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) 

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. 
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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. 
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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 _ 
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 
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 « 
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 • 
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 
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 
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 
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. Such right of 
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 « 
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& 
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 # 
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 
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 
AGREEMENT ON MUTUAL RECOGNITION 
BETWEEN THE UNITED STATES OF AMERICA AND 
THE EUROPEAN COMMUNITY 
The Government of the United States of America 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 
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 
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. 
Ie ^ Initialled on 20 June 1997 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 
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 years from entry 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 
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 
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 
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 
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 
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 
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 
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 
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: 
EC Authorities identified in Section IV 
shall designate conformity assessment 
bodies located in the EC in accordance with 
the U.S. legislative, regulatory, and 
administrative provisions identified in 
Section I that govern designation of 
conformity assessment bodies, based on 
compliance with the appropriate ISO/IEC 
Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 
6J, etc.) or the comparable EN-45000 Series 
Standards. 
Procedures for designating, listing, 
suspending, withdrawing, and monitoring a 
conformity assessment body listed in 
Section V shall be undertaken pursuant to 
Articles 7, 8, 9, and 10 of the Agreement. U.S. Access to EC Market: 
U.S. Authorities identified in Section IV 
shall designate conformity assessment 
bodies located in the U.S. in accordance 
with the EC legislative, regulatory, and 
administrative provisions identified in 
Section I that govern designation of 
conformity assessment bodies, based on 
compliance with the appropriate EN-45000 
Series Standards or the comparable 
ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 
61, 62, 65, etc.). 
Procedures for designating, listing, 
suspending, withdrawing, and monitoring a 
conformity assessment body listed in 
Section V shall be undertaken pursuant to 
Articles 7, 8, 9, and 10 of the Agreement. 
37 Initialled on 20 June 1997 
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 
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 
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 
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 
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 
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 
US - EC MRA Electromagnetic Compatibility Annex 
SECTION I 
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS 
EC U.S. 
Council Directive 89/336/EEC, as amended by 
Council Directives 91/263/EEC, 92/31/EEC, 
93/68/EEC and 93/97/EEC and 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. Communications Act of 1934. as 
amended by -the Telecommunication Act 
of 1996, (Title 47 of the United States 
Code), 
the U.S. regulatory and administrative 
provisions in respect of equipment subject 
to electromagnetic requirements 
including: 
-47CFRPartl5 
-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 
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 
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: (FA A) 
Greece: 
Ireland: 
Italy: 
Luxemburg: 
Netherlands: 
Portugal: 
Spain: 
Sweden: 
U.K.: 
(list to be completed later) 
46 Initialled on 20 June 1997 
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 
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: 
EC Authorities identified in Section IV 
shall designate conformity assessment 
bodes located in the EC in accordance with 
the U.S. legislative, regulatory^ and 
administrative provisions identified in 
Section I that govern designation of 
conformity assessment bodies, based upon 
compliance with the appropriate ISO/IEC 
Guides (e.g. Guide 22, 25, 28, 58, 61, 62, 
65, etc.) or the comparable EN-45000 
Series Standards. 
Procedures for designating, listing, 
suspending, withdrawing, and monitoring a 
conformity assessment body listed in 
Section V shall be undertaken pursuant to 
Articles 7, 8, 9, and 10 of the Agreement. U.S. Access to EC Market: 
U.S. Authorities identified in Section IV 
shall designate conformity assessment 
bodies located in the U.S. in accordance 
with the EC legislative, regulatory, and 
administrative provisions identified in 
Section I that govern designation of 
conformity assessment bodies, based on 
compliance with the appropriate EN-45000 
Series Standards or the comparable 
ISO/IEC Guides (e.g. Guide 22, 25, 28, 58, 
61, 62, 65, etc.). 
Procedures for designating, listing, 
suspending, withdrawing, and monitoring a 
conformity assessment body listed in 
Section V shall be undertaken pursuant to 
Articles 7, 8, 9, and 10 of the Agreement. 
34 
48 Initialled on 20 June 1997 
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 
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 
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 
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 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. 
O 
fa Initialled on 20 June 1997 
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 
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. 801 fiLsegJ or 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 
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 
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 
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 
57 Initialled on 20 June 1997 
US - EC MRA Electrical Safety Annex 
SECTION V 
CONFORMITY ASSESSMENT BODIES 
EC U.S. 
For EC access to the U.S. market: 
The names and scope of responsibilities of 
Conformity Assessment Bodies located in the EC 
and listed in accordance with this Sectoral Annex: For U.S. access to the EC market: 
The names and scope of responsibilities of 
Conformity Assessment Bodies located in 
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 
58 Initialled on 20 June 1997 
US - EC MRA Electrical Safety Annex 
SECTION VI 
DESIGNATING. LISTING. SUSPENDING AND WITHDRAWING 
CONFORMITY ASSESSMENT BODIES 
EC U.S. 
