Source: https://tcc.export.gov/Trade_Agreements/All_Trade_Agreements/US_EU_AG_mutual_recognition.asp
Timestamp: 2018-10-20 17:50:04
Document Index: 776623492

Matched Legal Cases: ['art 68', 'art 68', 'art 20', 'art 21', 'art 22', 'art 24', 'art 73', 'art 74', 'art 78', 'art 80', 'art 80', 'art 90', 'art 94', 'art 95', 'art 95', 'art 97', 'art 15', 'arts\n1', 'arts 200', 'arts 500', 'arts 600', '§ 201', 'arts 800']

The EUROPEAN COMMUNITY, and the GOVERNMENT OF THE UNITED STATES OF
AMERICA, hereinaffer 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);
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,
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.
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.
Designating Authority means a body with power to designate, monitor, suspend,
remove suspension of, or withdraw conformity assessment bodies as specified
Designation means the identification by a Designating Authority of a conformity
assessment body to perform conformity assessment procedures under this
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
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,
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.
1. 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.
2. 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.
3. 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
appMcable legislative, regulatory and administrative provisions of that Party, equivalent
to the assurance offered by the receiving Party's own procedures.
1. This Agreement applies to conformity assessment procedures for products and/or
processes and to other related cooperative activities as described in this Agreement.
(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
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.
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.
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.
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;
(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.
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
(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;
(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.
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;
withdrawal from the list in the Sectoral Annex of the conformity assessment body
(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.
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
(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
(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.
Each Party recognizes that the conformity assessment bodies listed in the Sectoral
Annexes fulfil 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.
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.
Each Party shall appoint and confirm in writing contact points to be responsible for
activities under each Sectoral Annex.
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
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
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
(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
Commiftees;
(d) providing a forum for discussion of issues that may arise concerning the
(e) considering ways to enhance the operation of this Agreement;
(f) coordinating the negotiation of additional Sectoral Annexes; and
(g) considering whether to amend this Agreement or its Sectoral Annexes in
accordance with Article 21.
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.
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 fall 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.
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 fulfil its obligations
(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
(c) the other Party falls to maintain legal and regulatory authorities capable of
implementing the provisions of this Agreement.
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.
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.
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.
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.
1. This Agreement including its Sectoral Annexes on Telecommunication Equipment,
Electromagnetic Compatibility, Electrical Safety, Recreational Craft, Pharmaceutical
Good Manufacturing Practices (GMPs), 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
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 if 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 from the date of notice.
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
1. The Sectoral Annexes referred to in Article 21(l), 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
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,
U.S. - EC MRA Telecommunication Equipment Annex
SECTORAL ANNEX
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of
Conformity Assessment between the United States and the European Community.
EC U.S.
Directive 98/13/EC of the European Parliament
and of the Council of 12 February 1998 relating to telecommunications terminal equipment
and satellite earth station equipment, including
the mutual recognition of their conformity, and interpretation thereof
(The Parties recognize that the Handbook on the implementation of Directive 98/13/EC (ADLNB and ACTE approved), provides useful guidelines for the implementation of conformity assessment procedures falling under this Directive,);
The EC Member Slates' legislation and regulations in respect of:
(a) non-harmonized analogue connection
to the public telecommunications
network*;
(b) non-harmonized radio transmitters for
which there is a civilian equipment
authorization requirement;
*The EC agrees to seek authority to
include non-harmonized digital
For electrical safety, see Electrical Safety
Sectoral Annex to the Agreement;
For electromagnetic compatibility aspects, see
Electromagnetic Compatibility (EMC) Sectoral
the U.S. regulatory and administrative provisions
in respect of telecommunication equipment,
including 47 CFR Part 68, and FCC
(The Parties recognize that the FCC Form 730 Application Guide provides useful guidelines for the implementation of conformity assessment procedures for telecommunication terminal equipment falling within these regulations,);
The U.S. regulatory and administrative provisions in respect of all radio transmitters
subject to an equipment authorization requirement. A non-exclusive list of FCC regulations are contained in Section II;
1. This Sectoral Annex shall apply to equipment, interfaces, and services subject to
Section 1. In general terms the provisions of this Sectoral Annex shall apply to the
following types of telecommunication 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
2. The following is a non-exclusive list of the equipment, interfaces, and services
included within the scope of this Sectoral Annex:
The following equipment categories are included :
ONP Leased Line Terminal types :
2048 kbits/s unstructured
2048 kbits/s structured
34 Mbits/s access
Radio transmitters subject to an equipment authorization requirement, including:
(List to be provided before signing of Sectoral Annex.)
