish a contact point to provide answers to all reasonable inquiries from
the other Party regarding procedures, regulations, and complaints under this Sectoral Annex.
5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX
In the event that there are changes to the legislative, regulatory, and administrative provisions
referenced in Section I or the introduction of new legislative, regulatory, and administrative
provisions affecting either Party's conformity assessment procedures under the Agreement,
such changes shall take effect for the purpose of this Sectoral Annex at the same time they
take effect domestically within the territory of each Party. The Parties shall update this
Sectoral Annex to reflect the changes.
                                                24
                                                      39              Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
                                        SECTION VIII
                            TRANSITIONAL ARRANGEMENT
1. There shall be a transitional period of 24 months.
2. The purpose of this transitional arrangement is to provide a means whereby the Parties to
   the Agreement can build confidence in and an understanding of each other's system for
   designating and listing conformity assessment bodies and in the ability of these bodies to
   test and certify products. Successful completion of the transitional arrangement should
   result in the determination that conformity assessment bodies listed in Section V comply
   with the applicable criteria and are competent to conduct conformity assessment
   activities on behalf of the other Party. Upon successful completion of the transition
   period, the results of conformity assessment procedures performed by the exporting
   Party's conformity assessment bodies listed in Section V of the exporting country shall
   be accepted by the importing Party.
3. This transitional period shall be used by the Parties:
   a) to consider new legislative changes needed to support the objectives of the
        Agreement;
   b) to initiate regulatory changes needed to support the objectives of the Agreement;
   c) to exchange information on and develop better understanding of their respective
        regulatory requirements;
   d) to develop mutually agreed mechanisms for exchanging information on changes in
        technical requirements or methods of designating conformity assessment bodies; and
   e) to monitor and evaluate the performance of the listed conformity assessment bodies
        during the transitional period.
4. Parties may designate, list, suspend and withdraw conformity assessment bodies during
   the transitional period according to the procedures in Section VI of this Sectoral Annex.
5. During the transitional period each Party shall accept and evaluate test reports and
   related documents issued by designated conformity assessment bodies of the other Party.
   To this end, the Parties shall ensure that:
   a) on receipt of test reports, related documents and a first evaluation of conformity, the
        dossiers are promptly examined for completeness;
    b) the applicant is informed in a precise and complete manner of any deficiency;
   c) any request for additional information is limited to omissions, inconsistencies or
        variances from the technical regulations or standards; and
    d) procedures for assessing the conformity for equipment modified subsequent to a
        determination of compliance, are limited to procedures necessary to determine
        continued conformance.
6. Each Party ensures that issuance of approvals, certificates, or advice to the applicant
    shall be given no later than six weeks from receipt of the test report and evaluation from
    a designated conformity assessment body in the territory of the other Party.
                                             25
                                               40                    Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Telecommunication Equipment Annex
7. Any proposal made during or at the end of the transitional period to limit the scope of
   recognition of any designated conformity assessment body or to exclude it from the list
   of bodies designated under this Sectoral Annex shall be based on objective criteria and
   documented. Any such body may apply for reconsideration once the necessary
   corrective action has been taken. To the extent possible, the Parties shall implement such
   action prior to the expiry of the transitional period.
8. The Parties may jointly sponsor two seminars, one in the U.S. and one in the European
   Community, concerning the relevant technical and product approval requirements during
   the first year after this Sectoral Annex enters into force.
9. Passage from the transitional phase into the operational phase in this Sectoral Annex
   shall take place provided that a representative number of conformity assessment bodies
   have been accepted for recognition under the Electrical Safety Annex.
                                              26
                                                 41               Initialled on 20 June 1997
 ---pagebreak---  US - EC MRA Telecommunication Equipment Annex
                                     APPENDIX 1
                     LISTS OF ACRONYMS AND GLOSSARY
ACTE      Approvals Committee for Terminal Equipment
ADLNB     Association of Designated Laboratories and Notified Bodies
CAB      Conformity Assessment Body
CFR       U.S. Code of Federal Regulations, Title 47 CFR
CTR      Common Technical Regulation
EC        European Community
EEC       European Economic Community
EN       Norme Européenne (European Standard)
EU       European Union
FCC      Federal Communications Commission
IEC      International Electrotechnical Commission
ISDN     Integrated Services Digital Network
ISO      International Standards Organization
ITU      International Telecommunications Union
MRA      Mutual Recognition Agreement
MS       Member States (of the European Union)
NB       Notified Bodies
NIST     National Institute of Standards and Technology
OJ       Official Journal (of the European Union)
ONP      Open Network Provision
PSTN     Public Switched Telephone Network
STG      Sectoral Technical Group for Telecommunications
TBR      Technical Basis for Regulation
X21      ITU-T Recommendation X21
X25      ITU-T Recommendation X25
                                      40                      Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                      EU - U.S. MRA
                                  SECTORAL ANNEX
                                        FOR
                         ELECTROMAGNETIC COMPATIBILITY
                                         (EMC)
PREAMBLE
Recognizing that this Annex constitutes a Sectoral Annex to the framework
Agreement on Mutual Recognition of Conformity Assessment between the United
States and the European Community.
                                    29
                                       43            initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                      SECTION I
      LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
                        EC                                                  U.S.
 Council Directive 89/336/EEC, as amended by         Communications Act of 1934. as
 Council Directives 91/263/EEC, 92/31/EEC,           amended by -the Telecommunication Act
 93/68/EEC and 93/97/EEC and interpretation          of 1996, (Title 47 of the United States
 thereof.                                            Code),
 For electrical safety aspects see Electrical Safety the U.S. regulatory and administrative
 Sectoral Annex to the Agreement.                    provisions in respect of equipment subject
                                                     to      electromagnetic           requirements
 For telecommunication equipment and radio           including:
 transmitters, see also Telecommunications              -47CFRPartl5
 Equipment Sectoral Annex to the Agreement.             -47CFRPartl8,
                                                     and FCC interpretation thereof.
                                                     For electrical -safety aspects see Electrical
                                                     Safety Sectoral Annex to the Agreement.
                                                     For telecommunication equipment and
                                                     radio        transmitters,        see     also
                                                     Telecommunications Equipment Sectoral
                                                     Annex to the Agreement.
                                     SECTION II
                              SCOPE AND COVERAGE
                   EC                                                US.
 For US access to the EU market:              For EU access to the US market:
 Any product falling under the scope of       Any products falling under the scope of
 Council Directive 89/336/EEC.                47 CFR Part 15 and 18.
                                         30
                                           44               Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                       SECTION III
                  CONFORMITY ASSESSMENT PROCEDURES
                 FOR EQUIPMENT IDENTIFIED IN SECTION II
1.       Description of Mutual Recognition Obligations
In accordance with the provisions of the Agreement, the results of the conformity
assessment procedures produced by a Party's conformity assessment bodies listed in
Section V, shall be recognized by the Regulatory Authorities of the other Party
without any further conformity assessment of the products, pursuant to Section I.
2.       Conformity Assessment Procedures
Taking into account the legislative, regulatory, and administrative provisions as
identified in Section I, each Party recognizes that the conformity assessment bodies of
the other Party, listed in Section V, are authorized to perform the following
procedures with regard to the importing Party's technical requirements for equipment
identified in Section II:
  a)    testing and issuing of test reports;
  b)     issuing certificates of conformity to the requirements of the laws and
        regulations applicable in the territories of the Parties for products covered
        under this Sectoral Annex.
                                            31
                                             45                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                    SECTION IV
           AUTHORITIES RESPONSIBLE FOR DESIGNATING THE
        CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
                           EU                                    Ujj.
 Austria:        Bundesministerium fur         National Institute of Standards and
          wirtschaftliche Angelegenheiten      Technology (NIST)
    Abteilung
 Belgium:                                      Federal Communications Commission
 Denmark:                                      (FCC)
 Finland:
 France:                                       Federal Aviation Administration
 Germany:                                      (FAA)
 Greece:
 Ireland:
 Italy:
 Luxemburg:
 Netherlands:
 Portugal:
 Spain:
 Sweden:
 U.K.:
 (list to be completed later)
                                          46          Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                 SECTION V
                    CONFORMITY ASSESSMENT BODIES
                         EC                                          ILS.
      For EC access to the U.S. market:          For U.S. access to the EC market:
      Conformity assessment bodies located in Conformity assessment bodies located
      the EC shall be designated by the       in the U.S. shall be designated by the
      Authorities identified in Section IV    Authorities identified in Section IV
      following the procedures set out in     following the procedures set out in
      Section VI of this Annex.               Section VI of this Annex.
      (to be provided by the EC)              (to be provided by the U.S.)
                                     33
                                     47                 Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                     SECTION VI
      DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND
                                   MONITORING
       CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
                         EC                                          U.S.
 EC Access to U.S. Market:                   U.S. Access to EC Market:
 EC Authorities identified in Section IV     U.S. Authorities identified in Section IV
 shall designate conformity assessment       shall designate conformity assessment
 bodes located in the EC in accordance with  bodies located in the U.S. in accordance
 the U.S. legislative, regulatory^ and       with the EC legislative, regulatory, and
 administrative provisions identified in     administrative provisions identified in
 Section I that govern designation of        Section I that govern designation of
 conformity assessment bodies, based upon    conformity assessment bodies, based on
 compliance with the appropriate ISO/IEC     compliance with the appropriate EN-45000
 Guides (e.g. Guide 22, 25, 28, 58, 61, 62,  Series Standards or the comparable
 65, etc.) or the comparable EN-45000        ISO/IEC Guides (e.g. Guide 22, 25, 28, 58,
 Series Standards.                           61, 62, 65, etc.).
 Procedures for designating, listing,        Procedures for designating, listing,
 suspending, withdrawing, and monitoring a   suspending, withdrawing, and monitoring a
 conformity assessment body listed in        conformity assessment body listed in
 Section V shall be undertaken pursuant to   Section V shall be undertaken pursuant to
 Articles 7, 8, 9, and 10 of the Agreement.  Articles 7, 8, 9, and 10 of the Agreement.
                                        34
                                       48                   Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                       SECTION VII
                             ADDITIONAL PROVISIONS
 1.     SUB - CONTRACTING
   1.1 Any sub-contracting by conformity assessment bodies shall be in accordance
       with the sub-contracting requirements of the other Party. Notwithstanding the
       use of sub-contracting, the final results of conformity assessment remain the
        full responsibility of the listed conformity assessment body. In the EC, these
        requirements are described in Council Decision 93/465/EEC.
   1.2 The conformity assessment bodies shall record and retain details of its
       investigation of the competence and compliance of its subcontractors and
       maintain a register of ail sub-contracting. These details will be available to the
       other Party on request.
2.      POST-MARKET SURVEILLANCE, BORDER MEASURES AND
          INTERNAL MOVEMENT
   2.1 For the purpose of post-market surveillance, the Parties may maintain any
       existing labeling and numbering requirements. The assignment of the numbers
       may take place in the territory of the exporting Party. The numbers will be
       allocated by the importing Party. Numbering and labeling systems shall not
       introduce additional requirements within the meaning of this Sectoral Annex.
   2.2 Nothing in this Sectoral Annex shall prevent the Parties from removing
       products from the market that do not in fact conform to the requirements for
       approval.
   2.3 The Parties agree that border inspections and checks of products which have
       been certified, labeled or marked as conforming with the importing Party's
       requirements specified in Section I shall be completed as expeditiously as
       possible. With regard to any inspections related to internal movement within
       their respective territories, the Parties agree that these shall be completed in no
       less a favorable manner than for like-domestic goods.
3.     JOINT SECTORAL COMMITTEE
  3.1 A combined Joint Sectoral Committee for this Sectoral Annex and the
       Telecommunications Equipment Sectoral Annex is hereby established (the
       JSC). The JSC shall operate during the transitional period and after completion
       of the transitional arrangement. The JSC shall meet as appropriate to discuss
       technical, conformity assessment and technology issues relating to this
       Sectoral Annex and the Telecommunications Equipment Sectoral Annex. The
       JSC shall determine its own rules of procedure.
                                           35
                                           49
                                                                 Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
  3.2   The JSC consists of representatives of the U.S. and the EC for
        telecommunications and EMC. JSC representatives may each invite
        manufacturers and other entities as deemed necessary. The representatives for
        the U.S. shall have one vote in the JSC. The representatives of the EC shall
        have one vote in the JSC. Decisions of the JSC shall be made by unanimous
        consent. In the event of disagreement either the U.S. or EC representatives
        may raise the matter in the Joint Committee.
  3.3   The JSC may address any matter related to the effective functioning of this
        Sectoral Annex, including :
                 a)      providing a forum for discussion of issues and resolving
                         problems that may arise concerning the implementation of
                         this Sectoral Annex;
                 b)      developing a mechanism for ensuring consistency of
                         interpretations of legislation, regulations, standards, and
                         conformity assessment procedures.
                 c)      advising the Parties on matters relating to this Sectoral
                         Annex;
                 d)      providing guidance and, if necessary, developing guidelines
                         during the transitional period to facilitate the successful
                         completion of the transitional period.
4.    CONTACT POINT
Each Party shall establish a contact point to provide answers to all reasonable
inquiries from the other Party regarding procedures, regulations and complaints under
this Sectoral Annex.
5.    REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX
In the event that there are changes to the legislative, regulatory and administrative
provisions referenced in Section I or the introduction of new legislative, regulatory
and administrative provisions affecting either Party's conformity assessment
procedures under the Agreement, such changes shall take effect for the purpose of this
Sectoral Annex at the same time they take effect domestically within the territory of
each Party. The Parties shall update this Sectoral Annex to reflect the changes.
                                          36
                                           50                   Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatibility Annex
                                     SECTION VIII
                         TRANSITIONAL ARRANGEMENT
1. There shall be a transitional period of 24 months.
2. The purpose of this transitional arrangement is to provide a means whereby the
   Parties to the Agreement can build confidence in and understanding of each others
   system for designating and listing conformity assessment bodies and in the ability
   of these bodies to test and certify products. Successful completion of the transition
   arrangement should result in the determination that conformity assessment bodies
   listed in Section V comply with the applicable criteria and are competent to
   conduct conformity assessment activities on behalf of the other Party. Upon
   completion of the transition period, the results of conformity assessment
   procedures performed by the exporting Party's conformity assessment bodies listed
   in Section V shall be accepted by the importing Party.
3. This transitional period shall be used by the Parties :
     a) to consider new legislative changes needed to support the objectives of the
        Agreement;
     b) to initiate regulatory changes needed to support the objectives of the
        Agreement;
     c) to exchange information on and develop better understanding of their
        respective regulatory requirements;
     d) to develop mutually agreed mechanisms for exchanging information on
        changes in technical requirements or methods of designating conformity
        assessment bodies; and
     e) to monitor and evaluate the performance of the listed conformity assessment
        bodies during the transitional period.
4. Parties may designate, list, suspend and withdraw conformity assessment bodies
   during the transitional period according to the procedures in Section VI of this
   Sectoral Annex.
5. During the transitional period each Party shall accept and evaluate test reports and
   related documents issued by designated conformity assessment bodies of the other
   Party. To this end, the Parties shall ensure that:
     - on receipt of test reports, related documents and a first evaluation of
        conformity, the dossiers are promptly examined for completeness;
     - the applicant is informed in a precise and complete manner of any deficiency;
     - any request for additional information is limited to omissions, inconsistencies
        or variances from the technical regulations or standards;
     - procedures for assessing the conformity for equipment modified subsequent to
        a determination of compliance, are limited to procedures necessary to
        determine continued conformance;
                                          37
                                            ^ —                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electromagnetic Compatib ility Annex
6. Each Party ensures that issuance of approvals, certificates or advice to the applicant
   shall be given no later than six weeks from receipt of the test report and evaluation
   from a designated conformity assessment body in the territory of the other Party.
7. Any proposal made during or at the end of the transitional period to limit the scope
   of recognition of any designated conformity assessment body or to exclude it from
   the list of bodies designated under this Sectoral Annex shall be based on objective
   criteria and documented. Any such body may apply for reconsideration once the
   necessary corrective action has been taken. To the extent possible, the Parties shall
   implement such action prior to the expiry of the transitional period.
8. The Parties may jointly sponsor two seminars, one in U.S. and one in the European
   Community, concerning the relevant technical and product approval requirements
   during thefirstyear after this Sectoral Annex enters into force.
9. Passage from the transitional phase into the operational phase in this Sectoral
   Annex shall take place provided that a representative number of conformity
   assessment bodies have been accepted for recognition under the Electrical Safety
   Annex.
                                           O
                                           fa
                                                               Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electrical Safety Annex
                               EC-U.S. MRA
                              SECTORAL ANNEX
                                        FOR
                             ELECTRICAL SAFETY
PREAMBLE
Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual
Recognition between the United States and the European Community.
                                        39
                                         53                  Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electrical Safety Annex
                                    SECTION I
   LEGISLATIVE REGULATORY AND ADMINISTRATIVE PROVISIONS
                        EC                                                  IXS.