For EC access to the US. market: 
Conformity assessment bodies from the EC shall 
be designated by the EC Authorities identified in 
Section IV and recognized by the Joint 
Committee, in accordance with the recognition 
procedures in the Agreement and this Annex. 
Conformance with the appropriate ISO/IEC Guides 
or the corresponding EN 4500 series of standards 
shall be deemed consistent with U.S. requirements 
identified in Section I. 
For purposes of designation and listing, EC 
Designating Authorities identified in Section IV 
shall designate conformity assessment bodies 
located in the EC by filing a properly prepared 
proposal for listing, which includes a complete lab 
assessment under the U.S. OSHA procedures. 
OSHA shall notify the EC Designating Authority 
normally within 30 days as to whether the proposal 
is complete or whether additional information is 
required. 
OSHA shall rely on the. EC Designating 
Authorities identified in Section IV for conducting 
on-site reviews at the respective Member States' 
conformity assessment bodies. For U.S. access to the EC market: 
Conformity assessment bodies from the 
U.S. shall be designated by the U.S. 
Authority identified in Section IV and 
recognized by the Joint Committee, in 
accordance with the recognition 
procedures in the Agreement and Council 
Directive 73/23/EEC. 
Conformance with the appropriate EN 
4500 series of standards or the 
corresponding ISO/IEC Guides shall be 
deemed consistent with the requirements 
of Council Directive 73/23/EEC. 
For purposes of designating and listing, the 
U.S. Designating Authority identified in 
Section IV shall designate conformity 
assessment bodies located in the U.S. by 
filing a properly prepared proposal for 
listing with the EC, which includes a 
complete lab assessment under the 
following EC or Member State procedures, 
as appropriate: 
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 
59 Initialled on 20 June 1997 
US - EC MRA Electrical Safety Annex 
SFCT1QN VI f continued^ 
EC U.S. 
Upon receipt of a complete proposal, the U.S. 
exercising its authority under its law shall: 
(a) prior to the 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. The listing of an agreed conformity 
assessment body in Section V of this Sectoral 
Annex shall only occur upon such passage from the 
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. Upon receipt of a complete proposal, the 
EC shall give notice of consent or 
objection to the Joint Committee within 60 
days. The Joint Committee shall monitor 
the recognition of conformity assessment 
bodies and confirm such a recognition by 
listing them in Section V of this Sectoral 
Annex. 
The U.S. conformity assessment bodies 
listed in Section V shall have Notified 
Body status within the EC. 
46 
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US - EC MRA Electrical Safety Annex 
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. 
47 
61 Initialled on 20 June 1997 
US - EC MRA Electrical Safety Annex 
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. 
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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 a framework to 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. 
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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. 
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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. 
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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. 
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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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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. 
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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: 
Belgium: 
Denmark: 
Finland: 
France: 
Germany: 
Greece: 
Ireland: 
Italy: 
Luxembourg: Bundesministerium fur Arbeit, Gesundheit und Soziales, Wien 
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 
Lasgemiddelstyrelsen, Danish Medicines Agency, Bronshoj 
Lââkelaitos/Lâkemedelsverket (National Agency for Medicines), 
Helsinki 
Agence du Médicament, Direction de l'inspection et des 
établissements, Saint Denis (Human) 
Agence Nationale du Médicament Vétérinaire, Fougères (Veterinary) 
Bundesgesundheitsministerium, Bonn 
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 
Ministry of Health and Welfare, National Drug Organisation (E.O.F.), 
Athens 
Irish Medicines Board, Dublin 
Ministero délia Sanità, Dipartimento Farmaci e Farmacovigilanza, 
Roma - (Human) 
Ministero délia Sanità, Dipartimento alimenti e nutrizione e sanità 
pubblica veterinaria - Div. IX, Roma - (Veterinary) 
Direction de la Santé, Division de la Pharmacie et des Médicaments, 
Luxembourg 
The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie voor de 
Gezondheidszorg, Rijswijk 
Instituto da Farmàcia e do Medicamento (INFARMED), Lisboa Portugal: 
Spain: 
Sweden: Ministerio Sanidad y Consumo, Subdirecciôn. General de Control 
Farmacéutico, Madrid (Human) 
Ministerio de Agricultura Pesca y Alimentaciôn, Madrid, (Veterinary) 
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) 
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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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I. APPENDIX 4 
Criteria for Assessing Equivalence for Post- and Pre-Approval 
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 of firm / 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 to firm management. 
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: 
O O Initialled on 20 June 1997 
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 of product 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 of product 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. 
78 
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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 of post-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. 