Equipment categories covered under 47 CFR Part 68, including:
Digital Service Access :
2 wires analog tie trunks/ops
4 wire analog tie trunks/ops
PSTN Voice Band (Analog) Access
Commercial Mobile Radio (Part 20)
Domestic Public Fixed(Part 21)
Domestic Mobile (Part 22)
Personal Communication Service(Part 24)
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)
Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral
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 1.
Taking into account the legislative, regulatory, and administrative provisions as
identified in Section 1, 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 telecommunication
terminal equipment, satellite terminal equipment, radio transmitters or information
(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 Directive 98/13/EC.
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE
CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
Institut belge des services postaux et des
Belgisch instituut voor postdiensten en
Ministry of Transport & Communications.
Ministère de l'économie, des finances et de
Deptartment of Transport, Energy & Communications.
Ispettorato General TLC.
Administration des Postes et
Bundesministerium für Wissenschaft,Verkehr
und Lumst.
Instituto das Communicações.
Sweden: Styrelsen för ackreditering och teknisk
kontroll (SWEDAC)
(to be provided by the EC upon notification by the Member States).
Conformity assessment bodies located in the U.S. shall be designated by the Authorities identified in Section IV following the procedures set out in Section VI of this Annex.
DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING
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, 65, etc.) or the comparable EN-45000 Series Standards.
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.).
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.
2.1. For the purpose of post-market surveillance, the Parties may maintain any existing
labelling 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 labelling 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, labelled 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 favourable manner than for like-domestic goods.
3.1. A combined Joint Sectoral Committee for this Sectoral Annex and the
Electromagnetic Compatibility (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
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
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
(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
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.
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.
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
(b) to initiate regulatory changes needed to support the objectives of the
(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
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
(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
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
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
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.
ACTE Approvals Committee for Terminal Equipment
ADLNB Association of Designated Laboratories and Notified Bodies
CFR U.S. Code of Federal Regulations, Title 47 CFR
EN Norme Europeenne (European Standard)
IVIS Member States (of the European Union)
NB Notified Bodies
OJ Official Journal (of the European Union)
STG Sectoral Technical Group for Telecommunications
X21 ITU-T Recommendation X21
X25 ITU-T Recommendation X25
U.S. - EC MRA Electromagnetic Compatibility Annex
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 telecommunication equipment and radio transmitters, see also Telecommunications Equipment Sectoral Annex to the Agreement.
the U.S. regulatory and administrative provisions in respect of equipment subject to electromagnetic requirements including:
For US access to the EU market:
For EU access to the US market:
FOR EQUIPMENT IDENTIFIED IN SECTION 11
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 1.
identified in Section 1, 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 11:
applicable in the territories of the Parties for products covered under this
Ministerle van Economische Zaken
Danmarks Elektriske Materlelkontrol
Ministero dell'Industria, del Commercio e dell'
Instituto Português das Communicações de Portugal
Kauppa-ja teollisuusministeriö/Handels-och
For EC access to the U.S. market:
For U.S. access to the EC market:
DESIGNATING, LISTING, SUSPENDING, WITHDRAWING
AND MONITORING CONFORMITY ASSESSMENT BODIES
LISTED IN SECTION V
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.
I . SUB-CONTRACTING
1.2. The conformity assessment bodies shall record and retain details of its
investigation of the competence and compliance of its sub-contractors and
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.
been certified, labeled or marked as conforming with the importing Party's
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,
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
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.
arise concerning the implementation of this Sectoral Annex;
legislation, regulations, standards, and conformity assessment procedures;
(c) advising the Parties on matters relating to this Sectoral Annex;
transitional period to facilitate the successful completion of the transitional
inquiries from the other Party regarding procedures, regulations and complaints
In the event that there are changes to the legislative, regulatory and
legislative, regulatory and administrative provisions affecting either Party's
effect domestically within the territory of each Party. The Parties shall update this
Sectoral Annex to reflect the changes.
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.