 For U.S. access to the EC market:                     For EC access to the U.S. market
 Council Directive 73/23/EEC of 19 February          29 U.S.C. 651 et seq.
  1973 as amended by 93/68/EEC.                     U.S. 29 CFR 1910.7
                                                    Products that are certified or approved
                                                    under the Federal Mine Safety and Health
                                                    Act (30 U.S.C. 801fiLsegJor its
                                                    regulations and used in areas under the
                                                    authority of the Mine Safety and Health
                                                    Administration, are not covered under this
                                                    Annex.
                                                    OSHA will consider regulatory and
                                                    legislative changes needed to support the
                                                    objectives of the MRA.
 For medical devices, see the Medical Devices       For medical devices, see the Medical
 Sectoral Annex to this Agreement.                  Devices Sectoral Annex to this
                                                    Agreement.
 For electromagnetic compatibility aspects, see the For electromagnetic compatibility aspects.
 Electromagnetic Compatibility (EMC) Sectoral       see the Electromagnetic Compatibility
 Annex to this Agreement.                           (EMC) Sectoral Annex to this Agreement.
 For telecommunications equipment, see the          For telecommunications equipment, see
 Telecommunications Equipment Sectoral Annex        the Telecommunications Equipment
 to this Agreement.                                 Sectoral Annex to this Agreement.
                                       40
                                          54                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electrical Safety Annex
                                     SECTION II
                              SCOPE AND COVERAGE
           EC                                          U.S.
 For U.S. access to the EC market:                  For EC access to the U.S. market:
 The electrical safety requirements of products The electrical safety requirements of
 falling under the scope of Council Directive   products falling under the scope of 29
 73/23/EEC on the harmonization of the laws     CFR 1910 subpart S. This includes the
 of the Member States relating to electrical '  electrical safety aspects for workplace
 equipment designed for use within certain      safety of medical equipment and
 voltage limits.                                telecommunication terminal equipment
                                                within the scope of those Sectoral
                                                Annexes.
                                                Products that are certified or approved
                                                under the Federal Mine Safety and Health
                                                Act (30 U.S.C. 801 et seq.^ or its
                                                regulations and used in areas under the
                                                authority of the Mine Safety and Health
                                                Administration, are not covered under
                                                this Annex.
                                         41
                                        55                   Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electrical Safety Annex
                                    SECTION III
        DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS
In accordance with the provisions of the Agreement, EC conformity assessment
bodies listed in Section V of this Annex shall be recognized to test, certify and mark
products within the scope of their NRTL recognition for assessing conformity to U.S.
requirements.
With regard to U.S. conformity assessment bodies listed in Section V of this Annex,
in the event of a challenge within the European Community under Article 8.2 of
Council Directive 73/23/EEC of 19 February 1973, test reports issued by such
conformity assessment bodies shall be accepted by the European Community
Authorities in the same way that reports from European Community Notified Bodies
are accepted. That is, (listed conformity assessment bodies) in the U.S. shall be
recognized under Article 11 of Council Directive 73/23/EEC as "bodies which may
make a report in accordance with Article 8."
                                        42
                                        56
                                                            Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Electrical Safety Annex
                                 SECTION IV
           AUTHORITIES RESPONSIBLE FOR DESIGNATING THE
        CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
        EC                                                                            U.S.
 For EC access to the U.S.                                               For U.S. access to the EC
 Market:                                                             market:
 Member States Authorities:
 Austria:                    Bundesministerium fur                    National Institute for Standards
                             wirtschaftiche Angelegenheiten           and Technology (NIST)
 Belgium:                    Ministere des Affaires
                             Economiques / Ministerie van
                             Economische Zaken
 Danmark:                    Elektricitetsraadet
 Finland:                    Ministry of Trade and Industry
 France: -              '    Ministere de l'^conomie, des
                             finances et de 1'Industrie
 Germany:                    Bundesmin. fur Arbeit und
                             Sozialordnung
 Greece:                     Ministry of Development
 Ireland:                    Department of EnterpriseTrade and
                             Employment
 Italy:                      Ministero dell' Industria
 Luxembourg:                 Service de l'Energie de l'Etat
 Netherlands:                Min van Economische Zaken
 Portugal:                   Istituto Portugues da Qualidade
 Spain:                      Ministerio de Industria y Energia
 Sweden:                     Styrelsen for Ackreditering och
                             Teknisk Kontroll
 U. K.                       Department of Trade & Industry
                                     43
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 ---pagebreak---       US - EC MRA Electrical Safety Annex
                                           SECTION V
                          CONFORMITY ASSESSMENT BODIES
                   EC                                             U.S.
For EC access to the U.S. market:                   For U.S. access to the EC market:
The names and scope of responsibilities of          The names and scope of responsibilities of
Conformity Assessment Bodies located in the EC      Conformity Assessment Bodies located in
and listed in accordance with this Sectoral Annex:  the U.S. and listed in accordance with this
                                                    Sectoral Annex:
     [** An initial list of Conformity Assessment Bodies should be listed in this
     Section by the time we implement the Agreement.**]
                                              44
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                                         SECTION VI
            DESIGNATING. LISTING. SUSPENDING AND WITHDRAWING
                          CONFORMITY ASSESSMENT BODIES
                         EC                                                U.S.
 For EC access to the US. market:                        For U.S. access to the EC market:
 Conformity assessment bodies from the EC shall Conformity assessment bodies from the
 be designated by the EC Authorities identified in U.S. shall be designated by the U.S.
 Section IV and recognized           by the Joint Authority identified in Section IV and
 Committee, in accordance with the recognition recognized by the Joint Committee, in
procedures in the Agreement and this Annex.         accordance         with      the     recognition
                                                    procedures in the Agreement and Council
Conformance with the appropriate ISO/IEC Guides Directive 73/23/EEC.
or the corresponding EN 4500 series of standards
shall be deemed consistent with U.S. requirements Conformance with the appropriate EN
identified in Section I.                            4500 series of standards or the
                                                    corresponding ISO/IEC Guides shall be
For purposes of designation and listing, EC deemed consistent with the requirements
Designating Authorities identified in Section IV of Council Directive 73/23/EEC.
shall designate conformity assessment bodies
located in the EC by filing a properly prepared
proposal for listing, which includes a complete lab For purposes of designating and listing, the
assessment under the U.S. OSHA procedures. U.S. Designating Authority identified in
OSHA shall notify the EC Designating Authority Section IV shall designate conformity
normally within 30 days as to whether the proposal assessment bodies located in the U.S. by
is complete or whether additional information is filing a properly prepared proposal for
required.                                           listing with the EC, which includes a
                                                    complete lab assessment under the
OSHA shall rely on the. EC Designating following EC or Member State procedures,
Authorities identified in Section IV for conducting as appropriate:
on-site reviews at the respective Member States'
conformity assessment bodies.                       The EC shall notify the U.S. Designating
                                                    Authority within 30 days as to whether the
                                                    proposal is complete and shall indicate,
                                                    where     applicable,         any     additional
                                                    information that is required.
                                            45
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                                     SFCT1QN VI f continued^
                          EC                                                  U.S.
Upon receipt of a complete proposal, the U.S.          Upon receipt of a complete proposal, the
exercising its authority under its law shall:          EC shall give notice of consent or
                                                       objection to the Joint Committee within 60
(a) prior to the passage from the transitional phase   days. The Joint Committee shall monitor
 into     the    operational      phase     in     the the recognition of conformity assessment
Telecommunications            Equipment           and  bodies and confirm such a recognition by
Electromagnetic Compatibility (EMC) Sectoral           listing them in Section V of this Sectoral
Annexes, give notice of its consent or objection to    Annex.
a proposed conformity assessment body to the Joint
Committee. The listing of an agreed conformity         The U.S. conformity assessment bodies
assessment body in Section V of this Sectoral          listed in Section V shall have Notified
Annex shall only occur upon such passage from the      Body status within the EC.
transitional phase into the operational phase of
those Sectoral Annexes.
(b) subsequent to passage from the transitional
phase into the operational phase in the
Telecommunications            Equipment           and
Electromagnetic Compatibility (EMC) Sectoral
Annexes, give notice of its consent or objection to
a proposed conformity assessment body to the Joint
Committee normally within 120 business days. The
listing of an agreed conformity assessment body in
Section V of this Sectoral Annex shall occur upon
notice of consent to the Joint Committee and the
Joint Committee's decision to list such body.
These listing procedures shall supersede the
procedures in Article 7(c) of the Agreement in its
entirety and the time periods set out in Article 7(d)
of the Agreement.
EC conformity assessment bodies listed in Section
V shall have NRTL status in the U.S.
                                               46
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                                   SECTION VI (continued^!
                          EC                                           U.S.
With regard to the suspension of a conformity
assessment body listed in this Sectoral Annex, the
period specified in Article 8(e) of the Agreement
shall begin to run after a Party has notified the
Joint Sectoral Committee or the Joint Committee,
pursuant to Article 8(c) of the Agreement, that it
proposes to revoke the conformity assessment
body's recognition in accordance with its
procedures under its applicable domestic law.
Except as provided for in this Section, procedures
for designation, listing, suspension and withdrawal
of conformity assessment bodies under this
Sectoral Annex shall be carried out in accordance
with Articles 7, 8 and 9 of the Agreement.
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                                    SECTION VII
      JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY
     The Joint Sectoral Committee for Electrical Safety (JCS/ES) consists of
     representatives of the U.S. and the EC. ÔSHA shall represent the U.S. on this
     Joint Sectoral Committee. The EC and OSHA may invite the participation of
     others as deemed necessary. Each Party shall have one vote and decisions shall
     be made by unanimous consent, unless otherwise specified herein. The Joint
     Sectoral Committee shall determine its own rules of procedure.
     The Joint Sectoral Committee may address any matter related to the effective
     functioning of this Sectoral Annex, including :
     - Developing improved procedures and criteria for designation in order to
        facilitate the assessment and preparation of proposals by Designating
        Authorities, with a view towards expediting the period between designation
        and listing;
     - providing a forum for discussion of issues that may arise concerning the
        implementation of this Sectoral Annex;
     - advising the Parties on matters relating to this Sectoral Annex; and
     - enhancing the operation of this Sectoral Annex.
                                        48
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                                   EC - U.S. MRA
                                  SECTORAL ANNEX
                                            FOR
                               RECREATIONAL CRAFT
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition
between the Unites States and the European Community.
The purpose of this Sectoral Annex is to establish aframeworkto accept certificates
of conformity issued in the territory of one Party in accordance with the regulatory
requirements of the other Party as referenced in this Sectoral Annex.
To facilitate that purpose, a transitional period of eighteen months is arranged to build
confidence as defined in this Sectoral Annex, Section 6.
                                           49
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                                     SECTION 1
         LEGISLATIVE. REGULATORY. AND ADMINISTRATIVE
                                 REQUIREMENTS
1.    For the European Community:
      European Parliament and European Council Directive 94/25 EEC on the
      Approximation of the Laws, Regulations, and Administrative Provisions of the
      Member States Relating to Recreational Craft.
2.    For the US,:
      46 U.S.C. Chapter 43, 33 CFR 81, 84, 159, 179, 181,183 and 46 CFR 58.
                                     SECTION 2
                            SCOPE AND COVERAGE
1.    This Sectoral Annex applies to all recreational craft which in the European
      Community or the United States are subject to conformity assessment by a
      conformity assessment body or an approval procedure, as applicable, before
      being put on the market.
2.    The product coverage for each Party shall be determined by the following
      relevant requirements:
      (a)     for the European Community:
              Recreational craft as defined in Directive 94/25 EEC.
      (b)     for the United States:
              Any product falling under the scope of 46 U.S.C. Chapter 43, 33 CFR
              81, 84, 159, 179, 181, 183 and 46 CFR 58.
                                         50
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      The Parties agree that for mutual recognition to operate under this Sectoral
      Annex, the following arrangements shall apply:
      (a)     for approvals to European Community requirements, conformity
              assessment bodies designated by the U.S. shall establish compliance as
              required to be demonstrated by Directive 94/25 EEC. This
              demonstration of compliance shall be recognized in the European
              Community and products so certified shall have unrestricted access to
              the EC market for sale as recreational craft, pursuant to Section 1.
      (b)     for approvals to United States requirements, conformity assessment
              bodies designated by the European Community shall establish
              compliance as required to be demonstrated as set forth in paragraph
              2(b) of this Section and products so certified shall have unrestricted
              access to the U.S. market for sale as recreational craft, pursuant to
              Section 1.
                                    SECTION 3
            AUTHORITIES RESPONSIBLE FOR DESIGNATING
                 THE CONFORMITY ASSESSMENT BODIES
1.    For the European Community:
      Member States Administrations as indicated in the Directive 94/25 EEC,
      Article 9.1.
2.    For the United States:
      National Institute of Standards and Technology (NI ST).
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                                       SECTION 4
       DESIGNATING. LISTING. SUSPENDING AND WITHDRAWING
                      CONFORMITY ASSESSMENT BODIES
 1.     For the purpose of this Sectoral Annex, each party shall designate competent
        conformity assessment bodies to carry out conformity assessment and
        approval to the requirements of the other Party. Such designation shall be
        carried out according to the procedures set out in Article 7 of the Agreement.
        A list of conformity assessment bodies together with the products and
        procedures for which they have been listed, is in Section 5 below.
2.      Each Party agrees that the listed conformity assessment bodies comply with
        the requirements for such bodies established by the other Party. These are:
       (a)      for the European Community, bodies which are Notified Bodies in
                accordance with Directive 94/25 EEC, are deemed to be in compliance
                with U.S. requirements;
       (b)      for the U.S., in accordance with the requirements set out in the
               regulations listed in Section 1, the conformity assessment bodies listed
               in Section 5 are designated by NIST using the evaluation procedures
               contained in the appropriate EN 45000 series of standards or the
               corresponding ISO/IEC Guides.
3.     With regard to the designation, listing, suspension and withdrawal of
       conformity assessment bodies under this Sectoral Annex, the specific
       procedures in Articles 7, 8 and 9 of the Agreement shall be followed.
                                      SECTIONS
                      CONFORMITY ASSESSMENT BODIES
       European Community
       The conformity assessment bodies designated by the European Community are
       those Notified Bodies which have been notified by the Member States of the
       Community, in accordance with Directive 94/25 EEC, and whose names and
       reference numbers have been published in the Official Journal of the European
       Communities.
                                          52
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2.      United States
        [To be provided by U.S.]
                                       SECTION 6
                         TRANSITIONAL ARRANGEMENT
 1.    There shall be a transitional period of 18 months prior to the operations of this
       Sectoral Annex.
2.     The purpose of the transitional arrangement is to provide a means whereby the
       Parties to this Agreement can cooperate to establish a system for designating
       conformity assessment bodies and can mutually build confidence in the
       abilities of these bodies.        Successful completion of this transitional
       arrangement is intended to result in a determination that conformity
       assessment bodies comply with the applicable criteria and to have the
       equipment approved by the conformity assessment bodies of the exporting
       country accepted by the approval authority of the importing country
3.     During this transitional period, the parties shall:
       (a)      exchange information on technical data and conformity assessment
                criteria and procedures, thus developing greater familiarity with their
                respective regulatory requirements; and
       (b)      carry out or recommend any applicable policy, legislative and
                regulatory changes necessary for the provisions of this Annex.
4.     Product Scope
       All products covered by Section 2 of this Annex.
5.     Cooperation
       During this transitional period, both Parties shall endeavor to jointly sponsor
       seminars for the purpose of improving the understanding of technical
       specifications applicable in each Party's jurisdiction.
6.     Inspections
       Inspections or audits shall be permitted to verify compliance of conformity
       assessment bodies with their responsibilities under this Agreement. The scope
       of these inspections or audits shall be agreed upon in advance by both Parties.
                                          53
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                                        SECTION 7
                             ADDITIONAL PROVISIONS
 1.     In accordance with the relevant provisions of the Agreement, the Parties shall
        ensure the continued availability of the names of their respective notified
        bodies or conformity assessment bodies, and shall regularly supply details of
        certifications issued in order to facilitate post market surveillance.
2.      The Parties note that, to the extent that requirements for electrical safety or
        electromagnetic compatibility may apply to products covered by this Sectoral
        Annex, the provisions of the Sectoral Annexes on Electrical Safety and
        Electromagnetic Compatibility apply.
                                       SECTION 8
                                     DEFINITIONS
Notified Body means a third party authorized to perform the conformity assessment
tasks specified in Directive 94/25 EEC, which has been appointed by a Member State
from the bodies falling within its jurisdiction. The Notified Body has the necessary
qualifications to meet requirements laid down in Directive 94/25 EEC and has been
notified to the Commission and to the other Member States.
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 ---pagebreak--- US - EC MRA Pharmaceutical Good Manufacturing Practices Annex
                                     EC-U.S. MRA
                                SECTORAL ANNEX
                                         FOR
           PHARMACEUTICAL GOOD MANUFACTURING PRACTICES
                                        (GMPs)
 PREAMBLE
 Recognizing that this Annex constitutes a Sectoral Annex to the framework
 Agreement on Mutual Recognition between the United States and the European
 Community.