95 Initialled on 20 June 1997 
US-EC MRA Medical Devices Annex 
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 
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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 
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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 
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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 
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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) 
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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 
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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 
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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 
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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 
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 
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 20 June 1997 
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 
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 
AN 868.5630 NEBULIZER 
CAF - NEBULIZER (DIRECT PATIENT INTERFACE) 
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): 
SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES & 
KTT - APPLIANCE, FIXATION. NAIL/BLADE/PLATE COMBINATION, MULTIPLE OR 888.3030 
ACCESSORIES 
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 
DE 
DE 
DE 
DE 
DE 872.3200 
872.3275 
872.3660 
872.3690 
872.3710 GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR CLINICAL USE 
EJT - ALLOY, GOLD BASED, FOR CLINICAL USE 
EJS - ALLOY, PRECIOUS METAL. FOR CLINICAL USE 
RESIN TOOTH BONDING AGENT 
KLE - AGENT, TOOTH BONDING, RESIN 
DENTAL CEMENT 
EMA - CEMENT. DENTAL 
EMB - ZINC OXIDE EUGENOL 
IMPRESSION MATERIAL 
ELW - MATERIAL, IMPRESSION 
TOOTH SHADE RESIN MATERIAL 
EBF - MATERIAL. TOOTH SHADE, RESIN 
BASE METAL ALLOY 
EJH - METAL. BASE 
Latex Condoms: 
OB 884.5300 CONDOM 
HIS - CONDOM 
95 
108 
Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
TABLE 3 
MEDICAL DEVICES FOR POSSIBLE INCLUSION 
IN SCOPE OF PRODUCT COVERAGE 
DURING OPERATIONAL PERIOD 
Anesthesiology Panel 
Product 
Family Section 
No Device Name Tier 
Anesthesia 
Devices 
-868.5160 
868.5270 
868.5440 
868.5450 
868.5630 
868.5710 
868.5880 Gas machine for anesthesia or analgesia 
Breathing system heater 
Portable oxygen generator 
Respiratory gas humidifier 
Nebulizer 
Electrically powered oxygen tent 
Anesthetic vaporizer 2 
2 
2 
2 
2 
2 
2 
Gas 
Analyser 868.1040 
868.1075 
868.1400 
868.1430 
868.1500 
868.1620 
868.1640 
868.1670 
868.1690 
868.1700 
868.1720 
868.1730 Powered Algesimeter 
Argon gas analyzer 
Carbon dioxide gas analyzer 
Carbon monoxide gas analyzer 
Enflurane gas analyzer 
Halothane gas analyzer 
Helium gas analyzer 
Neon gas analyzer 
Nitrogen gas analyzer 
Nitrous oxide gas analyzer 
Oxygen gas analyzer, 
Oxygen uptake computer 2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
96 
109 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Peripheral 
Nerve 
Stimulators 
Respiratory 
Monitoring 868.2775 
868.1750 
868.1760 
868.1780 
868.1800 
868.1840 
868.1850 
868.1860 
868.1880 
868.1890 
868.1900 
868.2025 
868.2375 
868.2480 
868.2500 
868.2550 
868.2600 
868.5665 
868.5690 Electrical peripheral nerve stimulator 
Pressure plethysmograph 
Volume plethysmograph 
Inspiratory airway pressure meter 
Rhinoanemometer 
Diagnostic spirometer 
Monitoring spirometer 
Peak-flow meter for spirometry 
Pulmonary-function data calculator 
Predictive pulmonary-function value 
calculator 
Diagnostic pulmonary-function 
interpretation calculator 
Ultrasonic air embolism monitor 
Breathing frequency monitor (except 
apnea detectors) 
Cutaneous carbon dioxide (PCCO2) 
monitor 
Cutaneous oxygen monitor (for an infant 
not under gas anesthesia) 
Pneumotachomometer 
Airway pressure monitor 
Powered percussor 
Incentive spirometer 2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
Ventilator 868.5905 
868.5925 
868.5935 
868.5895 
868.5955 
868.6250 Noncontinuous ventilator (IPPB) 
Powered emergency ventilator 
External negative pressure ventilator 
Continuous ventilator 
Intermittent mandatory ventilation 
attachment 
Portable air compressor 2 
2 
2 
2 
2 
2 
97 
110 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Cardiovascular Panel 
Product 
Family Section 
No Device Name Tier 
Cardiovascular 