(a) to consider new legislative changes needed to support the objectives of the
(e) to monitor and evaluate the performance of the listed conformity assessment
bodies during the transitional period.
conformity, the dossiers are promptly examined for completeness,
(c) any request for additional information is limited to omissions, inconsistencies or
variances from the technical regulations or standards;
(d) procedures for assessing the conformity for equipment modified subsequent
to a determination of compliance, are limited to procedures necessary to
determine continued conformance.
Each Party ensures that issuance of approvals, certificates or advice to the
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.
U.S. - EC MRA Electrical Safety Annex
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition
between the United States and the European Community.
Council Directive 73/23/EEC of 19 February 1973 as amended by 93/68/EEC.
For telecommunications equipment, see the Telecommunications Equipment Sectoral Annex to this Agreement.
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 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.
OSHA will consider regulatory and legislative changes needed to support the objectives of the MRA.
The electrical safety requirements of products falling under the scope of Council Directive 73/23/EEC on the harmonization of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits.
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 Notionally Recognised Testing Laboratory (NRTQ 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,"
EC access to the U.S. market: U.S. access to the EC market:
Department of Enterprise and
Ministero dell'Industria, del Commercio e
Under the authority of the Government of Portugal
The names and scope of responsibilities of Conformity Assessment Bodies located in the U.S. and listed in accordance with this Sectoral Annex:
DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING
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.
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.
SECTION VI (continued)
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.
EC conformity assessment bodies listed in Section V shall have NRTL status in the U.S.
The U.S. conformity assessment bodies listed in Section V shall have Notified Body status within the EC.
JOINT SECTORAL COMMITTEE FOR ELECTRICAL SAFETY
1. The Joint Sectoral Committee for Electrical Safety (JSC/ES) consists of
representatives of the U.S. and the EC, OSHA 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.
2. 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
providing a forum for discussion of issues that may arise concerning the
implementation of this Sectoral Annex;
U.S. - EC MRA Recreational Craft Annex
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 18 months is arranged to build
confidence as defined in this Sectoral Annex, Section VI.
LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE
1. For the European Community:
Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994
on the approximation of the laws, regulations, and administrative provisions of the
Member States relating to recreational craft,
46 U.S.C. Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.
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
2. The product coverage for each Party shall be determined by the following relevant
(a) for the European Community:
Recreational craft as defined in Directive 94/25/EC.
(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 CFIR 58.
3. 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/EC, 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
(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.
AUTHORITIES RESPONSIBLE FOR DESIGNATING
THE CONFORMITY ASSESSMENT BODIES
MInIsterle van Verkeer en Infrastructuur
Ministere de I'Equipment, des Transports et du Logement
MInistere de I'Economie, des Finances et de I'Industrie
Ministero dell'Industria, del Commerclo e dell'
Merenkulkuhallitus/sjofartsstyrelsen
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 set out in Section V 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/EC, are deemed to be in compliance with U.S.
(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 V 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.
The names and scope of responsibilities The names and scope of responsibilities
of Conformity Assessment Bodies located in the Conformity Assessment Bodies
EC and listed in accordance with this located in the U.S. and listed in
Sectoral Annex: accordance with this Sectoral Annex:
(to be provided by EC) (to be provided by the US)
1. There shall be a transitional period of 18 months prior to the operations of this
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
(b) carry out or recommend any applicable policy, legislative and regulatory
changes necessary for the provisions of this Annex.
All products covered by Section 11 of this Annex.
During this transitional period, both Parties shall endeavour to jointly sponsor
seminars for the purpose of improving the understanding of technical
specifications applicable in each Party's jurisdiction.
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.
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.
Notified Body means a third party authorized to perform the conformity assessment
tasks specified in Directive 94/25/EC, 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/EC and has been
notified to the Commission and to the other Member States.
U.S. - EC MRA Pharmaceutical Good Manufacturing Practices Annex
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 thiot 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" (GMPs): (The U.S. and EC have agreed to revisit
these concepts)
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
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 EQ.
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.
The provisions of this Annex govern the exchange between the Parties and normal
endorsement by the receiving authority of official Good Manufacturing Practices
(GMPs) 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
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 GMPs requirements,
Appendix 2 lists the authorities participating in activities under this Annex,
These provisions will apply to medicinal products for human or animal use,
intermediates and starting materials (as referred to in the EQ 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 Biologics Evaluation and Research as devices are
not covered under this Annex.