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                                       CHAPTER 1
                 DEFINITIONS, PURPOSE, SCOPE AND COVERAGE
                                         Article 1
                                        Definitions
  1. "Equivalence " of the regulatory systems means that the systems are sufficiently
     comparable to assure that the process of inspection and the ensuing inspection
     reports will provide adequate information to determine whether respective
     statutory and regulatory requirements of the authorities have been fulfilled.
     "Equivalence" does not require that the respective regulatory systems have
     identical procedures.
  2. "Enforcement" means action taken by an authority to protect the public from
     products of suspect quality, safety and efficacy or to assure that products are
     manufactured in compliance with appropriate laws, regulations, standards and
     commitments made as part of the approval to market a product.
  3. "Good Manufacturing Practices " ^tentative merging of US and EC concepts to
     be revisited)
     GMPs mean the requirements found in the respective legislations, regulations,
     and administrative provisions for methods to be used in, and the facilities or
     controls to be used for, the manufacturing, processing, packing, and/or holding
     of a drug to assure that such drug meets the requirements as to safety, and' has
     the identity and strength, and meets the quality and purity characteristics that it
     purports or is represented to process.
     GMPs are that part of quality assurance which ensures that products are
     consistently produced and controlled to quality standards. For the purpose of
     this Annex, GMPs include therefore the system whereby the manufacturer
     receives the specifications of the product and/or process from the Marketing
     Authorization/Product Authorization or License holder or applicant and ensures
     the product is made in compliance with its specifications (Qualified Person
     certification in the EC).
  4. "Inspection" means an on-site evaluation of a manufacturing facility to
     determine whether such manufacturing facility is operating in compliance with
     Good Manufacturing Practices and/or commitments made as part of the approval
     to market a product.
  5. "Inspection Report" means the written observations and Good Manufacturing
      Practices compliance assessment completed by an authority listed in
      Appendix 2.
  6. "Regulatory System" means the body of legal requirements for Good
      Manufacturing Practices, inspections, and enforcements that ensure public health
      protection and legal authority to assure adherence to these requirements.
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                                         Article 2
                                         Purpose
  The provisions of this Annex govern the exchange between the Parties and normal
  endorsement by the receiving authority of official Good Manufacturing Practices
  (GMP) inspection reports after a transitional period aimed at determination of the
 equivalence of the regulatory systems of the Parties, which is the cornerstone of
 this Annex.
                                         Article 3
                                          Scope
  The provisions of this Annex shall apply to pharmaceutical inspections carried out
  in the United States and Member States of the European Community before
  products are marketed (hereafter referred to as "pre-approval inspections") as well
  as during their marketing (hereafter referred to as "post-approval inspections").
 Appendix 1 names the laws, regulations and administrative provisions governing
 these inspections and the GMP requirements.
 Appendix 2 lists the authorities participating in activities under this Annex.
 Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex.
                                        Article 4
                                    Product coverage
 These provisions will apply to medicinal products for human or animal use,
 intermediates and starting materials (as referred to in the EU) and to drugs for
 human or animal use, biological products for human use, and active pharmaceutical
 ingredients (as referred to in the United States), only to the extent they are
 regulated by the authorities of both Parties as listed in Appendix 2.
 Human blood, human plasma, human tissues and organs, and veterinary
 immunologicals are excluded from the scope of this Annex. Human plasma
 derivatives (such as immunoglobulins and albumin), investigational medicinal
 products/new drugs, human radiopharmaceuticals and medicinal gases are also
 excluded during the transition phase, their situation will be reconsidered at the end
 of the transition period. Products regulated by the Center for Biologies Evaluation
 and Research as devices are not covered under this Annex.
 Appendix 3 contains an indicative list of products covered by this Annex.
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                                      CHAPTER 2
                                 TRANSITION PERIOD
                                        Article 5
                                Length of transition period
  A three-year transition period will start immediately after the effective date of the
  Agreement.
                                        Article 6
                                 Equivalence assessment
  1. The criteria to be used by the Parties to assess equivalence are listed in
     Appendix 4. Information pertaining to the criteria under Community
     competence will be provided by the Community.
 2. The authorities of the parties will establish and communicate to each other their
     draft programs for assessing the equivalence of the respective regulatory
     systems in terms of quality assurance of the products and consumer protection.
     These programs will be carried out, as deemed necessary by the authorities, for
     post- and pre-approval inspections and for various product classes or processes.
 3. The equivalence assessment shall include information exchanges (including
     inspection reports), joint training, and joint inspections for the purpose of
     assessing regulatory systems and the authorities' capabilities. In conducting the
     equivalence assessment, the Parties will ensure that efforts are made to save
     resources.
 4. Equivalence assessment for authorities added to Appendix 2 after the effective
     date of this agreement will be conducted as described in this Annex, as soon as
     practicable.
                                        Article 7
             Participation in the equivalence assessment and determination
 The authorities listed in Appendix 2 will actively participate in these programs to
 build a sufficient body of evidence for their equivalence determination. Both parties
 will exercise good faith efforts to complete equivalence assessment as
 expeditiously as possible to the extent the resources of the authorities allow.
                                        Article 8
                                Other transition activities
 As soon as possible, the authorities will jointly determine the essential information
 which must be present in inspection reports and will cooperate to develop mutually
 agreed inspection report format(s).
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                                       CHAPTER 3
                             END OF TRANSITION PERIOD
                                          Article 9
                                Equivalence determination
  Equivalence is established by having in place regulatory systems covering the
  criteria referred to in Appendix 4, and a demonstrated pattern of consistent
  performance in accordance with these criteria. A list of authorities determined as
  equivalent shall be agreed to by the Joint Sectoral Committee at the end of the
  transition period, with reference to any limitation in terms of inspection type (e.g.
  post-approval or pre-approval) or product classes or processes.
  The Parties will document insufficient evidence of equivalence, lack of opportunity
  to assess equivalence or a determination of non-equivalence, in sufficient detail to
  allow the authority being assessed to know how to attain equivalence.
                                         Article 10
                      Authorities not listed as currently equivalent
  Authorities not currently listed as equivalent, or not equivalent for certain types of
  inspections, product classes or processes may apply for reconsideration of their
  status once the necessary corrective measures have been taken or additional
 experience is gained.
                                       CHAPTER 4
                                 OPERATIONAL PERIOD
                                         Article 11
                              Start of the operational period
 The operational period shall start at the end of the transition period and its
 provisions apply to inspection reports generated by authorities listed as equivalent
  for the inspections performed in their territory.
  In addition, when an authority is not listed as equivalent based on adequate
 experience gained during the transition period, the FDA will accept for normal
 endorsement (as provided in Article 12) inspection reports generated as a result of
  inspections conducted jointly by that authority on its territory and another authority
  listed as equivalent, provided that the authority of the Member State in which the
  inspection is performed can guarantee enforcement of the findings of the inspection
  report and require that corrective measures be taken when necessary. FDA has the
  option to participate in these inspections, and based on experience gained during
  the transition period, the Parties will agree on procedures for exercising this option.
                                           59
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 ---pagebreak--- US - EC MRA Pharmaceutical Good Manufacturing Practices Annex
  In the EC, the qualified person will be relieved of responsibility for carrying the
  controls laid down in Article 22 paragraph 1(b) of Council Directive 75/319/EEC
  provided that these controls have been carried out in the United States and that each
  batch/lot is accompanied by a batch certificate (in accordance with the WHO
  certification scheme on the quality of medicinal products) issued by the
  manufacturer certifying that the product complies with requirements of the
  marketing authorization and signed by the person responsible for releasing the
  batch/lot.
                                        Article 12
                       Nature of recognition of inspection reports
  Inspection reports (containing information as established under Article 8),
  including a GMP compliance assessment, prepared by authorities listed as
  equivalent, will be provided to the authority of the importing Party. Based on the
  determination of equivalence in light of the experience gained, these inspection
  reports will normally be endorsed by the authority of the importing Party, except
  under specific and delineated circumstances. Examples of such circumstances
  include indications of material inconsistencies or inadequacies in an inspection
  report, quality defects identified in the post-market surveillance or other specific
  evidence of serious concern in relation to product quality or.consumer safety. In
  such cases, the authority of the importing Party may request clarification from the
  authority of the exporting Party which may lead to a request for re-inspection. The
  authorities will endeavor to respond to requests for clarification in a timely manner.
  Where divergence is not clarified in this process, an authority of the importing
  country may carry out an inspection of the production facility.
                                        Article 13
                    Transmission of post-approval inspection reports
  Post-approval GMP inspection reports concerning products covered by this Annex
  will be transmitted to the authority of the importing country within 60 calendar
  days of the request. Should a new inspection be needed, the inspection report will
  be transmitted 90 calendar days of the request.
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                                        Article 14
                    Transmission ofpre-approval inspection reports
  A preliminary notification that an inspection may have to take place will be made
  as soon as possible.
  Within 15 calendar days, the relevant authority will acknowledge receipt of the
  request and confirm its ability to carry out the inspection. In the EC, requests will
 be sent directly to the relevant authority, with a copy to the European Agency for
 the Evaluation of Medicinal Products (EMEA). If the authority receiving the
 request cannot carry out the inspection as requested, the requesting authority shall
 have the right to conduct the inspection.
  Reports of pre-approval inspections will be sent within 45 calendar days of the
 request that transmitted the appropriate information and detailed the precise issues
 to be addressed during the inspection. A shorter time may be necessary in
 exceptional cases and these will be described in the request.
                                       Article 15
                           Monitoring continued equivalence
 Monitoring activities for the purpose of maintaining equivalence shall include
 review of the exchange of inspection reports and their quality and timeliness;
 performance of a limited number of joint inspections; and the conduct of common
 training sessions.
                                       Article 16
                                       Suspension
 Each Party has the right to contest the equivalence of an authority. This right will
 be exercised in an objective and reasoned manner in writing to the other Party.
 The issue shall be discussed in the Joint Sectoral Committee promptly upon such
 notification. Where the JSC determines that verification of equivalence is required,
 it may be carried out jointly by the Parties in a timely manner, pursuant to
 Article 6.
 Efforts will be made by the Joint Sectoral Committee to reach unanimous consent
 on the appropriate action. If agreement to suspend is reached in the Joint Sectoral
 Committee, an authority may be suspended immediately thereafter. If no agreement
 is reached in the Joint Sectoral Committee, the matter is referred to the Joint
 Committee. If no unanimous consent is reached within 30 days after such
 notification, the contested authority will be suspended.
 Upon the suspension of an authority previously listed as equivalent, a Party is no
 longer obligated to normally endorse the inspection reports of the suspended
 authority. A Party shall continue to normally endorse the inspection reports of that
 authority prior to suspension, unless the authority of the receiving party decides
 otherwise based on health or safety considerations. The suspension will remain in
 effect until unanimous consent has been reached by the Parties on the future status
 of that authority.
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                                       CHAPTERS
                           JOINT SECTORAL COMMITTEE
                                         Article 17
                   Role and composition of the Joint Sectoral Committee
  A Joint Sectoral Committee is set up to monitor the activities under both the
  transitional and operational phases of this Annex.
  The Committee will be co-chaired by a representative of FDA for the US and a
  representative of the EC who each will have one vote. Decisions will be taken by
  unanimous consent.
  The Joint Sectoral Committee's functions will include:
  1. making a joint assessment, which must be agreed by both Parties, of the
     equivalence of the respective authorities,
  2. developing and maintaining the list of equivalent authorities, including any
      limitation in terms of inspecting type or products, and communicating the list to
     all authorities and the Joint Committee,
  3. providing a forum to discuss issues relating to this Annex, including concerns
     that an authority may be no longer equivalent and opportunity to review product
     coverage,
 4. consideration of the issue of suspension.
 The Joint Sectoral Committee shall meet at the request of either Party and, unless
 the co-chairs otherwise agree, at least once each year. The Joint Committee will be
  kept informed of the agenda and conclusions of meetings of the Joint Sectoral
 Committee.
                                       CHAPTER 6
                              INFORMATION EXCHANGE
                                         Article 18
                                 Regulatory collaboration
 The Parties and authorities shall inform and consult one another, as permitted by
  law, on proposals to introduce new controls or to change existing technical
  regulations or inspection procedures and to provide the opportunity to comment on
  such proposals.
  The Parties shall notify each other in writing of any changes to Appendix 2.
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                                        Articled
                         Information relating to quality aspects
  The authorities will establish an appropriate means of exchanging information on
  any confirmed problem reports, corrective actions, recalls, rejected import
 consignments and other regulatory and enforcement problems for products subject
  to this Annex.
                                       Article 20
                                      Alert System
 The details of an alert system will be developed during the transitional period. The
  system will be maintained in place at all times. Elements to be considered in
 developing such a system are described in Appendix 5.
 Contact points will be agreed between both Parties to permit authorities to be made
 aware with the appropriate speed in case of quality defect, recalls, counterfeiting
 and other problems concerning quality, which could necessitate additional controls
 or suspension of the distribution of the product.
                                     CHAPTER 7
                                SAFEGUARD CLAUSE
                                       Article 21
 Each Party recognizes that the importing country has a right to fulfill its legal
 responsibilities by taking actions necessary to ensure the protection of human and
 animal health at the level of protection it deems appropriate. This includes the
 suspension of the distribution, product detention at the border of the importing
 country, withdrawal of the batches and any request for additional information or
 inspection as provided in Article 12.
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                                   APPENDIX 1
         List of applicable laws, regulations and administrative provisions
  For the European Community:
  Council Directive 65/65/EEC of 26 January 1965 on the approximation of
 provisions laid down by law, regulation or administrative action relating to
 proprietary medicinal products as extended, widened and amended.
 Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions
  laid down by law, regulation or administrative action relating to proprietary
 medicinal products as extended, widened and amended.
 Council Directive 81/851/EEC of 6 November 1981 on the approximation of the
 laws of the Member States relating to veterinary medicinal products as widened and
 amended.
 Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and
 guidelines of good manufacturing practice for medicinal products for human use
 Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and
 guidelines of good manufacturing practice for veterinary medicinal products
 Council Regulation No (EEC) 2309/93 of 23 July 1993 laying down Community
 procedures for the authorization and supervision of medicinal products for human
 and veterinary use and establishing a European Agency for the Evaluation of
 Medicinal Products
 Council Directive 25/92/EEC of 31 March 1992 on the wholesale distribution of
 medicinal products for human use & Guide to Good Distribution Practice
 Current version of the Guide to Good Manufacturing Practice, Rules Governing
 Medicinal Products in the European Community, Volume IV.
 For the United States :
 Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and
 the United States Public Health Service Act
 Relevant sections of Title 21, United States Code of Federal Regulations (CFR)
 Parts 1-99, Parts 200-299, Parts 500-599, and Parts 600-799
 Relevant sections of the FDA Investigations Operations Manual, the FDA
 Regulatory Procedures Manual, the FDA Compliance Policy Guidance Manual, the
 FDA Compliance Program Guidance Manual, and other FDA guidances.
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                                         APPENDIX 2
                                       list of Authorities
  United States
  In the United States, the regulatory authority is the Food and Drug Administration.
  European Community
  In the European Community, the regulatory authorities are the following:
  Austria:            Bundesministerium fur Arbeit, Gesundheit und Soziales, Wien
  Belgium:            Ministerie van Sociale Zaken, Volksgezondheid en
                      Leefmilieu/Ministère des Affaires Sociales, Santé Publique et
                      Environnement/Algemene Farmaceutische Inspectie, Inspection
                      Générale de la Pharmacie, Brussel, Bruxelles
  Denmark:            Lasgemiddelstyrelsen, Danish Medicines Agency, Bronshoj
  Finland:            Lââkelaitos/Lâkemedelsverket (National Agency for Medicines),
                      Helsinki
                      Agence du Médicament, Direction de l'inspection et des
  France:            établissements, Saint Denis (Human)
                      Agence Nationale du Médicament Vétérinaire, Fougères (Veterinary)
                      Bundesgesundheitsministerium, Bonn
  Germany:            Paul-Ehrlich Institut, Langen (biologicals only)
                     Zustandige Behôrden der 16 Bundeslânder: Bayern, Berlin,
                      Brandenburg, Bremen, Hamburg, Hessen, Niedersachsen, Nordrhein-
                      Westfalen, Rheinland-Pfalz, Mecklenburg-Vorpommern, Saarland,
                      Sachsen, Sachsenanhalt, Schleswig-Holstein, Thuringen
  Greece:             Ministry of Health and Welfare, National Drug Organisation (E.O.F.),
                      Athens
  Ireland:            Irish Medicines Board, Dublin
  Italy:              Ministero délia Sanità, Dipartimento Farmaci e Farmacovigilanza,
                      Roma - (Human)
                      Ministero délia Sanità, Dipartimento alimenti e nutrizione e sanità
                     pubblica veterinaria - Div. IX, Roma - (Veterinary)
  Luxembourg:         Direction de la Santé, Division de la Pharmacie et des Médicaments,
                      Luxembourg
  The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie voor de
                      Gezondheidszorg, Rijswijk
  Portugal:           Instituto da Farmàcia e do Medicamento (INFARMED), Lisboa
  Spain:              Ministerio Sanidad y Consumo, Subdirecciôn. General de Control
                      Farmacéutico, Madrid (Human)
                      Ministerio de Agricultura Pesca y Alimentaciôn, Madrid, (Veterinary)
  Sweden:             Lâkemedelsverket ( Medical Products Agency), Uppsala
  United Kingdom: Medicines Control Agency, London
                      Veterinary Medicines Directorate, Addlestone
  European Union: European Commission, Brussels
                      European Agency for the Evaluation of Medicinal Products (EMEA)
                                             65
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                                    APPENDIX 3
              Indicative list of Products covered by the Sectoral Annex
 Recognizing that precise definition of medicinal products and drugs are to be found
  in the legislations referred to above, an indicative list of products covered by the
 agreement is given below:
 - human medicinal products including prescription and non-prescription drugs;
 - human biologicals including vaccines, and immunologicals;
 - veterinary pharmaceuticals, including prescription and non-prescription drugs,
     with the exclusion of veterinary immunologicals;
 - pre-mixes for the preparation of veterinary medicated feeds (EC), Type A
     medicated articles for the preparation of veterinary medicated feeds (US);
 - intermediate products and active pharmaceutical ingredients or bulk
     pharmaceuticals (US) / starting materials (EC).