Diagnostic 870.1425 
870.1450 
870.2310 
870.2320 
870.2340 
870.2350 
870.2360 
870.2370 
870.2400 
870.2450 
870.2675 
870.2840 
870.2860 Programmable diagnostic computer 
Densitometer 
Apex cardiograph (vibrocardiograph) 
B allistocardiograph 
Electrocardiograph 
Electrocardiograph lead switching 
adaptor 
Electrocardiograph electrode 
Electrocardiograph surface electrode 
tester 
Vectorcardiograph 
Medical cathode-ray tube display 
Oscillometer 
Apex cardiographic transducer 
Heart sound transducer 2 
2 
2 
2 
2 
1 
2 
2 
1 
1 
2 
2 
2 
Cardiovascular 
Monitoring 
870.1100 
870.1110 
870.1120 
870.1130 
870.1140 
870.1220 
870.1270 
870.1875 Valve, pressure relief, 
cardiopulmonary bypass 
Blood pressure alarm 
Blood pressure computer 
Blood pressure cuff 
Noninvasive blood pressure 
measurement system 
Venous blood pressure manometer 
Electrode recording catheter or 
electrode recording probe 
Intracavitary phonocatheter system 
Stethoscope (electronic) 2 
2 
2 
2 
2 
2 
2 
2 
98 
111 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
-870.2050 
870.2060 
870.2100 
870.2120 
870.2300 
870.2700 
870.2710 
870.2750 
870.2770 
870.2780 
870.2850 
870,2870 
870.2880 
870.2890 
870.2900 
870.2910 
870.2920 
870.4205 
870.4220 
870.4240 
870.4250 
870.4300 
870.4310 
870.4330 
870.4340 Biopotential amplifier and signal 
conditioner 
Transducer signal amplifier and 
conditioner 
Cardiovascular blood flow-meter 
Extravascular blood flow probe 
Cardiac monitor (including 
cardiotachometer and rate alarm) 
Oximeter 
Ear oximeter 
Impedance phlebograph 
Impedance plethysmograph 
Hydraulic, pneumatic, or photoelectric 
plethysmography 
Extravascular blood pressure transducer 
Catheter tip pressure transducer 
Ultrasonic transducer 
Vessel occlusion transducer 
Patient transducer and electrode cable 
(including connector) 
Radiofrequency physiological signal 
transmitter and receiver 
Telephone electrocardiograph 
transmitter and receiver 
Cardiopulmonary bypass bubble detector 
Cardiopulmonary bypass heart-lung 
machine console 
Cardiovascular bypass heat exchanger 
Cardiopulmonary bypass temperature 
controller 
Cardiopulmonary bypass gas control unit 
Cardiopulmonary bypass coronary 
pressure gauge 
Cardiopulmonary bypass on-line blood 
gas monitor 
Cardiopulmonary bypass level sensing 
monitor and/or control 2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
99 
JL JL r-J Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Cardiovascular 
Therapeutic 870.4370 
870.4380 
870.4410 
870.5050 
870.5900 Roller-type cardiopulmonary bypass 
blood pump 
Cardiopulmonary bypass pump speed 
control 
Cardiopulmonary bypass in-line 
blood 2as sensor 
Patient care suction apparatus 
Thermal regulation system 2 
2 
2 
2 
2 
Defibrillator 870.5300 
870.5325 DC-defribrillator (including paddles) 
Defibrillator tester 2 
2 
Echocardiograph 870.2330 Echocardiograph 2 
Pacemaker & 
Accessories 870.1750 
870.3630 
870.3640 
870.3720 External programmable pacemaker 
pulse generator 
Pacemaker generator function 
analyzer 
Indirect pacemaker generator function 
analyzer 
Pacemaker electrode function tester 2 
2 
2 
2 
Miscellaneous 870.1800 
870.2800 
None Withdrawal-infusion pump 
Medical magnetic tape recorder 
Batteries, rechargeable, class II 
devices 2 
2 
100 
113 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Dental Panel 
Product 
Family Section 
No Device Name Tier 
Dental 
Equipment 872.1720 
872.1740 
872.4120 
872.4465 
872.4475 
872.4600 
872.4840 
872.4850 
872.4920 
872.6070 
872.6350 Pulp tester 
Caries detection device 
Bone cutting instrument and accessories 
Gas-powered jet injector 
Spring-powered jet injector 
Intraoral ligature and wire lock 
Rotary scaler 
Ultrasonic scaler 
Dental electrosurgical unit and 
accessories 
Ultraviolet activator for polymerization 
Ultraviolet detector 2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
Dental 
Material 872.3050 
872.3060 
872.3200 
872.3250 
872.3260 
872.3275 
872.3300 
872.3310 
872.3590 
872.3660 
872,3690 
872.3710 Amalgam alloy 
Gold-based alloys and precious metal 
alloys for clinical use 
Resin tooth bonding agent 
Calcium hydroxide cavity liner 
Cavity varnish 
Dental cement (other than zinc oxide-
eugenol) 
Hydrophilic resin coating for dentures 
Coating material for resin fillings 
Preformed plastic denture tooth 
Impression material 
Tooth shade resin material 
Base metal alloy 2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
101 
114 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
872.3750 