A three-year transition period will start immediately after the effective date of the
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
2. The authorities of the parties will establish and communicate to each other their
draft programmes for assessing the equivalence of the respective regulatory
systems in terms of quality assurance of the products and consumer protection.
These programmes will be carried out, as deemed necessary by the authorities,
for post- and pre-approval inspections and for various product classes or
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
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
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.
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).
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.
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
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 Food and Drug Administration
(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.
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.
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 endeavour 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.
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
within 90 calendar days of the request.
A preliminary notification that an inspection may have to take place will be made as
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.
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.
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.
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-chalred by a representative of FDA for the U.S. and a
representative of the EC who each will have one vote. Decisions will be taken by
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
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.
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 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.
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.
Each Party recognizes that the importing country has a right to fulfil 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.
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
Council Directive 81/851 /EEC of 28 September 1981 on the approximation of the laws
of the Member States relating to veterinary medicinal products, as widened and
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 (EEC) No 2309/93 of 22 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
Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of
Current version of the Guide to Good Manufacturing Practice, Rules Governing
Medicinal Products in the European Community, Volume IV.
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.
BELGIUM: Inspection générale de la Pharmacie
DENMARK: Laegemiddelstyrelsen
for immunologicals:
Paul-Ehrlich-Institut, Federal Agency for Sera & Vaccines
National Drug Organization (E.O.F.)
SPAIN: for medicinal products for human use:
Ministerio de Agricultura, Pesca y Allmentación (MAPA)
FRANCE: for medicinal products for human use:
ITALY: for medicinal products for human use:
Dipartimento alimenti e nutrizione e sanita pubblica
veterinaria Div. IX
LUXEMBOURG: Division de la Pharmacie et des Médicaments
NETHERLANDS: Stoat der Nederlanden
AUSTRIA: Bundesministerium für Arbeit, Gesundheit und Soziales
PORTUGAL: Instituto da Farmáci a e do Medicamento INFARMED
FINLAND: Lääkelaitos/Läkemedelsverket
SWEDEN: Läkemedelsverket Medical Products Agency
UNITED KINGDOM: for human and veterinary (non-immunologicals):
EUROPEAN COMMUNITY: Commission of the European Communities
Recognizing that precise definition of medicinal products and drugs are to be found in
the legislation 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).
Criteria for Assessina Eaulvalence for Post- and Pre-Approval
1. Legal/Regulatory authority and structures and procedures providing for post- and
B. Ability to issue and update binding requirements on GMPs and guidance
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,
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
A. Standards of education /qualification and training.
B. Effective quality assurance systems measures to ensure adequate job
A. Adequate pre-inspection preparation, including appropriate expertise of
investigator/team, review of firm/product and databases, and availability of
appropriate inspection equipment.
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.
E. Verification of approved manufacturing process changes to marketing
authorizations/approved applications.
VII. AdditionaI 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
F. Review and evaluate equipment installation, operational and performance
qualification data, and evaluate test method validation.
I . Documentation
Definition of a crisis/emergency and under what circumstances an alert is
Mechanism of health hazards evaluation and classification
Language of communication and transmission of information
Crisis analysis and communication mechanisms
Pharmacovigilance programme
Surveillance/monitoring of implementation of corrective action
the Executive Director of the European Agency for the Evaluation of Medicinal
Products, 7, Westferry Circus, Canary Wharf, UK London E14 4B, England.
Telephone +44-171-418 8400, Fax 418 8416.
U.S. - EC MRA Medical Devices Annex
SECTORAL ANNEX ON
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in
Relation to Conformity Assessment between the United States and the European
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.
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 programmes 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 Food and Drug
Administration (FDA) and EC policies evolve over time.
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
(a) Under the U.S. system, surveillance/post-market and initial/pre-approval
(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
(a) products are regulated as medical devices by each Party;
(b) CABs are designated and confirmed; and
(c) these reports are prepared.
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.
There are three components to this agreement each covering a discrete range of
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 (51O(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 1/Class 11 Tier 2 medical devices which
are listed in Appendix 2.
3. Post-Market Viallance Reports Post-market vigilance reports will be exchanged
with regard to all products regulated under both U.S. and EC law as medical
Additional products and procedures may be made subject to this Annex by
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.
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.
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.
1. At the beginning of the transitional period, the Joint Sectoral Group will establish
joint confidence building programme 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
(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
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.
1. During the transition period, the Parties will jointly determine the necessary
information which must be present in quality system and product evaluation
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.