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                                    APPENDIX 4
          Criteria for Assessing Equivalence for Post- and Pre-Approval
  I.  Legal / Regulatory authority and structures and procedures providing for post-
      and pre-approval:
      A. Appropriate statutory mandate and jurisdiction.
      B. Ability to issue and update binding requirements on GMPs and guidance
          documents.
      C. Authority to make inspections, review and copy documents, and to take
          samples and collect other evidence.
      D. Ability to enforce requirements and to remove products found in violation
          of such requirements from the market.
      E. Substantive current good manufacturing requirements
      F. Accountability of the regulatory authority.
      G. Inventory of current products and manufacturers.
      H. System for maintaining or accessing inspection reports, samples and other
          analytical data, and other firm/product information relating to matters
          covered by this Sectoral Annex.
  II. Mechanisms in place to assure appropriate professional standards and
      avoidance of conflicts of interest.
 III. Administration of the regulatory authority:
      A. Standards of education/qualification and training.
      B. Effective quality assurance systems measures to ensure adequate job
          performance.
      C. Appropriate staffing and resources to enforce laws and regulations.
 IV. Conduct of Inspections:
      A. Adequate preinspection preparation, including appropriate expertise of
          investigator / team, review offirm/ product and databases, and availability
          of appropriate inspection equipment.
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      B. Adequate conduct of inspection, including statutory access to facilities,
           effective response to refusals, depth and competence of evaluation of
           operations, systems, and documentation; collection of evidence;
           appropriate duration of inspection and completeness of written report of
           observations tofirmmanagement.
      C. Adequate post-inspection activities, including completeness of inspectors'
           report, inspection report review where appropriate, and conduct of follow-
           up inspections and other activities where appropriate, assurance of
          preservation and retrieval of records.
 V. Execution of regulatory enforcement actions to achieve corrections, designed
      to prevent future violations, and to remove products found in violation of
      requirements from the market.
  VI. Effective Use of Surveillance Systems:
      A.  Sampling and analysis
      B.  Recall monitoring
      C.  Product defect reporting system
      D.  Routine surveillance inspections
      E.  Verification of approved manufacturing process changes to marketing
          authorizations / approved applications
 VII. Additional specific criteria for pre-approval inspections
      A. Satisfactory demonstration through a jointly developed and administered
          training program and joint inspections to assess the authorities'
          capabilities.
      B. Pre-inspection preparation includes the review of appropriate records,
          including site plans and drug master file or similar documentation to
          enable adequate inspections.
      C. Ability to verify chemistry, manufacturing and control data supporting an
          application is authentic and complete.
      D. Ability to assess and evaluate research and development data as
          scientifically sound, especially transfer technology of pilot, scale up and
          full scale production batches.
      E. Ability to verify conformity of the on site processes and procedures with
          those described in the application.
      F. Review and evaluate equipment installation, operational and performance
          qualification data, and evaluate test method validation.
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                                    APPENDIX 5
         Elements to be Considered in Developing a Two-wav Alert System
  1. Documentation
      - Definition of a crisis/emergency and under what circumstances an alert is
        required
      - Standard Operating Procedures (SOPs)
      - Mechanism of health hazards evaluation and classification
      - Language of communication and transmission of information
 2. Crisis Management System
     -  Crisis analysis and communication mechanisms
     -  Establishment of contact points
     -  Reporting mechanisms          «.
 3. Enforcement Procedures
     -  Follow-up mechanisms
     -  Corrective action procedures
 4. Quality Assurance System
     -  Pharmacovigilance programme
     -  Surveillance/monitoring of implementation of corrective action
 5. Contact points
     For the purpose of this agreement, the contact points for the alert system will be:
    for the European Community,
         the Executive Director of the European Agency for the Evaluation of
         Medicinal Products, 7, Westferry Circus, Canary Wharf, UK -
         London El4 4HB, England. Telephone +44-171-418 8400, Fax 418
         8416.
    for the United States:
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 ---pagebreak---  US - EC MRA Medical Devices Annex
                                    EU - U.S. MRA
                             SECTORAL ANNEX ON
                               MEDICAL DEVICES
PREAMBLE
Recognizing that this Annex constitutes a Sectoral Annex to the Agreement on Mutual
Recognition in Relation to Conformity Assessment (Agreement) between the United
States (U.S.) and the European Community (EC),
Acknowledging that carrying out the provisions of this Annex will further public
health protection, will be an important means of facilitating commerce in medical
devices, and will lead to reduced costs for regulators and manufacturers of both
Parties,
The Parties agree as follows:
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                                    CHAPTER 1
      PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX
                                       Article 1
                                       Purpose
1. The purpose of this Annex is to specify the conditions under which a Party will
   accept the results of quality system-related evaluations and inspections and
   premarket evaluations of the other Party with regard to medical devices as
   conducted by listed conformity assessment bodies (CABs) and to provide for other
   related cooperative activities.
2. This Annex is intended to evolve as programs and policies of the Parties evolve.
   The Parties will review this Annex periodically, in order to assess progress and
   identify potential enhancements to this Annex as FDA and EC policies evolve over
   time.
                                       Article 2
                                        Scope
1. The provisions of this Annex shall apply to the exchange and, where appropriate,
   endorsement of the following types of reports from CABs assessed to be
   equivalent:
        a. Under the U.S. system, surveillance/post-market and initial/pre-approval inspection
           reports;
        b. Under the U.S. system, premarket (510(k)) product evaluation reports;
        c. Under the EC system, quality system evaluation reports; and
        d. Under the EC system, EC type examination and verification reports.
   Appendix 1 names the legislation, regulations, and related procedures under which:
   (a) products are regulated as medical devices by each Party; (b) CABs are
   designated and confirmed; and (c) these reports are prepared.
2. For purposes of this Annex, equivalence means that: CABs in the EC are capable
   of conducting product and quality systems evaluations against U.S. regulatory
   requirements in a manner equivalent to those conducted by FDA; and CABs in the
   U.S. are capable of conducting product and quality systems evaluations against EC
   regulatory requirements in a manner equivalent to those conducted by EC CABs.
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                                          Article 3
                                     Product Coverage
 There are three components to this agreement each covering a discrete range of
 products:
 1. Quality System Evaluations - U.S.-type surveillance/post-market and initial/pre-approval
     inspection reports and EC-type quality system evaluation reports will be exchanged with
     regard to all products regulated under both U.S. and EC law as medical devices.
 2. Product Evaluation - U.S.-type premarket (510(k)) product evaluation reports and EC-
     type-testing reports will be exchanged only with regard to those products classified under
     the U.S. system as Class I/CIass II - Tier 2 medical devices which are listed in Appendix 2.
 3. Post-Market Vigilance Reports - Post-market vigilance reports will be exchanged with
    regard to all products regulated under both U.S. and EC law as medical devices.
 Additional products and procedures may be made subject to this Annex by agreement
 of the Parties. >
                                          Article 4
                                  Regulatory A uthorities
The regulatory authorities shall have the responsibility of implementing the provisions
of this Annex, including the designation and monitoring of CABs. Regulatory
authorities are specified in Appendix 3. Each Party will promptly notify the other
Party in writing of any change in the regulatory authority for a country.
                                       CHAPTER 2
                                 TRANSITION PERIOD
                                         Article 5
                         Length and purpose of transition period
There will be a three-year transition period immediately following the date of entry
into force of the Agreement. During the transition period, the Parties will engage in
confidence-building activities for the purpose of obtaining sufficient evidence to make
determinations concerning the equivalence of CABs of the other Party with respect to
the ability to perform quality system and product evaluations or other reviews
resulting in reports to be exchanged under this Annex.
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                                         Article 6
                                     Listing of CABs
Each Party shall designate CABs to participate in confidence-building activities by
transmitting to the other Party a list of CABs which meet the criteria for technical
competence and independence, as identified in Appendix 1. The list shall be
accompanied by supporting evidence. Designated CABs will be listed in Appendix 4
for participation in the confidence building activities once confirmed by the importing
Party. Non-confirmation would have to be justified based on documented evidence.
                                         Article 7
                             Confidence Building Activities
1. At the beginning of the transitional period, the Joint Sectoral Group will establish a
   joint confidence building program calculated to provide sufficient evidence of the
   capabilities of the designated CABs to perform quality system or product
   evaluations to the specifications of the Parties.
2. The joint confidence building program should include the following actions and
   activities:
        a. Seminars designed to inform the Parties and CABs about each Party ' s regulatory
            system, procedures, and requirements;
        b. Workshops designed to provide the Parties with information regarding
            requirements and procedures for the designation and surveillance of CABs;
        c. Exchange of information about reports prepared during the transition period;
        d. Joint training exercises; and
        e. Observed inspections.
3. During the transition period, any significant problem that is identified with a CAB
   may be the subject of cooperative activities, as resources allow and as agreed to by
   the regulatory authorities, aimed at resolving the problem.
4. Both Parties will exercise good faith efforts to complete the confidence building
   activities as expeditiously as possible to the extent that the resources of the Parties
   allow.
5. Both the EC and the U.S. will each prepare annual progress reports which will
   describe the confidence building activities undertaken during each year of the
   transition period. The form and content of the reports will be determined by the
   Parties through the Joint Sectoral Committee.
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                                           Article 8
                             Other transition period activities
 1. During the transition period, the Parties will jointly determine the necessary
     information which must be present in quality system and product evaluation
    reports.
2. The Parties will jointly develop a notification and alert system to be used in case of
    defects, recalls, and other problems concerning product quality that could
    necessitate additional actions (e.g., inspections by the Parties of the importing
   .country) or suspension of the distribution of the product.
                                       CHAPTER 3
                            END OF TRANSITION PERIOD
                                          Article 9
                                 Equivalence Assessment
1. In the final six months of the transition period, the Parties shall proceed to a joint
    assessment of the equivalence of the CABs that participated in the confidence
    building activities. CABs will be determined to be equivalent provided they have
    demonstrated proficiency through the submission of a sufficient number of
    adequate reports. CABs may be determined to be equivalent with regard to the
    ability to perform any type of quality system or product evaluation covered by this
    Annex and with regard to any type of product covered by this Annex. The parties
    shall develop a list contained in Appendix 5 of CABs determined to be equivalent
    which shall contain a full explanation of the scope of the equivalency
    determination, including any appropriate limitations, with regard to performing any
    type of quality system or product evaluation.
2. The Parties shall allow CABs not listed for participation in the MRA, or listed for
    participation only as to certain types of evaluations, to apply for participation in
    this MRA once the necessary measures have been taken or sufficient experience
    has been gained, in accordance with Article 18.
3. Decisions concerning the equivalence of CABs must be agreed to by both Parties.
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                                        CHAPTER 4
                                OPERATIONAL PERIOD
                                          Article 10
                              Start of the operational period
1. The operational period will start at the end of the transition period after the Parties
   have developed the list of CABs found to be equivalent. The provisions of this
   Chapter will apply only with regard to listed CABs and only to the extent of any
   specifications and limitations contained on the list with regard to a CAB.
2. The operational period will apply to quality system evaluation reports and product
   evaluation reports generated by CABs listed in accordance with this Annex for the
   evaluations performed in the respective territories of the Parties, except if the
   Parties agree otherwise.
                                          Article 11
           Exchange and endorsement of quality system evaluation reports
1. Listed EC CABs will provide FDA with reports of quality system evaluations, as
   follows:
        a. For pre-approval quality system evaluations, EC CABs will provide full répons;
           and
        b. For surveillance quality system evaluations, EC CABs will provide abbreviated
           reports.
2. Listed U.S. CABs will provide to the EC Notified Body of the manufacturer's
   choice:
        a. Full reports of initial quality system evaluations;
        b. Abbreviated reports of quality systems surveillance audits.
3. If the abbreviated reports do not provide sufficient information, the importing Party
   may request additional clarification from the CAB.
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   Based on the determination of equivalence in light of the experience gained, the
   quality system evaluation reports prepared by the CABs listed as equivalent will
   normally be endorsed by the importing Party, except under specific and delineated
   circumstances. Examples of such circumstances include indications of material
   inconsistencies or inadequacies in a report, quality defects identified in post-market
   surveillance or other specific evidence of serious concern in relation to product
   quality or consumer safety. In such cases, the importing Party may request
   clarification from the exporting Party which may lead to a request for re-inspection.
   The Parties will endeavor to respond to requests for clarification in a timely
   manner. Where divergence is not clarified in this process, the importing Party may
   carry out the quality system evaluation.
                                       Article 12
               Exchange and endorsement ofproduct evaluation reports
1. EC CABs listed for this purpose will, subject to the specifications and limitations
   on the list, provide to the FDA 510(k) premarket notification assessment reports
   prepared to U.S. medical device requirements.
2. U.S. CABs will, subject to the specifications and limitations on the list, provide to
   the EC notified body of the manufacturer's choice, type examination and
   verification reports prepared to EC medical device requirements.
3. Based on the determination of equivalence in light of the experience gained, the
   product evaluation reports prepared by the CABs listed as equivalent will normally
   be endorsed by the importing Party, except under specific and delineated
   circumstances. Examples of such circumstances include indications of material
   inconsistencies, inadequacies, or incompleteness in a product evaluation report, or
   other specific evidence of serious concern in relation to product safety,
   performance, or quality. In such cases, the importing Party may request
   clarification from the exporting Party which may lead to a request for a re-
   evaluation. The parties will endeavor to respond to requests for clarification in a
   timely manner. Endorsement remains the responsibility of the importing Party.
                                       Article 13
                   Transmission of quality system evaluation reports
Quality system evaluation reports covered by Article 11 concerning products covered
by this Annex shall be transmitted to the importing Party within 60 calendar days of a
request by the importing Party. Should a new inspection be requested the time period
shall be extended by an additional 30 calendar days. A Party may request a new
inspection, for cause, identified to the other Party. If the exporting Party cannot
perform an inspection within a specified period of time, the importing Party may
perform an inspection on its own.
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                                        Article 14
                       Transmission ofproduct evaluation reports
Transmission of product evaluation reports will take place according to the importing
Party ' s specified procedures.
                                        Article 15
                           Monitoring continued equivalence
Monitoring activities will be carried out in accordance with Article 10 of the
Agreement.
                                        Article 16
                               Listing of Additional CABs
1. During the operational phase, additional CABs will be considered for equivalence
   using the procedures and criteria described in Articles 6, 7, and 9 of this Annex,
   taking into account the level of confidence gained in the overall regulatory system
   of the other Party.
2. Once a designating authority considers that such CABs, having undergone the
   procedures of Articles 6, 7, and 9 of this Annex, may be determined to be
   equivalent, it will then designate those bodies on an annual basis. Such procedures
   satisfy the procedures of Article 7(a) and (b) of the Agreement.
3. Following such annual designations, the procedures for confirmation of CABs
   under Articles 7(c) and (d) of the Agreement shall apply.
                                       CHAPTER 5
                         JOINT SECTORAL COMMITTEE
                                        Article 17
                 Role and composition of the Joint Sectoral Committee
1. A Joint Sectoral Management Committee is set up to monitor the activities under
   both the transitional and operational phases of this Annex.
2. The Committee will be co-chaired by a representative of the FDA for the U.S. and
   a representative of the EC who will each have one vote. Decisions will be taken by
   unanimous consent.
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 3. The JSC's functions will include:
        a. making a joint assessment of the equivalence of CABs;
        b. developing and maintaining the list of equivalent CABs, including any
            limitation in terms of their scope of activities and communicating the list to
            all authorities arid the Joint Committee;
        c. providing a forum to discuss issues relating to this Annex, including
            concerns that a CAB may no longer be equivalent and opportunity to
            review product coverage; and
        d. consideration of the issue of suspension.