872.3760 
872.3765 
872.3770 
872.3820 
872.3920 Bracket adhesive resin and tooth 
conditioner 
Denture relining, repairing, or rebasing 
resin 
Pit and fissure sealant and conditioner 
Temporary crown and bridge resin 
Root canal filling resin (other than 
chloroform use) 
Porcelain tooth 2 
2 
2 
2 
2 
2 
Dental X-ray 872.1800 
872.1810 Extraoral source x-ray system 
Intraoral source x-ray system 2 
2 
Dental 
Implants 872.4880 
872.3890 Intraosseous fixation screw or wires 
Endodontic stabilizing splint 2 
2 
Orthodontic 872.5470 Orthodontic plastic bracket 2 
Ear/Nose/Throat Panel 
Product 
Family Section 
No Device Name Tier 
Diagnostic 
Equipment 874.1050 
874.1090 
874.1120 
874.1325 
874.1820 Audiometer 
Auditory impedance tester 
Electronic noise generator for 
audiometric testing 
Electroglottograph 
Surgical nerve stimulator/locator 2 
2 
2 
2 
2 
102 
115 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Hearing 
Aids 874.3300 
874.3310 
874.3320 
874.3330 Hearing aid (for bone-conduction) 
Hearing aid calibrator and analysis 
system 
Group hearing aid or group auditory 
trainer 
Master hearing aid 2 
2 
2 
2 
Surgical 
Equipment 874.4250 
874.4490 
874.4500 Ear, nose, and throat electric or 
pneumatic surgical drill 
Argon laser for otology, rhinology, and 
laryngology 
ENT microsurgical carbon dioxide laser 1 
2 
2 
Gastroenterologv/Urologv Panel 
Product Family 
Endoscope 
(including 
angioscopes, 
laparscopes, 
ophthalmic 
endoscopes) Section 
No 
876.1500 
876.4300 Device Name 
Endoscope and accessories 
Endoscopic electrosurgical unit and 
accessories Tier 
2 
2 
Gastroenterology 876.1725 Gastrointestinal motility monitoring 
system 1 
Hemodialysis 876.5600 
876.5630 
876.5665 
876.5820 
876.5830 Sorbent regenerated dialysate 
delivery system for hemodialysis 
Peritoneal dialysis system and 
accessories 
Water purification system for 
hemodialysis 
Hemodialysis system and 
accessories 
Hemodialyzer with disposable insert 
(kiil-type) 2 
2 
2 
2 
2 
103 
116 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Lithotriptor 876.4500 Mechanical lithotriptor 2 
Urology 
Equipment 876.1620 
876.5320 
876.5880 Urodynamics measurement system 
Nonimplanted electrical continence 
device 
Isolated kidney perfusion and transport 
system and accessories 2 
2 
2 
General Hospital Panel 
Product Family Section 
No Device Name Tier 
Infusion Pumps 
and Systems 880.2420 
880.2460 
880.5430 
880.5725 Electronic monitor for gravity flow 
infusion systems 
Electrically powered spinal fluid 
pressure monitor 
Nonelectrically powered fluid injector 
Infusion pump 2 
2 
2 
2 
Neonatal 
Incubators 880.5400 
880.5410 
880.5700 Neonatal incubator 
Neonatal transport incubator 
Neonatal phototherapy unit 2 
2 
2 
Piston Syringes 880.5570 
880.5860 
880.6920 Hypodermic single lumen needle 
Piston syringe (except anti-stick) 
Syringe needle introducer 1 
1 
2 
Miscellaneous 880.2910 
880.2920 
880.5100 Clinical electronic thermometer 
Clinical mercury thermometer 
AC-powered adjustable hospital bed 2 
2 
1 
104 
117 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
880.5500 
880.6880 AC-powered patient lift 
Steam Sterilizer (greater than 2 cubic 
feet) 2 
2 
Neurology Panel 
Product Family Section 
No Device Name Tier 
? 
7 882.1020 
882.1610 Rigidity analyzer 
Alpha monitor 2 
2 
Neuro-Diagnostic 882.1320 
882.1340 
882.1350 
882.1400 
882.1460 
882.1480 
882.1540 
882.1550 
882.1560 
882.1570 
882.1620 
882.1835 
882.1845 
882.1855 
882.5050 Cutaneous electrode 
Nasopharyngeal electrode 
Needle electrode 
Electroencephalograph 
Nystagmograph 
Neurological endoscope 
Galvanic skin response 
measurement device 
Nerve conduction velocity 
measurement device 
Skin potential measurement 
device 
Powered direct-contact 
temperature measurement 
device 
Intracranial pressure 
monitorins device 
Physiological signal amplifier 
Physiological signal 
conditioner 
Electroencephalogram (EEG) 
telemetry system 
Biofeedback device 2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
2 
Echoencephalography 882.1240 Echoencephalograph 2 
105 
118 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
RPG 882.4400 Radiofrequency lesion generator 2 
Neuro 
Surgery none 
882.4305 
882.4310 
882.4360 
882.4370 
882.4560 
882.4725 
882.4845 
882.5500 Electrode, spinal epidural 
Powered compound cranial drills, burrs, 
trephines, and their accessories 
Powered simple cranial drills burrs, 
trephines and accessories 
Electric cranial drill motor 
Pneumatic cranial drill motor 