                                          CHAPTER 6
              HARMONIZATION AND INFORMATION EXCHANGE
                                           Article 18
                                        Harmonization
During both the transitional and operational phases of this Agreement, both Parties
intend to continue to participate in the activities of the Global Harmonization Task
Force and utilize the results of those activities to the extent possible. Such
participation involves developing and reviewing documents developed by the Global
Harmonization Task Force and jointly determining whether they are applicable to the
implementation of this Agreement.
                                          Article 19
                                   Regulatory cooperation
The Parties and authorities shall inform and consult with one another, as permitted by
law, of proposals to introduce new controls or to change existing technical regulations
or inspection procedures and to provide the opportunity to comment on such
proposals.
The Parties shall notify each other in writing of any changes to Appendix 1.
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                                        Article 20
              Alert system and exchange ofpost-market vigilance reports
1. An alert system will be set up during the transition period and maintained
   thereafter by which the Parties will notify each other when there is an immediate
   danger to public health. Elements of such a system will be described in an
   Appendix to be attached to this Sectoral Annex. As part of that system, each Party
   shall notify the other Party of any confirmed problem reports, corrective actions, or
   recalls. These reports are regarded as part of ongoing investigations.
2. Contact points will be agreed between both Parties to permit authorities to be made
   aware with the appropriate speed in case of quality defect, batch recalls,
   counterfeiting and other problems concerning quality, which could necessitate
   additional controls or suspension of the distribution of the product.
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                                       APPENDIX 1
     RELEVANT LEGISLATION, REGULATIONS AND PROCEDURES
1. For the European Union the following legislation applies to Article 2 paragraph 1 :
        a. Council Directive 90/385/EEC of 20 June 1990 on active implantable
           medical devices - OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment
           procedures.
           * Annex 2 (with the exception of section 4)
           *Annex 4
           *Annex 5
        b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ No.
           L 169,12.7.1993, p.l. Conformity assessment procedures.
           * Annex 2 (with the exception of section 4)
           *Annex 3
           *Annex 4
           *Annex 5
           *Annex 6
2. For the United States, the following legislation applies to Article 2 paragraph 1 :
        a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 321 et seq.
       b. The Public Health Service Act, 42 U.S.C. §§ 201 et seq.
       c. Regulations of the United States Food and Drug Administration found at 21
           C.F.R., in particular, Parts 800 to 1299.
       d. Medical Devices; Third-Party Review of Selected Premarket Notifications;
           Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3, 1996).
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                                              APPENDIX 2
                              SCOPE OF PRODUCT COVERAGE
 1. Initial Coverage of the Transition Period
     Upon entry into force of this Annex,1 products qualifying for the transitional
     arrangements under this Agreement include:
          a. All Class I products requiring premarket evaluations in the United States -
              see Table 1.
          b. Those Class II products listed in Table 2.
2. During the Transition Period:
     The Parties will jointly identify additional product groups, including their related
     accessories, in line with their respective priorities as follows:
          a. Those for which review may be based primarily on written guidance which
              the Parties will use their best efforts to prepare expeditiously; and
          b. Those for which review may be based primarily on international standards,
              in order for the Parties to gain the requisite experience.
     The corresponding additional product lists will be phased in on an annual basis.
     The Parties may consult with industry and other interested Parties in determining
     which products will be added.
3. Commencement of the Operational Period:
          a. At the commencement of the operational period, product coverage shall
              extend to all Class I/II products covered during the transition period.
          b. FDA will expand the program to categories of Class II devices as is
              consistent with the results of the pilot, and with the FDA's ability to write
              guidance documents if the device pilot for the third party review of medical
              devices is successful. The MRA will cover to the maximum extent feasible
              all Class II devices listed in Table 3 for which FDA-accredited third-party
              review is available in the U.S..
4.         Unless explicitly included by joint decision of the Parties, this agreement does
      not cover any U.S. Class II -tier 3 or any Class III product under either system.
1
  It is understood that the date of entry into force will not occur prior to June 1, 1998, unless the Parties
decide otherwise.
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                                 TABLE 1
     CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS
      IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT
         COVERAGE AT BEGINNING OF TRANSITION PERIOD
TABLE 1: CLASS I PRODUCTS REQUIRING PREMARKET
EVALUATIONS IN THE UNITED STATES
ANESTHESIOLOGY PANEL (868)
   Section               Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
***************
  868.1910              ESOPHAGEAL STETHOSCOPE .
                         BZW - STETHOSCOPE, ESOPHAGEAL
  868.5620               BREATHING MOUTHPIECE
                         BYP - MOUTHPIECE, BREATHING
  868.5640              MEDICINAL NONVENTILATORY NEBULIZER
                        (ATOMIZER)
                        CCQ - NEBULIZER, MEDICINAL, NON-
                        VENTILATORY (ATOMIZER)
  868.5675               REBREATHING DEVICE
                         BYW - DEVICE, REBREATHING
  868.5700              NONPOWERED OXYGEN TENT
                         FOG - HOOD, OXYGEN, INFANT
                         BYL - TENT, OXYGEN
  868.6810              TRACHEOBRONCHIAL SUCTION CATHETER
                        BSY - CATHETERS, SUCTION,
                        TRACHEOBRONCHIAL
                                  83
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CARDIOVASCULAR PANEL
    Section                        Regulation Name
      No.                          Product Code - Device Name
************
a*******************************************************************
***************
   (NONE)
DENTAL PANEL (872)
    Section                        Regulation Name
      No.                          Product Code - Device Name
************
*********************************************************************
***************
   872.3400                       KARAYA AND SODIUM BORATE WITH OR
                                  WITHOUT ACACIA DENTURE ADHESIVE
                                  KOM - ADHESIVE, DENTURE, ACACIA AND
                                  KARAYA WITH SODIUM BORATE
   872.3700                       DENTAL MERCURY (U.S.P)
                                  ELY - MERCURY
   872.4200                       DENTAL HANDPIECES AND ACCESSORIES
                                  EBW - CONTROLLER, FOOD, HANDPIECE AND
                                  CORD
                                  EFB - HANDPIECE, AIR-POWERED, DENTAL
                                  EFA - HANDPIECE, BELT AND/OR GEAR DRIVEN,
                                  DENTAL
                                  EGS - HANDPIECE, CONTRA- AND RIGHT-ANGLE
                                  ATTACHMENT, DENTAL
                                  EKX - HANDPIECE, DIRECT DRIVE,
                                  AC-POWERED
                                  EKY - HANDPIECE, WATER-POWERED
   872.6640                        DENTAL OPERATIVE UNIT
                                   EIA - UNIT, OPERATIVE DENTAL
                                               84
                                                    97               Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
EAR, NOSE, AND THROAT PANEL (874)
   Section               Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
***************
  874.1070              SHORT INCREMENT SENSITIVITY INDEX (SISI)
                        ADAPTER
                        ETR - ADAPTER, SHORT INCREMENT
                        SENSITIVITY INDEX (SISI)
  874.1500              GUSTOMETER
                        ETM - GUSTOMETER
  874.1800              AIR OR WATER CALORIC STIMULATOR
                        KHH - STIMULATOR, CALORIC-AIR
                        ETP - STIMULATOR, CALORIC-WATER
  874.1925              TOYNBEE DIAGNOSTIC TUBE
                        ETK - TUBE, TOYNBEE DIAGNOSTIC
  874.3300              HEARING AID
                        LRB - FACE PLATE HEARING-AID
                        ESD - HEARING-AID, AIR-CONDUCTION
  874.4100              EPISTAXIS BALLOON
                        EMX - BALLOON, EPISTAXIS
  874.5300              ENT EXAMINATION AND TREATMENT UNIT
                        ETF - UNIT, EXAMINING/TREATMENT, ENT
  874.5550              POWERED NASAL IRRIGATOR
                        KMA - IRRIGATOR, POWERED NASAL
  874.5840              ANTISTAMMERING DEVICE
                        KTH - DEVICE, ANTI-STAMMERING
                                   85
                                 98                 Initialled on 20 Jtfne 1997
 ---pagebreak--- US-EC MRA Medical Devices Annex
GASTROENTEROLOGY - UROLOGY PANEL (876)
    Section              Regulation Name
      No.                Product Code - Device Name
************
*********************************************************************
***************
   876.5160            ^ UROLOGICAL CLAMPS FOR MALES
                         FHA - CLAMP, PENILE
   876.5210              ENEMA KIT
                         FCE - KIT, ENEMA, (FOR CLEANING PURPOSE)
  876.5250               URINE COLLECTOR AND ACCESSORIES
                         FAQ - BAG, URINE COLLECTION, LEG, FOR
EXTERNAL USE
GENERAL HOSPITAL PANEL (880)
    Section              Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
***************
  880.5270               NEONATAL EYE PAD
                         FOK - PAD, NEONATAL EYE
  880.5420               PRESSURE INFUSOR FOR I.V. BAG
                         KZD - INFUSOR, PRESSURE, FOR I.V. BAGS
  880.5680               PEDIATRIC POSITION HOLDER
                         FRP - HOLDER, INFANT POSITION
  880.6250              PATIENT EXAMINATION GLOVE
                        LZB - FINGER COT
                        FMC - GLOVE, PATIENT EXAMINATION
                        LYY - GLOVE, PATIENT EXAMINATION, LATEX
                        LZA - GLOVE, PATIENT EXAMINATION, POLY
                        LZC - GLOVE, PATIENT EXAMINATION,
                        SPECIALITY
                        LYZ - GLOVE, PATIENT EXAMINATION, VINYL
  880.6375               PATIENT LUBRICANT
                         KMJ - LUBRICANT, PATIENT
                                   86
                                  Q Q               Initialled on 20 June 1997
 ---pagebreak---  US-EC MRA Medical Devices Annex
   880.6760              PROTECTIVE RESTRAINT
                         BRT - RESTRAINT, PATIENT, CONDUCTIVE
                         FMQ - RESTRAINT, PROTECTIVE
NEUROLOGY PANEL (882)
    Section              Regulation Name
      No.                Product Code - Device Name
************
*********************************************************************
***************
   882.1030              ATAXIAGRAPH
                         GWW - ATAXIAGRAPH
   882.1420             ELECTROENCEPHALOGRAM (EEG) SIGNAL
                        SPECTRUM ANALYZER
                        GWS - ANALYZER, SPECTRUM,
                        ELECTROENCEPHALOGRAM SIGNAL
  882.4060               VENTRICULAR CANNULA
                         HCD - CANNULA, VENTRICULAR
  882.4545              SHUNT SYSTEM IMPLANTATION INSTRUMENT
                        GYK - INSTRUMENT, SHUNT SYSTEM
                        IMPLANTATION
  882.4650 -            NEUROSURGICAL SUTURE NEEDLE
                         HAS - NEEDLE, NEUROSURGICAL SUTURE
  882.4750               SKULL PUNCH
                         GXJ - PUNCH, SKULL
OBSTETRICS AND GYNECOLOGY PANEL
    Section              Regulation Name
     No.                Product Code - Device Name
************
*********************************************************************
***************
   (NONE)
                                   87
                               100                  Initialled on 20 June 1997
 ---pagebreak--- US-EC MRA Medical Devices Annex
OPHTHALMOLOGY PANEL (886)
   Section               Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
***************
  886.1780               RETINOSCOPE
                         HKM - RETINOSCOPE, BATTERY-POWERED
  886.1940               TONOMETER STERILIZER
                         HKZ - STERILIZER, TONOMETER
  886.4070              POWERED CORNEAL BURR
                        HQS - BURR, CORNEAL, AC-POWERED
                        HOG - BURR, CORNEAL, BATTERY-POWERED
                        HRG - ENGINE, TREPHINE, ACCESSORIES,
                        AC-POWERED
                        HFR - ENGINE, TREPHINE, ACCESSORIES,
                        BATTERY-POWERED
                        HLD - ENGINE, TREPHINE, ACCESSORIES,
                        GAS-POWERED
  886.4300               KERATOME
                         HNO - KERATONE, AC-POWERED
                         HMY - KERATONE, BATTERY-POWERED
  886.5850              SUNGLASSES (NON-PRESCRIPTION)
                        HQY - SUNGLASSES (NON-PRESCRIPTION
                        INCLUDING PHOTOSENSITIVE)
ORTHOPEDIC PANEL (888)
   Section               Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
***************
  888.1500               AC-POWERED GONIOMETER
                         KQX - GONIOMETER, AC-POWERED
  888.4150               CALIPERS FOR CLINICAL USE
                         KTZ - CALIPER
                                    88
                                  j[ Q i            Initialled on 20 June 1997
 ---pagebreak--- US-EC MRA Medical Devices Annex
PHYSICAL MEDICINE PANEL (890)
   Section               Regulation Name
     No.      -          Product Code - Device Name
************
*********************************************************************
***************
  890.3850               MECHANICAL WHEELCHAIR
                         LBE - STROLLER, ADAPTIVE
                         IOR - WHEELCHAIR, MECHANICAL
  890.5180               MANUAL PATIENT ROTATION BED
                         INY - BED, PATIENT ROTATION, MANUAL
  890.5710               HOT OR COLD DISPOSABLE PACK
                         IMD - PACK, HOT OR COLD, DISPOSABLE
RADIOLOGY PANEL (892)
   Section               Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
***************
  892.1100               SCINTILLATION GAMMA CAMERA
                         IYX - CAMERA, SCINTILLATION (GAMMA)
  892.1110               POSITRON CAMERA
                         IZC - CAMERA, POSITRON
  892.1300              NUCLEAR RECTILINEAR SCANNER
                         IYW - SCANNER, RECTILINEAR, NUCLEAR
  892.1320              NUCLEAR UPTAKE PROBE
                         IZD - PROBE, UPTAKE, NUCLEAR
  892.1330              NUCLEAR WHOLE BODY SCANNER
                        JAM - SCANNER, WHOLE BODY, NUCLEAR
  892.1410              NUCLEAR ELECTROCARDIOGRAPH
                        SYNCHRONIZER
                        IVY - SYNCHRONIZER, ELECTROCARDIOGRAPH,
                        NUCLEAR
                                    89
                              1 09                  Initialled on 20 June 1997
                              X. \J ,lJ
 ---pagebreak--- US - EC MRA Medical Devices Annex
  892.1890              RADIOGRAPHIC-FILM ILLUMINATOR
                        IXC - ILLUMINATOR, RADIOGRAPHIC-FILM
                        JAG - ILLUMINATOR, RADIOGRAPHIC-FILM,
                        EXPLOSION-PROOF
  892.1910              RADIOGRAPHIC GRID
                        IXJ -GRID, RADIOGRAPHIC
  892.1960              RADIOGRAPHIC INTENSIFYING SCREEN
                        WAM - SCREEN, INTENSIFYING, RADIOGRAPHIC
  892.1970              RADIOGRAPHIC ECG/RESPIRATQR
                        SYNCHRONIZER
                        IXO - SYNCHRONIZER, ECG/RESPIRATOR,
                        RADIOGRAPHIC
  892.5650              MANUAL RADIONUCLIDE APPLICATOR SYSTEM
                        IWG - SYSTEM, APPLICATOR, RADIONUCLIDE,
                        MANUAL
GENERAL AND PLASTIC SURGERY PANEL (878)
   Section               Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
***************
  878.4200              INTRODUCTION/DRAINAGE CATHETER AND
                        ACCESSORIES
                        KGZ - ACCESSORIES, CATHETER
                        GCE - ADAPTOR, CATHETER
                        FGY - CANNULA, INJECTION
                        GBA - CATHETER, BALLOON TYPE
                        GBZ - CATHETER, CHOLANGIOGRAPHY
                        GBQ - CATHETER, CONTINUOUS IRRIGATION
                        GBY - CATHETER, EUSTACHIAN, GENERAL &
                        PLASTIC SURGERY
                        JCY - CATHETER, INFUSION
                        GBX - CATHETER, IRRIGATION
                        GBP - CATHETER, MULTIPLE LUMEN
                        GBO - CATHETER, NEPHROSTOMY, GENERAL &
                        PLASTIC SURGERY
                        GBN - CATHETER, PEDIATRIC, GENERAL &
                        PLASTIC SURGERY
                                   90
                                  J- V O            Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
                        GBW - CATHETER, PERITONEAL
                        GBS - CATHETER, VENTRICULAR, GENERAL &
                        PLASTIC SURGERY
                        GCD - CONNECTOR, CATHETER
                        GCC - DILATOR, CATHETER
                        GCB - NEEDLE, CATHETER
  878.4320              REMOVABLE SKIN CLIP
                        FZQ - CLIP, REMOVABLE (SKIN)
  878.4460              SURGEON'S GLOVES
                        KGO - SURGEON'S GLOVES
  878.4680              NONPOWERED, SINGLE PATIENT, PORTABLE
                        SUCTION APPARATUS
                        GCY - APPARATUS, SUCTION, SINGLE PATIENT
                        USE, PORTABLE, NONPOWERED
  878.4760              REMOVABLE SKIN STAPLE
                        GDT - STAPLE, REMOVABLE (SKIN)
GENERAL AND PLASTIC SURGERY PANEL (878) (CONTINUED)
   Section               Regulation Name
     No.                 Product Code - Device Name
************
*********************************************************************
****************
  878.4820              AC-POWERED, BATTERY-POWERED, AND
                        PNEUMATICALLY POWERED SURGICAL
                        INSTRUMENT MOTOR
                        GFG - BIT, SURGICAL
                        GFA - BLADE, SAW, GENERAL & PLASTIC
                        SURGERY
                        DWH - BLADE, SAW, SURGICAL,
                        CARDIOVASCULAR
                        BRZ - BOARD, ARM (WITH COVER)
                        GFE - BRUSH, DERMABRASION
                        GFF - BUR, SURGICAL, GENERAL & PLASTIC
                        SURGERY
                        KDG - CHISEL (OSTEOTOME)
                        GFD - DERMATOME
                        GFC - DRIVER, SURGICAL, PIN
                        GFB - HEAD, SURGICAL, HAMMER
                                   91
                                 104                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
                       GEY - MOTOR, SURGICAL INSTRUMENT,
                       AC-POWERED
                       GET - MOTOR, SURGICAL INSTRUMENT,
                       PNEUMATIC POWERED
                       DWI - SAW, ELECTRICALLY POWERED
                       KFK - SAW, PNEUMATICALLY POWERED
                       HAB - SAW, POWERED, AND ACCESSORIES
  878.4960            AIR OR AC-POWERED OPERATING TABLE AND
                      AIR OR AC-POWERED OPERATING CHAIR &
                      ACCESSORIES
                      GBB - CHAIR, SURGICAL, AC-POWERED
                      FQO - TABLE, OPERATING-ROOM, AC-POWERED
                      GDC - TABLE, OPERATING-ROOM, ELECTRICAL
                      FWW - TABLE, OPERATING-ROOM, PNEUMATIC
                      JEA - TABLE, SURGICAL WITH ORTHOPEDIC
                      ACCESSORIES, AC-POWERED
 880.5090             LIQUID BANDAGE
                       KMF - BANDAGE, LIQUID
                                92
                             105
                                              Initialled on 20 June 1997
 ---pagebreak---  US - EC MRA Medical Devices Annex
                                                  TABLE 2
                           CLASS II MEDICAL DEVICES INCLUDED
                              IN SCOPE OF PRODUCT COVERAGE
                           AT BEGINNING OF TRANSITION PERIOD
  • U.S. to develop guidance documents identifying U.S. requirements and EC to
                        identify standards needed to meet EC requirements
 RA           892.1000          MAGNETIC RESONANCE DIAGNOSTIC DEVICE
                                MOS - COIL, MAGNETIC RESONANCE. SPECIALTY
                                LNH - SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
                                LNI - SYSTEM, NUCLEAR MAGNETIC RESONANCE SPECTROSCOPIC
 Diagnostic Ultrasound:
RA           892.1540          NONFETAL ULTRASONIC MONITOR
                               JAF - MONITOR. ULTRASONIC, NONFETAL
RA           892.1550          ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
                               IYN - SYSTEM, IMAGING, PULSED DOPPLER. ULTRASONIC
RA           892.1560          ULTRASONIC PULSED ECHO IMAGING SYSTEM
                               IYO - SYSTEM. IMAGING, PULSED ECHO, ULTRASONIC
RA           892.1570          DIAGNOSTIC ULTRASONIC TRANSDUCER
                               ITX - TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Diagnostic X-Ray Imaging Devices (except mammographie x-ray systems):
RA           892.1600          ANGIOGRAPHIC X-RAY SYSTEM
                               IZI - SYSTEM. X-RAY, ANGIOGRAPHIC
RA           892.1650          IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
                               MQB - SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
                               JAA - SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
RA           892.1680          STATIONARY X-RAY SYSTEM
                               KPR - SYSTEM. X-RAY. STATIONARY
RA           892.1720          MOBILE X-RAY SYSTEM
                               IZL - SYSTEM, X-RAY, MOBILE
RA           892.1740          TOMOGRAPHIC X-RAY SYSTEM
                               IZF - SYSTEM, X-RAY, TOMOGRAPHIC
RA           892.1750          COMPUTED TOMOGRAPHY X-RAY SYSTEM
                               JAK - SYSTEM. X-RAY, TOMOGRAPHY. COMPUTED
ECG-Related Devices:
CV           870.2340          ELECTROCARDIOGRAPH
                               DPS - ELECTROCARDIOGRAPH
                               MLC - MONITOR. ST SEGMENT
CV           870.2350          ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR
                               DRW - ADAPTOR, LEAD SWITCHING. ELECTROCARDIOGRAPH
CV           870.2360          ELECTROCARDIOGRAPH ELECTRODE
                               DRX - ELECTRODE, ELECTROCARDIOGRAPH
CV           870.2370          ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER
                               KRC - TESTER. ELECTRODE. SURFACE, ELECTROCARDIOGRAPHIC
NE           8821400           ELECTROENCEPHALOGRAPH
                                                     93
                                              1  Q £>                     Initialled on 2 0 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
                              GWQ - ELECTROENCEPHALOGRAPH
HO            880.5725        INFUSION PUMP (external only)
                              MRZ - ACCESSORIES. PUMP, INFUSION
                              FRN - PUMP, INFUSION
                              LZF - PUMP. INFUSION. ANALYTICAL SAMPLING
                              MEB - PUMP, INFUSION, ELASTOMERIC
                              LZH - PUMP, INFUSION, ENTERAL
                              MHD - PUMP. INFUSION, GALLSTONE DISSOLUTION
                              LZG - PUMP, INFUSION, INSULIN
                              MEA - PUMP, INFUSION, PCA
Ophthalmic Instruments:
OP            886.1570        OPHTHALMOSCOPE
                              HLI - OPHTHALMOSCOPE, AC-POWERED
                              HLJ - OPHTHALMOSCOPE, BATTERY-POWERED
OP            886.1780        RETINOSCOPE
                              HKL - RETINOSCOPE, AC-POWERED
OP           886.1850         AC-POWERED SLIT-LAMP BIOMICROSCOPE
                              HJO - BIOMICROSCOPE. SLIT-LAMP, AC-POWERED
OP           886.4150         VITREOUS ASPIRATION AND CUTTING INSTRUMENT
                              MMC - DILATOR. EXPANSIVE IRIS (ACCESSORY)
                              HQE - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING. AC-POWERED
                              HKP - INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, BATTERY-POWERED
                              MLZ - VITRECTOMY, INSTRUMENT CUTTER
OP           886.4670         PHACOFRAGMENTATION SYSTEM
                              HOC - UNIT, PHACOFRAGMENTATION
SU           878.4580         SURGICAL LAMP
                              HBI - ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
                              FTF - ILLUMINATOR. NON-REMOTE
                              FTG - ILLUMINATOR, REMOTE
                              HJE - LAMP, FLUORESCEIN. AC-POWERED
                              FQP - LAMP, OPERATING-ROOM
                              FTD - LAMP, SURGICAL
                              GBC - LAMP, SURGICAL, INCANDESCENT
                              FTA - LIGHT, SURGICAL, ACCESSORIES
                              FSZ - LIGHT, SURGICAL, CARRIER
                              FSY - LIGHT, SURGICAL, CEILING MOUNTED
                              FSX - LIGHT. SURGICAL, CONNECTOR
                              FSW - LIGHT, SURGICAL, ENDOSCOPIC
                              FST - LIGHT. SURGICAL. FIBEROPTIC
                              FSS - LIGHT. SURGICAL, FLOOR STANDING
                              FSO - LIGHT. SURGICAL. INSTRUMENT
NE           882.5890         TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF
                              GZJ - STIMULATOR. NERVE. TRANSCUTANEOUS. FOR PAIN RELIEF
Noninvasive Blood Pressure Measurement Devices:
CV           870.1120         BLOOD PRESSURE CUFF
                              DXQ - CUFF. BLOOD-PRESSURE
CV           870.1130         NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM (except non-
oscillometric)
                              DXN - SYSTEM. MEASUREMENT. BLOOD-PRESSURE. NON-INVASIVE
                                                   94
                                                 107                      Initialled on 20 June 1997
 ---pagebreak---  US - EC MRA Medical Devices Annex
 HO           880.6880            STEAM STERILIZER (greater than 2 cubic feet)
                                   FLE - STERILIZER. STEAM
 Clinical Thermometers:
 HO           880.2910            CLINICAL ELECTRONIC THERMOMETER (except tympanic or pacifier)
                                  FLL - THERMOMETER, ELECTRONIC, CLINICAL
 AN           868.5630            NEBULIZER
                                  CAF - NEBULIZER (DIRECT PATIENT INTERFACE)
 AN           868.5925            POWERED EMERGENCY VENTILATOR
 Hypodermic Needles and Syringes (except anti-stick and self-destruct):
 HO           880.5570            HYPODERMIC SINGLE LUMEN NEEDLE
                                  MMK. - CONTAINER, SHARPES
                                  FMI - NEEDLE, HYPODERMIC. SINGLE LUMEN
                                  MHC - PORT, INTRAOSSEOUS. IMPLANTED
HO            880.5860            PISTON SYRINGE
                                  FMF - SYRINGE, PISTON
OR            888.3020            INTRAMEDULLARY FIXATION ROD
                                  HSB - ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
External Fixators (except devices with no external components):
OR            888.3030           SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES &
ACCESSORIES
                                 KTT - APPLIANCE, FIXATION. NAIL/BLADE/PLATE COMBINATION, MULTIPLE
COMPONENT
OR            888.3040           SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER
                                 HTY - PIN. FIXATION. SMOOTH
                                 JDW - PIN, FIXATION, THREADED
Selected Dental Materials:
DE           872.3060            GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE
                                 EJT - ALLOY, GOLD BASED, FOR CLINICAL USE
                                 EJS - ALLOY, PRECIOUS METAL. FOR CLINICAL USE
DE           872.3200            RESIN TOOTH BONDING AGENT
                                 KLE - AGENT, TOOTH BONDING, RESIN
DE           872.3275            DENTAL CEMENT
                                 EMA - CEMENT. DENTAL
                                 EMB - ZINC OXIDE EUGENOL
DE           872.3660            IMPRESSION MATERIAL
                                 ELW - MATERIAL, IMPRESSION
DE           872.3690            TOOTH SHADE RESIN MATERIAL
                                 EBF - MATERIAL. TOOTH SHADE, RESIN
DE           872.3710            BASE METAL ALLOY
                                 EJH - METAL. BASE
Latex Condoms:
OB           884.5300            CONDOM
                                 HIS - CONDOM
                                                          95
                                                      108                      Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
                                    TABLE 3
              MEDICAL DEVICES FOR POSSIBLE INCLUSION
                    IN SCOPE OF PRODUCT COVERAGE
                      DURING OPERATIONAL PERIOD
Anesthesiology Panel
 Product      Section    Device Name                                   Tier
 Family       No
 Anesthesia   868.5160   Gas machine for anesthesia or analgesia       2
 Devices
              868.5270   Breathing system heater                       2
              868.5440   Portable oxygen generator                     2
              868.5450   Respiratory gas humidifier                    2
            - 868.5630   Nebulizer                                     2
               868.5710  Electrically powered oxygen tent              2
              868.5880   Anesthetic vaporizer                          2
 Gas          868.1040   Powered Algesimeter                           2
 Analyser
              868.1075   Argon gas analyzer                            2
              868.1400   Carbon dioxide gas analyzer                   2
              868.1430   Carbon monoxide gas analyzer                  2
              868.1500   Enflurane gas analyzer                        2
              868.1620   Halothane gas analyzer                        2
              868.1640   Helium gas analyzer                           2
              868.1670   Neon gas analyzer                             2
              868.1690   Nitrogen gas analyzer                         2
              868.1700   Nitrous oxide gas analyzer                    2
              868.1720   Oxygen gas analyzer,                          2
              868.1730   Oxygen uptake computer                        2
                                      96
                                  109                     Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
Peripheral   868.2775 Electrical peripheral nerve stimulator         2
Nerve
 Stimulators
 Respiratory 868.1750 Pressure plethysmograph                        2
 Monitoring
             868.1760 Volume plethysmograph                          2
             868.1780 Inspiratory airway pressure meter              2
             868.1800 Rhinoanemometer                                2
             868.1840 Diagnostic spirometer                          2
             868.1850 Monitoring spirometer                          2
             868.1860 Peak-flow meter for spirometry                 2
             868.1880 Pulmonary-function data calculator             2
             868.1890 Predictive pulmonary-function value            2
                      calculator
             868.1900 Diagnostic pulmonary-function                  2
                      interpretation calculator
             868.2025 Ultrasonic air embolism monitor               2
             868.2375 Breathing frequency monitor (except            2
                      apnea detectors)
             868.2480 Cutaneous carbon dioxide (PCCO2)               2
                      monitor
             868.2500 Cutaneous oxygen monitor (for an infant       2
                      not under gas anesthesia)
             868.2550 Pneumotachomometer                            2
             868.2600 Airway pressure monitor                       2
             868.5665 Powered percussor                             2
             868.5690 Incentive spirometer                          2
Ventilator   868.5905 Noncontinuous ventilator (IPPB)               2
             868.5925 Powered emergency ventilator                  2
             868.5935 External negative pressure ventilator         2
             868.5895 Continuous ventilator                         2
             868.5955 Intermittent mandatory ventilation            2
                      attachment
             868.6250 Portable air compressor                       2
                                   97
                                110                    Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
Cardiovascular Panel
 Product        Section  Device Name                                 Tier
 Family         No
 Cardiovascular 870.1425 Programmable diagnostic computer            2
 Diagnostic
                870.1450 Densitometer                                2
                870.2310 Apex cardiograph (vibrocardiograph)         2
                870.2320 B allistocardiograph                        2
                870.2340 Electrocardiograph                          2
                870.2350 Electrocardiograph lead switching            1
                         adaptor
                870.2360 Electrocardiograph electrode                2
                870.2370 Electrocardiograph surface electrode        2
                         tester
                870.2400 Vectorcardiograph                           1
                870.2450 Medical cathode-ray tube display            1
                870.2675 Oscillometer                                2
                870.2840 Apex cardiographic transducer               2
                870.2860 Heart sound transducer                      2
Cardiovascular           Valve, pressure relief,
Monitoring               cardiopulmonary bypass
                870.1100 Blood pressure alarm                        2
                870.1110 Blood pressure computer                     2
                870.1120 Blood pressure cuff                         2
                870.1130 Noninvasive blood pressure                  2
                         measurement system
                870.1140 Venous blood pressure manometer             2
                870.1220 Electrode recording catheter or             2
                         electrode recording probe
                870.1270 Intracavitary phonocatheter system          2
                870.1875 Stethoscope (electronic)                    2
                                   98
                                      111              Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
           870.2050   Biopotential amplifier and signal              2
                      conditioner
           870.2060   Transducer signal amplifier and                2
                      conditioner
           870.2100   Cardiovascular blood flow-meter                2
           870.2120   Extravascular blood flow probe                 2
           870.2300   Cardiac monitor (including                     2
                      cardiotachometer and rate alarm)
           870.2700   Oximeter                                       2
           870.2710   Ear oximeter                                   2
           870.2750   Impedance phlebograph                          2
           870.2770   Impedance plethysmograph                       2
       -   870.2780   Hydraulic, pneumatic, or photoelectric         2
                      plethysmography
           870.2850   Extravascular blood pressure transducer        2
           870,2870   Catheter tip pressure transducer               2
           870.2880   Ultrasonic transducer                          2
           870.2890   Vessel occlusion transducer                    2
           870.2900   Patient transducer and electrode cable         2
                      (including connector)
           870.2910   Radiofrequency physiological signal            2
                      transmitter and receiver
           870.2920   Telephone electrocardiograph                   2
                      transmitter and receiver
           870.4205   Cardiopulmonary bypass bubble detector         2
           870.4220   Cardiopulmonary bypass heart-lung              2
                      machine console
           870.4240   Cardiovascular bypass heat exchanger           2
           870.4250   Cardiopulmonary bypass temperature             2
                      controller
           870.4300   Cardiopulmonary bypass gas control unit 2
           870.4310   Cardiopulmonary bypass coronary                2
                      pressure gauge
           870.4330   Cardiopulmonary bypass on-line blood           2
                      gas monitor
           870.4340   Cardiopulmonary bypass level sensing           2
                      monitor and/or control
                                   99
                                         JL JL r-J      Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
                 870.4370  Roller-type cardiopulmonary bypass          2
                           blood pump
                 870.4380  Cardiopulmonary bypass pump speed           2
                           control
                 870.4410  Cardiopulmonary bypass in-line              2
                           blood 2as sensor
 Cardiovascular  870.5050  Patient care suction apparatus             2
 Therapeutic
                 870.5900  Thermal regulation system                  2
 Defibrillator   870.5300  DC-defribrillator (including paddles)      2
                 870.5325  Defibrillator tester                       2
 Echocardiograph 870.2330  Echocardiograph                            2
 Pacemaker &     870.1750 External programmable pacemaker             2
Accessories               pulse generator
                 870.3630 Pacemaker generator function                2
                          analyzer
                 870.3640 Indirect pacemaker generator function       2
                          analyzer
                 870.3720 Pacemaker electrode function tester         2
Miscellaneous    870.1800 Withdrawal-infusion pump                    2
                 870.2800 Medical magnetic tape recorder              2
                 None     Batteries, rechargeable, class II
                          devices
                                   100
                                      113               Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
Dental Panel
 Product     Section  Device Name                                     Tier
 Family      No
 Dental      872.1720 Pulp tester                                      2
 Equipment
             872.1740 Caries detection device                         2
             872.4120 Bone cutting instrument and accessories         2
             872.4465 Gas-powered jet injector                        2
             872.4475 Spring-powered jet injector                     2
             872.4600 Intraoral ligature and wire lock                2
             872.4840 Rotary scaler                                   2
             872.4850 Ultrasonic scaler                               2
             872.4920 Dental electrosurgical unit and                 2
                      accessories
             872.6070 Ultraviolet activator for polymerization        2
             872.6350 Ultraviolet detector                            2
 Dental      872.3050 Amalgam alloy                                   2
 Material
             872.3060 Gold-based alloys and precious metal            2
                      alloys for clinical use
             872.3200 Resin tooth bonding agent                       2
             872.3250 Calcium hydroxide cavity liner                  2
             872.3260 Cavity varnish                                  2
             872.3275 Dental cement (other than zinc oxide-           2
                      eugenol)
             872.3300 Hydrophilic resin coating for dentures          2
             872.3310 Coating material for resin fillings             2
             872.3590 Preformed plastic denture tooth                 2
             872.3660 Impression material                             2
             872,3690 Tooth shade resin material                      2
             872.3710 Base metal alloy                                2
                                   101
                                        114              Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
              872.3750 Bracket adhesive resin and tooth                2