Stereotaxic instrument 
Radiofrequency lesion probe 
Powered rongeur 
Lesion temperature monitor 2 
2 
2 
2 
2 
2 
2 
2 
2 
Stimulators 882.1870 
882.1880 
882.1890 
882.1900 
882.1950 
882.5890 Evoked response electrical stimulator 
Evoked response mechanical stimulator 
Evoked response photic stimulator 
Evoked response auditory stimulator 
Tremor transducer 
Transcutaneous electrical nerve 
stimulator for pain relief 2 
2 
2 
2 
2 
2 
106 
119 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Obstetrics/Gvnecologv Panel 
Product Family 
Fetal 
Monitoring Section 
No 
884.1660 
884.1690 
884.2225 
884.2600 
884.2640 
884.2660 
884.2675 
884.2700 
884.2720 
884.2740 
884.2960 Device Name 
Transcervical endoscope (amnioscope) 
and accessories 
Hysteroscope and accessories (for 
performance standards) 
Obstetric-gynecologic ultrasonic 
imager 
Fetal cardiac monitor 
Fetal phonocardiographic monitor and 
accessories 
Fetal ultrasonic monitor and 
accessories 
Fetal scalp circular (spiral) electrode 
and applicator 
Intrauterine pressure monitor and 
accessories 
External uterine contraction monitor 
and accessories 
Perinatal monitoring system and 
accessories 
Obstetric ultrasonic transducer and 
accessories Tier 
2 
2 
2 
2 
2 
2 
1 
2 
2 
2 
2 
Gynecological 
Surgery Equip. 884.1720 
884.4160 
884.4550 
884.4120 
884.5300 Gynecologic laparoscope and 
accessories 
Unipolar endoscopic coagulator-cutter 
and accessories 
Gynecologic surgical laser 
Gynecologic electrocautery and 
accessories 
Condom 2 
2 
2 
2 
2 
107 
JL /*, \j Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Product 
Family Section 
No Device Name Tier 
Ophthalm. 
Implants 886.3320 Eye sphere implant 2 
Contact 
Lens 886.1385 
886.5916 Polymethylmethacrylate (PMMA) 
diagnostic contact lens 
Rigid gas permeable contact lens (daily 
wear only) 2 
2 
Diagnostic 
Equipment 
(Diagnostic/ 
Surgery 
Equipment) 886.1120 
886.1220 
886.1250 
886.1360 
886.1510 
886.1570 
886.1630 
886.1640 
886.1670 
886.1780 
886.1850 
886.1930 
886.1945 
886.3130 
886.4670 Opthalmic camera 
Corneal electrode 
Euthyscope (AC-powered) 
Visual field laser instrument 
Eye movement monitor 
Ophthalmoscope 
AC-powered photostimulator 
Ophthalmic preamplifier 
Ophthalmic isotope uptake probe 
Retinoscope (AC-powered device) 
,AC-powered slitlamp biomicroscope 
Tonometer and accessories 
Transilluminator (AC-powered device) 
Ophthalmic conformer 
Phacofragmentation System 2 
2 
1 
2 
2 
Ophthalm. 
Implants 886.3340 
886.3800 Extraocular orbital implant 
Scleral shell 2 
2 
108 
121 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Surgical 
Equipment 880.5725 
886.3100 
886.3300 
886.4100 
886.4115 
886.4150 
886.4170 
886.4250 
886.4335 
886.4390 
886.4392 
886.4400 
886.4440 
886.4610 
886.4690 
886.4790 
886.5100 
none Infusion pump (performance standards) 
Ophthalmic tantalum clip 
Absorbable implant (scleral buckling 
method) 
Radiofrequency electrosurgical cautery 
apparatus 
Thermal cautery unit 
Vitreous aspiration and cutting 
instrument 
Cryophthalmic unit 
Ophthalmic electrolysis unit (AC-
powered device) 
Operating headlamp (AC-powered 
device) 
Ophthalmic laser 
Nd:YAG laser for posterior capsulotomy 
Electronic metal locator 
AC-powered magnet 
Ocular pressure applicator 
Ophthalmic photocoagulator 
Ophthalmic sponge 
Ophthalmic beta radiation source 
Ophthalmoscopes, replacement batteries, 
hand-held 2 
2 
2 
2 
2 
2 
2 
1 
1 
2 
2 
1 
1 
2 
2 
2 
2 
1 
Orthopedic Panel 
Product 
Family Section 
No Device Name Tier 
109 
1 oo 
JL fi*> ,'j Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Implants 888.3010 
888.3020 
888.3030 
888.3040 
888.3050 
888.3060 Bone fixation cerclage 
Intramedullary fixation rod 
Single/multiple component metallic 
bone fixation appliances and accessories 
Smooth or threaded metallic bone 
fixation fastener 
Spinal interlaminal fixation orthosis 
Spinal intervertebral body fixation 
orthosis 2 
2 
2 
2 
2 
2 
Surgical 
Equipment 888.1240 
888.4580 
none 
none 
none 
none, 
none 
none AC-powered dynamometer 
Sonic surgical instrument and 
accessories/attachments 
Accessories, fixation, spinal interlaminal 
Accessories, fixation, spinal 
intervertebral body 
Monitor, pressure, intracompartmental 
Orthosis, fixation, spinal intervertebral 
fusion 
Orthosis, spinal pedicle fixation 
System, cement removal extraction 2 
2 
2 
2 
1 
2 
1 
Physical Medicine Panel 
Product 
Family Section 
No Device Name Tier 
Diagnostic 
Equipment 
or (Therapy) 890.1225 
890.1375 
890.1385 
890.1450 
890.1850 
890.5850 Chronaximeter 
Diagnostic electromyograph 
Diagnostic electromyograph needle 
electrode 
Powered reflex hammer 
Diagnostic muscle stimulator 
Powered muscle stimulator 2 
2 
2 
2 
2 
2 
110 
123 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Therapeutic 
Equipment 890.5100 
890.5110 
890.5500 
890.5720 
890.5740 Immersion hydrobath 
Paraffin bath 
Infrared lamp 
Water circulating hot or cold pack 
Powered heating pad 2 
2 
2 
2 
2 
Radiology Panel 
Product 
Family Section No Device Name Tier 
MRI 892.1000 Magnetic resonance diagnostic device 2 
Ultrasound 
Diagnostic 884.2660 
892.1540 
892.1560 
892.1570 
892.1550 Fetal ultrasonic monitor and 
accessories 
Nonfetal ultrasonic monitor 
Ultrasonic pulsed echo imaging 
system 
Diagnostic ultrasonic transducer 
Ultrasonic pulsed doppler imaging 
system 2 
2 
2 
Angiographic 892.1600 Angiographic x-ray system 2 
111 
124 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Diagnostic 
X-Ray 892.1610 
892.1620 
892.1630 
892.1650 
892.1670 
892.1680 
892.1710 
892.1720 
892.1740 
892.1820 
892.1850 
892.1860 
892.1870 
892.1900 
892.1980 Diagnostic x-ray beam-limiting device 
Cine or spot fluorographic x-ray Camera 
Electrostatic x-ray imaging system 
Image-intensified fluoroscopic x-ray 
system 
Spot film device 
Stationary x-ray system 
Mammographic x-ray system 
Mobile x-ray system 
Tomographic x-ray system 
Pneumoencephalographic chair 
Radiographic film cassette 
Radiographic film/cassestte changer 
Radiographic film/cassette changer 
programmer 
Automatic radiographic film processor 
Radiologic table 2 
2 
2 
2 
2 
2 
2 
2 
1 
2 
1 
1 
2 
2 
1 
CT Scanner 892.1750 Computed tomography x-ray system 
Radiation 
Therapy 
* 892.5050 
892.5300 
892.5700 
892.5710 
892.5730 
892.5750 
892.5770 
892.5840 
892.5930 Medical charged-particle radiation 
therapy system 
Medical neutron radiation therapy 
system 
Remote controlled radionuclide-
applicator system 
Radiation therapy beam-shaping block 
Radionuclide brachytherapy source 
Radionuclide radiation therapy system 
Powered radiation therapy patient 
support assembly 
Radiation therapy simulation system 
Therapeutic x-ray tube housing assembly 2 
2 
2 
2 
2 
2 
2 
2 
1 
112 
125 Initialled on 20 June 1997 
US - EC MRA Medical Devices Annex 
Nuclear 
Medicine 892.1170 
892.1200 
892.1310 
892.1390 Bone densitometer 
Emission computed tomography 
system 
Nuclear tomography system 
Radionuclide rebreathing system 2 
2 
1 
2 
General/Plastic Surgery Panel 
Product Family Section 
No Device Name Tier 
Surgical Lamps 878.4630 
890.5500 
878.4580 Ultraviolet lamp for dermatologic 
disorders 
Infrared lamp 
Surgical lamp 2 
2 
2 
Electrosurgical 
Cutting 
Equipment 878.4810 
878.4400 Laser surgical instrument for use in 
general and plastic surgery and in 
dermatology 
Electrosurgical cutting and coagulation 
device and accessories 2 
2 
Miscellaneous 878.4780 Powered suction pump 2 
113 
126 Initialled on 20 June 1997 
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. I 
agreements. activities. It will however remain the final arbiter in the management of these 
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 
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 
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 
7.2 Breakdown by elements of the operation 
"Trade Agreements with important Trading Partners" 
For 1998, this involves the following calculation: 
Budget Heading 
Joint Committee 
B7-8500 
Sectoral Groups 
B7-8500 
Seminars 
B7-8500 
Verifications ; 
B7-8500 
Information 
B7-8500 
B7-8500 Total Amounts 
(Ecus) 
12 940 
57 680 
103 540 
142 150 
10 000 
326 310 Method of calculation 
No. of missions 
Bxl 2 
Bxl 2 
Aus / NZ 2 
Israel 1 
Bxl 16 
US 8 
CAN 8 
US 10 
CAN 10 
Aus/NZ 14 
Bxl 28 
US 18 
CAN 18 
Aus/NZ 12 
Israel 1 
150 Standard Unit cost 
US: Travel: 2 000 Ecus; 
per diem: 185 Ecus 
CAN: Travel: 1 750 
Ecus; per diem: 170 Ecus 
Aus / NZ: Travel: 3 200 
Ecus; per diem: 190 Ecus 
Brussels: Travel: 800 
Ecus; perdiem: 110 Ecus 
In Ecus 
(current prices) 
Breakdown 
A. Joint Committee 
B. Joint Sectoral Groups 
C. Seminars 
D. Verifications 
E. Information 
Total Year 
1998 
12.940 
57 680 
103 540 
142 150 
10 000 
326 310 Year 
1999 
13 760 
57 680 
96 310 
142 150 
10 000 
319 900 2000 
12 940 
57 680 
48 430 
10 000 
129 050 2001 
13 760 
57 680 
48 430 
119 870 2002 
12 940 
57 680 
48 430 
119 050 Total 
1998-2002 
66 340 
288 400 
199 850 
429 590 
30 000 
1014 180 
From the year 2000 on the estimates are for information. 