                       conditioner
              872.3760 Denture relining, repairing, or rebasing        2
                       resin
              872.3765 Pit and fissure sealant and conditioner         2
              872.3770 Temporary crown and bridge resin                2
              872.3820 Root canal filling resin (other than            2
                       chloroform use)
              872.3920 Porcelain tooth                                 2
 Dental X-ray 872.1800 Extraoral source x-ray system                   2
              872.1810 Intraoral source x-ray system                   2
 Dental       872.4880 Intraosseous fixation screw or wires            2
 Implants
              872.3890 Endodontic stabilizing splint                   2
 Orthodontic  872.5470 Orthodontic plastic bracket                     2
Ear/Nose/Throat Panel
 Product      Section  Device Name                                    Tier
 Family       No
 Diagnostic   874.1050 Audiometer                                      2
 Equipment
              874.1090 Auditory impedance tester                       2
              874.1120 Electronic noise generator for                 2
                       audiometric testing
              874.1325 Electroglottograph                             2
              874.1820 Surgical nerve stimulator/locator              2
                                   102
                                      115                Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
 Hearing       874.3300    Hearing aid (for bone-conduction)              2
 Aids
               874.3310    Hearing aid calibrator and analysis            2
                           system
               874.3320    Group hearing aid or group auditory            2
                           trainer
               874.3330    Master hearing aid                             2
 Surgical       874.4250   Ear, nose, and throat electric or               1
 Equipment                 pneumatic surgical drill
               874.4490    Argon laser for otology, rhinology, and        2
                           laryngology
                874.4500   ENT microsurgical carbon dioxide laser         2
Gastroenterologv/Urologv Panel
 Product Family      Section     Device Name                               Tier
                     No
 Endoscope           876.1500    Endoscope and accessories                 2
 (including
 angioscopes,
 laparscopes,
 ophthalmic
 endoscopes)
                     876.4300    Endoscopic electrosurgical unit and       2
                                 accessories
 Gastroenterology    876.1725    Gastrointestinal motility monitoring       1
                                 system
 Hemodialysis        876.5600    Sorbent regenerated dialysate             2
                                 delivery system for hemodialysis
                     876.5630 Peritoneal dialysis system and               2
                                 accessories
                     876.5665 Water purification system for                2
                                 hemodialysis
                     876.5820 Hemodialysis system and                      2
                                 accessories
                     876.5830 Hemodialyzer with disposable insert          2
                                 (kiil-type)
                                         103
                                             116             Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
 Lithotriptor  876.4500  Mechanical lithotriptor                        2
 Urology       876.1620  Urodynamics measurement system                 2
 Equipment
               876.5320  Nonimplanted electrical continence             2
                         device
               876.5880  Isolated kidney perfusion and transport        2
                         system and accessories
General Hospital Panel
 Product Family Section    Device Name                                  Tier
                 No
 Infusion Pumps 880.2420 Electronic monitor for gravity flow            2
 and Systems               infusion systems
                 880.2460 Electrically powered spinal fluid             2
                           pressure monitor
                 880.5430 Nonelectrically powered fluid injector        2
                 880.5725 Infusion pump                                 2
Neonatal         880.5400 Neonatal incubator                            2
 Incubators
                 880.5410 Neonatal transport incubator                  2
                 880.5700 Neonatal phototherapy unit                    2
Piston Syringes 880.5570 Hypodermic single lumen needle                 1
                 880.5860 Piston syringe (except anti-stick)            1
                 880.6920 Syringe needle introducer                     2
Miscellaneous    880.2910 Clinical electronic thermometer               2
                 880.2920 Clinical mercury thermometer                  2
                 880.5100 AC-powered adjustable hospital bed            1
                                     104
                                         117              Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
               880.5500 AC-powered patient lift                        2
               880.6880 Steam Sterilizer (greater than 2 cubic         2
                        feet)
Neurology Panel
 Product Family         Section    Device Name                           Tier
                        No
 ?                      882.1020 Rigidity analyzer                       2
 7                      882.1610 Alpha monitor                           2
 Neuro-Diagnostic       882.1320   Cutaneous electrode                   2
                        882.1340   Nasopharyngeal electrode              2
                        882.1350   Needle electrode                      2
                        882.1400 Electroencephalograph                   2
                        882.1460  Nystagmograph                          2
                        882.1480   Neurological endoscope                2
                        882.1540   Galvanic skin response                2
                                   measurement device
                        882.1550 Nerve conduction velocity               2
                                   measurement device
                        882.1560 Skin potential measurement              2
                                  device
                        882.1570 Powered direct-contact                  2
                                  temperature measurement
                                  device
                        882.1620 Intracranial pressure                   2
                                   monitorins device
                        882.1835 Physiological signal amplifier          2
                        882.1845   Physiological signal                  2
                                  conditioner
                        882.1855 Electroencephalogram (EEG)              2
                                   telemetry system
                        882.5050 Biofeedback device                      2
 Echoencephalography    882.1240   Echoencephalograph                    2
                                    105
                                        118               Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
 RPG        882.4400  Radiofrequency lesion generator                2
 Neuro      none      Electrode, spinal epidural                    2
 Surgery
            882.4305 Powered compound cranial drills, burrs,        2
                     trephines, and their accessories
            882.4310 Powered simple cranial drills burrs,           2
                     trephines and accessories
            882.4360 Electric cranial drill motor                   2
            882.4370 Pneumatic cranial drill motor                  2
            882.4560 Stereotaxic instrument                         2
            882.4725 Radiofrequency lesion probe                    2
            882.4845 Powered rongeur                                2
            882.5500 Lesion temperature monitor                     2
Stimulators 882.1870 Evoked response electrical stimulator          2
            882.1880 Evoked response mechanical stimulator          2
            882.1890 Evoked response photic stimulator              2
            882.1900 Evoked response auditory stimulator            2
            882.1950 Tremor transducer                              2
            882.5890 Transcutaneous electrical nerve                2
                     stimulator for pain relief
                                 106
                                    119               Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
Obstetrics/Gvnecologv Panel
 Product Family Section    Device Name                                  Tier
                No
 Fetal          884.1660   Transcervical endoscope (amnioscope)         2
 Monitoring                and accessories
                884.1690   Hysteroscope and accessories (for            2
                           performance standards)
                884.2225 Obstetric-gynecologic ultrasonic               2
                           imager
                884.2600 Fetal cardiac monitor                          2
                884.2640 Fetal phonocardiographic monitor and           2
                           accessories
                884.2660 Fetal ultrasonic monitor and                   2
                           accessories
                884.2675 Fetal scalp circular (spiral) electrode        1
                           and applicator
                884.2700 Intrauterine pressure monitor and              2
                           accessories
                884.2720 External uterine contraction monitor           2
                           and accessories
                884.2740 Perinatal monitoring system and                2
                           accessories
                884.2960 Obstetric ultrasonic transducer and            2
                           accessories
 Gynecological  884.1720 Gynecologic laparoscope and                    2
 Surgery Equip.            accessories
                884.4160 Unipolar endoscopic coagulator-cutter          2
                           and accessories
                884.4550 Gynecologic surgical laser                     2
                884.4120 Gynecologic electrocautery and                 2
                           accessories
                884.5300 Condom                                         2
                                     107
                                    JL /*, \j
                                                          Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
 Product     Section   Device Name                                   Tier
 Family      No
 Ophthalm.   886.3320  Eye sphere implant                            2
 Implants
 Contact     886.1385  Polymethylmethacrylate (PMMA)                 2
 Lens                  diagnostic contact lens
             886.5916  Rigid gas permeable contact lens (daily       2
                       wear only)
 Diagnostic  886.1120  Opthalmic camera
 Equipment
             886.1220  Corneal electrode
             886.1250  Euthyscope (AC-powered)
             886.1360  Visual field laser instrument
             886.1510  Eye movement monitor
             886.1570  Ophthalmoscope
             886.1630  AC-powered photostimulator
             886.1640  Ophthalmic preamplifier
             886.1670  Ophthalmic isotope uptake probe              2
             886.1780  Retinoscope (AC-powered device)
             886.1850 ,AC-powered slitlamp biomicroscope
             886.1930  Tonometer and accessories                    2
             886.1945  Transilluminator (AC-powered device)          1
             886.3130  Ophthalmic conformer                         2
(Diagnostic/ 886.4670  Phacofragmentation System                    2
Surgery
Equipment)
Ophthalm.    886.3340  Extraocular orbital implant                  2
Implants
             886.3800  Scleral shell                                2
                                   108
                                      121              Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
 Surgical     880.5725 Infusion pump (performance standards)         2
 Equipment
              886.3100 Ophthalmic tantalum clip                      2
              886.3300 Absorbable implant (scleral buckling          2
                       method)
              886.4100 Radiofrequency electrosurgical cautery        2
                       apparatus
              886.4115 Thermal cautery unit                          2
              886.4150 Vitreous aspiration and cutting               2
                       instrument
              886.4170 Cryophthalmic unit                            2
              886.4250 Ophthalmic electrolysis unit (AC-             1
                       powered device)
              886.4335 Operating headlamp (AC-powered                1
                       device)
              886.4390 Ophthalmic laser                             2
              886.4392 Nd:YAG laser for posterior capsulotomy 2
              886.4400 Electronic metal locator                      1
              886.4440 AC-powered magnet                             1
             886.4610  Ocular pressure applicator                   2
             886.4690  Ophthalmic photocoagulator                   2
             886.4790  Ophthalmic sponge                            2
             886.5100  Ophthalmic beta radiation source             2
             none      Ophthalmoscopes, replacement batteries, 1
                       hand-held
Orthopedic Panel
Product      Section   Device Name                                  Tier
Family       No
                                  109
                                     1 oo              Initialled on 20 June 1997
                                     JL fi*> ,'j
 ---pagebreak--- US - EC MRA Medical Devices Annex
 Implants     888.3010  Bone fixation cerclage                           2
              888.3020  Intramedullary fixation rod                      2
              888.3030  Single/multiple component metallic               2
                        bone fixation appliances and accessories
              888.3040  Smooth or threaded metallic bone                 2
                        fixation fastener
              888.3050  Spinal interlaminal fixation orthosis            2
              888.3060  Spinal intervertebral body fixation              2
                        orthosis
 Surgical     888.1240  AC-powered dynamometer                           2
 Equipment
              888.4580  Sonic surgical instrument and                    2
                        accessories/attachments
              none      Accessories, fixation, spinal interlaminal 2
              none      Accessories, fixation, spinal                    2
                        intervertebral body
              none      Monitor, pressure, intracompartmental            1
              none,     Orthosis, fixation, spinal intervertebral       2
                        fusion
              none      Orthosis, spinal pedicle fixation
              none      System, cement removal extraction                1
Physical Medicine Panel
 Product      Section   Device Name                                     Tier
 Family       No
 Diagnostic   890.1225  Chronaximeter                                   2
 Equipment
              890.1375  Diagnostic electromyograph                      2
              890.1385  Diagnostic electromyograph needle               2
                        electrode
              890.1450  Powered reflex hammer                           2
              890.1850  Diagnostic muscle stimulator                    2
 or (Therapy) 890.5850  Powered muscle stimulator                       2
                                    110
                                   123                     Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
 Therapeutic   890.5100   Immersion hydrobath                          2
 Equipment
               890.5110   Paraffin bath                                2
               890.5500   Infrared lamp                                2
               890.5720   Water circulating hot or cold pack           2
                890.5740  Powered heating pad                          2
Radiology Panel
 Product       Section No Device Name                                  Tier
 Family
 MRI            892.1000  Magnetic resonance diagnostic device         2
 Ultrasound     884.2660   Fetal ultrasonic monitor and                2
 Diagnostic                accessories
               892.1540    Nonfetal ultrasonic monitor
                892.1560   Ultrasonic pulsed echo imaging              2
                           system
                892.1570   Diagnostic ultrasonic transducer            2
                892.1550   Ultrasonic pulsed doppler imaging
                           system
 Angiographic    892.1600 Angiographic x-ray system                    2
                                    111
                                     124                 Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
  Diagnostic 892.1610 Diagnostic x-ray beam-limiting device          2
  X-Ray
             892.1620 Cine or spot fluorographic x-ray Camera        2
             892.1630 Electrostatic x-ray imaging system             2
             892.1650 Image-intensified fluoroscopic x-ray           2
                      system
             892.1670 Spot film device                               2
             892.1680 Stationary x-ray system                        2
             892.1710 Mammographic x-ray system                      2
             892.1720 Mobile x-ray system                            2
             892.1740 Tomographic x-ray system                       1
             892.1820 Pneumoencephalographic chair                   2
             892.1850 Radiographic film cassette                     1
             892.1860 Radiographic film/cassestte changer            1
             892.1870 Radiographic film/cassette changer             2
                      programmer
             892.1900 Automatic radiographic film processor          2
             892.1980 Radiologic table                               1
 CT Scanner  892.1750 Computed tomography x-ray system
 Radiation   892.5050 Medical charged-particle radiation             2
 Therapy              therapy system
             892.5300 Medical neutron radiation therapy              2
                      system
             892.5700 Remote controlled radionuclide-                2
*
                      applicator system
             892.5710 Radiation therapy beam-shaping block           2
             892.5730 Radionuclide brachytherapy source              2
             892.5750 Radionuclide radiation therapy system          2
             892.5770 Powered radiation therapy patient              2
                      support assembly
             892.5840 Radiation therapy simulation system           2
             892.5930 Therapeutic x-ray tube housing assembly 1
                                  112
                                     125               Initialled on 20 June 1997
 ---pagebreak--- US - EC MRA Medical Devices Annex
 Nuclear         892.1170 Bone densitometer                             2
 Medicine
                 892.1200 Emission computed tomography                  2
                           system
                 892.1310 Nuclear tomography system                      1
                 892.1390 Radionuclide rebreathing system               2
General/Plastic Surgery Panel
 Product Family Section    Device Name                                  Tier
                 No
 Surgical Lamps 878.4630 Ultraviolet lamp for dermatologic              2
                           disorders
                 890.5500 Infrared lamp                                 2
                 878.4580 Surgical lamp                                 2
Electrosurgical  878.4810 Laser surgical instrument for use in          2
Cutting                    general and plastic surgery and in
Equipment                  dermatology
                 878.4400 Electrosurgical cutting and coagulation 2
                           device and accessories
Miscellaneous    878.4780 Powered suction pump                          2
                                     113
                                      126                 Initialled on 20 June 1997
 ---pagebreak---                             Financial Statement 1998-2002
                 External trade relations - Mutual Recognition Agreement
1. TITLE
External Trade Relations-
Mutual Recognition Agreements with United States, Canada. Australia, New Zealand and
Israel.
2. BUDGETARY HEADINGS:                  B7-8500
                                       A-7010
3. LEGAL BASIS
• Article 113 of the Treaty of Rome
• Proposal for Council decisions N°.... on the implementation by the European
Commission of mutual recognition agreements with United States, Canada, Australia,
New Zealand and Israel.
4. DESCRIPTION OF OPERATION :
        4.1 General objective:
   The purpose of these agreements is to establish mutual recognition of certification of
   conformity of products with technical regulations or standards of partners to the
   agreement.
   The major actions which will be pursued by the Commission under this budget line
   will be the following:
     •  Confidence-building activities to facilitate the proper implementation of the
        Agreement.
    •   Management of the Agreements and maintenance of the necessary degree of
        confidence.
   The Commission will be assisted by experts, particularly in regard to sectoral
   activities. IIt will however remain the final arbiter in the management of these
   agreements.
        4.2 Duration of the action; means foreseen for its renewal:
   The general action undertaken will be of an indefinite duration. The initial period of
   confidence-building required by the Agreements will require a more intensive effort
   and expenditure, but this should be substantially less after 2 years. However, during the
   life of the Agreements a continued effort will be needed to ensure management and
   maintenance of confidence.
5. CLASSIFICATION OF EXPENDITURE/REVENUE
   5.7 Non-compulsory expenditure ("DNO")
   5.2 Differentiated appropriation ("CD")
   5.3 Type of revenue involved:
   None
                                                    127
 ---pagebreak--- 6. TYPE OF EXPENDITURE/REVENUE
         - 100% subsidy: No
         - subsidy for co-financing with other sources in the public or private sector?
   Yes, this may be envisaged as a method of funding. Subsidies not normally exceeding
   50% will be provided to professional associations and other responsible organisations
   for activities related to the implementation of the Agreement.
        - Interest subsidy: No
        - Others
   Financing of events, acquisition of studies, publications and conferences.
        - Should the action prove an economic success, is there provision for all, or part
            of the Community contribution to be reimbursed?
        Not relevant
        - Will the proposed operation cause any changes in the level of revenue?
        No
7. FINANCIAL IMPACT ON APPROPRIATIONS FOR OPERATIONS
        7.1      Method of calculating the total cost of the operation:
   The estimation of costs is based on the anticipated requirements in terms of expenses
   related to training, seminars, workshops, travel of experts, verification of conformity
   assessment bodies, information and studies. The total estimated cost is based on the
   sum of the individual actions.
   A range of different actions are foreseen to meet the objectives of the budget-line and
   costs will vary depending on the nature of action undertaken. Even for similar types of
   action (e.g. seminars) costs will vary depending on the scope of the action and the
   degree of specialisation needed.
   The costs of specific actions will be determined either:
    •   by the Commission when it organises activities itself, e.g. seminars
    •   following invitations to tender issued by the Commission
    •   following requests for subsidies. In such cases, projects are selected according to
        how well they meet the criteria which have been established for selection.
        Subsidies are based on a percentage of total costs and usually the Community
        funding is limited to a maximum of 50%.
A. Attendance at Joint Committee
     These will be attended by Commission officials and some national experts. Travel
     and per diem expenses should be foreseen within the normal range of such expenses.
                                                 128
 ---pagebreak--- B. Attendance at Joint Sectoral Groups
   These will also be attended by Commission officials and given the nature of these
   meetings a larger contingent of national experts. Travel and per diem expenses
    should be foreseen within the normal range of such expenses.
C. Workshops and Seminars
   These will be held to familiarise economic and other operators with the requirements
   of the Agreement. The cost of these seminars will vary according to the subject
   matter and location, and will include organisational costs (when in Europe) and
   substantial travel costs when in the territory of the partner country. Organisational
   costs in Europe will cost c. 3000 ECUs each. The number of seminars will vary
   depending on the individual industrial sectors covered by the Agreement.
D. Verification actions
   The competence of the conformity assessment bodies (CABs) will in many cases
   have to be checked, more so in the initial period of the Agreement, but as a matter of
   course throughout the life of the Agreement to maintain confidence in the system.
   This will involve on-site assessment by teams of experts of conformity assessment
   bodies in the partner country in the initial stages, and subsequently investigation of
   complaints. This expenditure will be essential in all sectors of the Agreement (... in
   number) and may involve numerous CABs in each sector including at subfederal or
   local level in certain cases.
E. Production and dissemination of information
   Certain costs may need to be incurred for the dissemination of information. Guides to
   regulations and assessment procedures may be needed typically at a cost of 10 000
   ECUs.
                                          129
 ---pagebreak---           7.2      Breakdown by elements of the operation
          "Trade Agreements with important Trading Partners"
          For 1998, this involves the following calculation:
            Budget Heading          Amounts                        Method of calculation
                                      (Ecus)
                                                    No. of missions          Standard Unit cost
           Joint Committee                12 940 Bxl                   2     US: Travel: 2 000 Ecus;
                                                    Bxl                2     per diem: 185 Ecus
           B7-8500                                  Aus / NZ           2
                                                    Israel             1
           Sectoral Groups                57 680 Bxl                 16      CAN: Travel: 1 750
           B7-8500                                  US                 8     Ecus; per diem: 170 Ecus
                                                    CAN                8
           Seminars                      103 540 US                  10      Aus / NZ: Travel: 3 200
                                                    CAN              10      Ecus; per diem: 190 Ecus
           B7-8500                                  Aus/NZ           14
                                                    Bxl              28
                          ;
           Verifications                 142 150 US                  18      Brussels: Travel: 800
                                                    CAN              18      Ecus; perdiem: 110 Ecus
           B7-8500                                  Aus/NZ           12
                                                    Israel            1
           Information                    10 000
           B7-8500
           B7-8500       Total          326 310                     150
                                                                           In Ecus
                                                                           (current prices)
Breakdown                      Year          Year
                               1998          1999          2000          2001          2002       Total
                                                                                                1998-2002
A. Joint Committee               12.940       13 760         12 940         13 760       12 940     66 340
B. Joint Sectoral Groups         57 680       57 680         57 680         57 680       57 680   288 400
C. Seminars                     103 540       96 310                                               199 850
D. Verifications                142 150      142 150         48 430        48 430        48 430   429 590
E. Information                   10 000       10 000         10 000                                 30 000
Total                           326 310      319 900        129 050       119 870       119 050  1014 180
From the year 2000 on the estimates are for information.
                                                     130
 ---pagebreak---          7.3     Indication of the timetable for commitment and payment appropriations
                                                                       1000 Ecus
                          Year                                               2003
                          1998       1999     2000     2001      2002         and         Total
                                                                          following
                                                                            years
    Schedule of         326        319       129      119       119      119            1131
    Commitment
    Payment
    appropriations
    1998                326                                                               326
    1999                           319                                                    319
    2000                                     129                                          129
    2001                                              119                                 119
    2002                                                        119                       119
    2003                                                                 119              119
    Total               326        319       129      119       119      119            1131
8. WHAT ANTI-FRAUD MEASURES ARE PLANNED IN THE PROPOSAL FOR
    THE OPERATION ?
     Methods of control (submission of reports, etc.) will be included in all contracts
     between the Commission and beneficiaries.
     A close cooperation with the delegations of the Commission and the participation of
     a representative of the Commission at events in third countries will check on the spot
     the work to ensure that it corresponds with the terms of reference, contract provisions
     and required professionalism.
     The checks take place before the final payment. The same rule applies to the financial
     incentives paid to participating companies. Where appropriate, agreements also
     require organisations to submit financial accounts certified by their auditors.
     In those eases involving cooperation with EU industrial federations the accounts are
     further checked at the Annual General Meeting of the federations concerned.
9. ELEMENTS OF COST-EFFECTIVENESS ANALYSIS
       9.1. Specific objectives of the proposed operation, population targeted
              - The specific objectives of mutual recognition agreements are:
  •    to avoid duplication of certification by economic operators.
  •    to promote exports, employment, competitivity and investment.
  •    to reduce costs, in particular for small and medium-sized enterprises and ultimately
       for the consumer.
             - Target population
     The target population are the exporting companies, business associations, chambers
     of commerce and public institutions of the European Union and the general consumer
     which will benefit, or have an interest in, the mutual recognition of certification.
                                                 131
 ---pagebreak---        9.2. Reasons for the operation
              - Need for intervention from the Community budget
     Under Article 113 of the Treaty of Rome the Community has exclusive competence
     for commercial policy and these agreements have been negotiated in accordance with
     a mandate of the Council of Ministers and in consultation with the 113 Committee.
     The Commission will be responsible for implementation and management of the
     agreements.
             - Choice of methods of intervention
                * advantages over alternative measures (comparative advantages)
                 * analysis of similar operations at Community or national level
                * results and expected multipliers
The choice of management method (Joint Committee and Joint Sectoral Groups) have
been set out in the Agreements and constitute a minimum necessary for the proper
functioning of the Agreement. The Agreements also contain provisions for the use of
seminars in the initial phases to ensure familiarity with other systems.
These seminars and verifications are also designed to build mutual confidence;
verifications will also be required to ensure this confidence is maintained throughout the
life of the agreements. Confidence and its maintenance are keys to the successful
operation of the agreements.
The importance of this budget is justified when put in perspective with the trade involved
in these agreements and the yearly savings for EU exporters which are- expected
(estimated on a yearly basis at 190 millions ECUs for EU exporters to the US, 20 mio in
the case of exports to Canada and 40 mio in the case of exports to Australia and New
Zealand).
             - Main factors of uncertainty which could affect the specific results of the
                operation.
                * None
       9.3  Monitoring and evaluation of the operation
            - Performance indicators selected
                * Output indicators
                * indicators of impact, following the objectives chosen
   In the case of these Agreements, success can be quantified by trade facilitation through
   avoidance of duplication of testing and certification and costs. Yearly estimated
   savings for the European Community are indicated above (9.2).
   Success can also be measured by increased EU exports and this factor will be taken
   into consideration although export performance is subject to such a wide range of
   variables (e.g. changes in exchange rates) that this can never be the sole factor for
   evaluation.
                                                132
 ---pagebreak---              - Evaluation of results
    Progress in the attainment of the Agreements objectives will be monitored by
    Commission officials, Committees established under the Agreements and by the
    economic operators concerned.
Details and frequency of the planned evaluation
The evaluation of the effectiveness and usefulness of the agreements wil be regularly
monitored by the Commission and by the Committees established under the agreements at
their annual meetings. The first major evaluation will be at the end of the confidence-
building period.
10.     ADMINISTRATIVE EXPENSES
Actual mobilisation of the necessary administrative resources will depend on the
Commission's annual decision on the allocation of resources, taking into account the
number of staff and additional amounts authorised by the budgetary authority. There is no
request for additional staff.
10.1    Effect on the number of posts
         Type of post         Staff to be assigned to                 Source               Duration
                              managing the operation
                          Permanent          Temporary   Existing            Additional
                          posts              posts       resources in the    resources
                                                         DGs or
                               DGI                       departments
                                  +                      concerned
                           sectoral DGs
      Officials        A              .3.5 None                         3.5 None          permanent
                       B
                       C               1                               1
      Other resources     None
      Total                            4.5                             4.5
10.2    Overall financial impact of human resources: 4.5 staff (107 500 Ecus per staff
        member per year = 483 750 Ecus).
10.3    Increase in other administrative expenditure as a result of the operation (A-7010:
        travel expenses)
The expenses set out below relate to travel expenses for officials of the Commission
attending meetings of the Joint Committee, joint sectoral groups, seminars and
verifications, when these are outside Brussels. These will be taken care of by the relevant
budnet allocations of various Directorates Generals involved.
                                                  133
 ---pagebreak--- For 1998 this involves the following calculation:
 Budget heading        Amounts (ECU)                    Method of calculation
                                          No. of missions        Standard Unit cost
Joint Committee                           Aus / NZ           4   US: Travel: 2 000 ECUs;
                                          Israel             4   per diem: 185 Ecus
A-7010                  22 120
Sectoral Groups                           US                4    CAN: Travel: 1 750
                                          CAN               4    Ecus; per diem: 170 Ecus
A-7010                  20 680
Seminars                                  US                4    Aus / NZ: Travel: 3 200
                                          CAN               4    Ecus; per diem: 190 Ecus
A-7010                  20 680            Aus / NZ
Verifications                             US              18
                                          CAN              18
A-7010                142 150             Aus/NZ          12
                                          Israel            1
A-7010       Total    205 630                            73
                                                                    In ECU
                             Year    Year                                       Total
                             1998     1999       2000     2001      2002      1998-2002
       A. Joint
       Committee             22 120  20 680      22 120   20 680    22 120      107 720
       B Joint Sectoral
       Groups                20 680  20 680      20 680   20 680    20 680      103 400
       C. Seminars           20 680  18 260                                      38 940
       D. Verifications     142 150 142 150      48 430  48 430     48 430     429 590
       TOTAL               205 630  201 770      91230   89 790     91230       679 650
                                                1. o ^
 ---pagebreak---                               IMPACT ASSESSMENT FORM
                    THE IMPACT OF THE PROPOSAL ON BUSINESS
                with special reference to small and medium-sized enterprises
Title of proposal
Proposal for a Council Decision on the conclusion of an Agreement between the
European Community and the United States on Mutual Recognition in relation to
Conformity Assessment.
Reference number
The proposal
The legislation is necessary to conclude an Agreement between the European Community
and the United States on Mutual Recognition in relation to Conformity Assessment.
Certificates and Markings. This is an agreement negotiated and initialled by the
Commission in accordance with the mandate and negotiating directives provided by the
Council on 21/9/92.
The impact on business
The business sectors affected are telecommunications terminal equipment, electrical
equipment, recreational craft, medicinal products, and medical devices.
The Agreement permits certification of conformity with technical regulations on product
safety, etc, to be conducted in Europe for exports destined for the United States. This
avoids the necessity for further certification by United States conformity assessment
bodies before putting them oh the United States market.
The Agreement therefore presents important advantages from the point of view of
transparency, market access, avoidance of duplication especially of cost and general
facilitation of trade. This is of particular importance for small and medium-sized
enterprises.
The Agreement covers a wide range of sectors spread throughout the Community and an
extensive range of firms in these sectors both large and small, the advantages are not
limited to specific geographical areas in the Community.
Businesses will have to comply with United States regulations and procedures, but the
certification, as stated above, will be conducted by conformity assessment bodies located
in the Community and designated by the Member States, and not in the United States.
The Agreement will substantially reduce certification costs and improve prospects for
exports, employment, investment and competitiveness by European firms.
The Agreement does not contain measures to take account of the specific situation of
small and medium-sized firms, but by its nature and by reducing certification costs which
are the same for all firms, the agreement will benefit small and medium sized enterprises
to a greater extent proportionately than larger firms.
                                                    _L \} o
 ---pagebreak--- Consultation
The main trade organisations in each sector eg Eurobit, Orgalime, EFPIA have been
consulted and have universally declared their support for the Agreement.
                                                136
 ---pagebreak---                            EU TRADE WITH USA 1995 (MECU)
                    IMPORT                                            EXPORT
lllilHï                      m-         H          Products                  nm         •
 Pharmaceuticals                 1867      1.8     Pharmaceuticals                2216       2.1
 Medical Devices                 2 966     2.9     Medical Devices                 1726      1.7
 Telephonic & Telegraphic        2 000     1.9     Telephonic &                     584      0.6
 Equipment                                         Telegraphic Equipment
Electrical Equipment            14 565    14.1     Electrical Equipment           8 790      8.5
 Recreational Craft                212     0.2   ' Recreational Craft               110      0.1
                     Total     21610      20.9                        Total      13 426     13.0
 TOTAL                        103 644    100.0     TOTAL                        103 284   100.0
                           EU TRADE WITH USA 1996 (MECU)
                    IMPORT                                            EXPORT
WrùÊMim                      Ifll       Hi         Products                  lisp       m
 Pharmaceuticals                 2518      2.2     Pharmaceuticals                2 593      2.3
Medical Devices                  3 509     3.1     Medical Devices                 1770      1.5
Telephonic & Telegraphic         2 869     2.5     Telephonic &                     729      0.6
Equipment                                          Telegraphic Equipment
Electrical Equipment            15 844    14.1     Electrical Equipment           9 793      8.6
 Recreational Craft                216     0.2     Recreational Craft               138      0.1
                     Total     24 956     22.2                        Total      15 024     13.1
TOTAL                         112 624    100.0     TOTAL                        114 309   100.0
 SOURCE:
                   Pharmaceuticals: (ch 30)
                   Medical Devices: (ch 9018, 9019, 9020, 9021, 9022)
                   Telephonic & telegraphic Equipment: (ch 8517)
                   Electrical Equipment: (ch 85)
                   Recreational Craft: (ch 8903)
Source: EUROSTAT (COMEXT)                                         Brussels, 29 October 1997
                                                  137
 ---pagebreak---  ---pagebreak---                                                                   ISSN 0254-1475
                                                           COM(98) 180 final
                                              DOCUMENTS
EN                                                            11 15 16 03
                                    Catalogue number : CB-CO-98-194-EN-C
                                                             ISBN 92-78-32511-2
Office for Official Publications of the European Communities
L-2985 Luxembourg
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