130 
7.3 Indication of the timetable for commitment and payment appropriations 
1000 Ecus 
Schedule of 
Commitment 
Payment 
appropriations 
1998 
1999 
2000 
2001 
2002 
2003 
Total Year 
1998 
326 1999 
319 2000 
129 2001 
119 2002 
119 2003 
and 
following 
years 
119 Total 
1131 
326 
326 319 
319 129 
129 119 
119 119 
119 119 
119 326 
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 
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 
- 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 
Officials A 
B 
C 
Other resources 
Total Staff to be assigned to 
managing the operation 
Permanent 
posts 
DGI 
+ 
sectoral DGs 
.3.5 
1 
None 
4.5 Temporary 
posts 
None Source 
Existing 
resources in the 
DGs or 
departments 
concerned 
3.5 
1 
4.5 Additional 
resources 
None Duration 
permanent 
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 
For 1998 this involves the following calculation: 
Budget heading 
Joint Committee 
A-7010 
Sectoral Groups 
A-7010 
Seminars 
A-7010 
Verifications 
A-7010 
A-7010 Total Amounts (ECU) 
22 120 
20 680 
20 680 
142 150 
205 630 Method of calculation 
No. of missions 
Aus / NZ 4 
Israel 4 
US 4 
CAN 4 
US 4 
CAN 4 
Aus / NZ 
US 18 
CAN 18 
Aus/NZ 12 
Israel 1 
73 Standard Unit cost 
US: Travel: 2 000 ECUs; 
per diem: 185 Ecus 
CAN: Travel: 1 750 
Ecus; per diem: 170 Ecus 
Aus / NZ: Travel: 3 200 
Ecus; per diem: 190 Ecus 
In ECU 
A. Joint 
Committee 
B Joint Sectoral 
Groups 
C. Seminars 
D. Verifications 
TOTAL Year 
1998 
22 120 
20 680 
20 680 
142 150 
205 630 Year 
1999 
20 680 
20 680 
18 260 
142 150 
201 770 2000 
22 120 
20 680 
48 430 
91230 2001 
20 680 
20 680 
48 430 
89 790 2002 
22 120 
20 680 
48 430 
91230 Total 
1998-2002 
107 720 
103 400 
38 940 
429 590 
679 650 
1 . o ^ 
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 
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 
EU TRADE WITH USA 1995 (MECU) 
IMPORT EXPORT 
lllilHï m- H Products nm • 
Pharmaceuticals 
Medical Devices 
Telephonic & Telegraphic 
Equipment 
Electrical Equipment 
Recreational Craft 
Total 
TOTAL 1867 
2 966 
2 000 
14 565 
212 
21610 
103 644 1.8 
2.9 
1.9 
14.1 
0.2 
20.9 
100.0 Pharmaceuticals 
Medical Devices 
Telephonic & 
Telegraphic Equipment 
Electrical Equipment 
' Recreational Craft 
Total 
TOTAL 2216 
1726 
584 
8 790 
110 
13 426 
103 284 2.1 
1.7 
0.6 
8.5 
0.1 
13.0 
100.0 
EU TRADE WITH USA 1996 (MECU) 
IMPORT EXPORT 
WrùÊMim Ifll Hi Products lisp m 
Pharmaceuticals 
Medical Devices 
Telephonic & Telegraphic 
Equipment 
Electrical Equipment 
Recreational Craft 
Total 
TOTAL 2518 
3 509 
2 869 
15 844 
216 
24 956 
112 624 2.2 
3.1 
2.5 
14.1 
0.2 
22.2 
100.0 Pharmaceuticals 
Medical Devices 
Telephonic & 
Telegraphic Equipment 
Electrical Equipment 
Recreational Craft 
Total 
TOTAL 2 593 
1770 
729 
9 793 
138 
15 024 
114 309 2.3 
1.5 
0.6 
8.6 
0.1 
13.1 
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 

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 
138