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 16.
3. Decisions concerning the equivalence of CABs must be agreed to by both
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
1 Listed EC CABs will provide FDA with reports of quality system evaluations, as
(a) For pre-approval quality system evaluations, EC CABs will provide full reports;
(b) For surveillance quality system evaluations, EC CABs will provide abbreviated
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.
4. 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 endeavour 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.
1. EC CABs listed for this purpose will, subject to the specifications and limitations on
the list, provide to the FDA 51 O(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 endeavour to respond to requests for clarification in
a timely manner. Endorsement remains the responsibility of the importing Party.
Quality system evaluation reports covered by Article I I 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.
Transmission of product evaluation reports will take place according to the importing
Party's specified procedures.
Monitoring activities will be carried out in accordance with Article 10 of the
1. During the operational period, 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.
I 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
(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 and 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
(d) consideration of the issue of suspension.
HARMONIZATION AND INFORMATION EXCHANGE
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
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
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
ddnger 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.
1 . For the European Community the following legislation applies to Article 2(1):
(a) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the
laws of the Member States relating to active implantable medical devices.
*Annex II (with the exception of section 4)
*Annex IV
*Annex V
(b) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
*Annex III
*Annex VI
2. For the United States, the following legislation applies to Article 2(1):
(a) The Federal Food, Drug and Cosmetic Act, 21 U.S.C. ÿ§ÿ§ _321 et seq.
(b) The Public Health Service Act, 42 U.S.C. ÿ§ÿ§ 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).
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
(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
(1) It is understood that the date of entry into force will not occur prior to 1 June 1998,
unless the Parties decide otherwise.
(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
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.
CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS
IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT COVERAGE
AT BEGINNING OF TRANSITION PERIOD
Section Regulation Name
No. Product Code Device Name
BZW El STETHOSCOPE, ESOPHAGEAL
BYP HI MOUTHPIECE, BREATHING
CCQ NEBULIZER, MEDICINAL, NON-VENTILATORY
(ATOMIZER)
BYW DEVICE, REBREATHING
FOG HOOD, OXYGEN, INFANT
BYL TENT, OXYGEN
BSY CATHETERS, SUCTION, TRACHEOBRONCHIAL
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)
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
EKY 2 HANDPIECE, WATER-POWERED
872.6640 DENTAL OPERATIVE UNIT
EIA UNIT, OPERATIVE DENTAL
ETR ADAPTER, SHORT INCREMENT SENSITIVITY INDEX (SISI)
ETM GUSTOMETER
KHH STIMULATOR, CALORIC-AIR
ETP STIMULATOR, CALORIC-WATER
ETK TUBE, TOYNBEE DIAGNOSTIC
LRB FACE PLATE HEARING-AID
ESD HEARING-AID, AIR-CONDUCTION
EMX BALLOON, EPISTAXIS
ETF UNIT, EXAM IN ING/TREATM ENT, ENT
KMA IRRIGATOR, POWERED NASAL
874.5840 ANTI-STAMMERING DEVICE
KTH DEVICE, ANTI-STAMMERING
GASTROENTEROLOGY 5il UROLOGY PANEL (876)
876.5160 UROLOGICAL CLAMPS FOR MALES
FHA CLAMP, PENILE
FCE KIT, ENEMA, (FOR CLEANING PURPOSE)
FAQ BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE
FOK PAD, NEONATAL EYE
880.5420 PRESSURE INFUSER FOR I.V. BAG
KZD INFUSOR, PRESSURE, FOR I.V, BAGS
FRP HOLDER, INFANT POSITION
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
KMJ LUBRICANT, PATIENT
BRT RESTRAINT, PATIENT, CONDUCTIVE
FMQ RESTRAINT, PROTECTIVE
GWW ATAXIAGRAPH
882.1420 ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM
GWS El ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM
HCD El CANNULA, VENTRICULAR
GYK INSTRUMENT, SHUNT SYSTEM IMPLANTATION
HAS 2 NEEDLE, NEUROSURGICAL SUTURE
GXJ PUNCH, SKULL
HKM RETINOSCOPE, BATTERY-POWERED
HKZ STERILIZER, TONOMETER
HQS BURR, CORNEAL, AC-POWERED
HOG BURR, CORNEAL, BATTERY-POWERED
HRG ENGINE, TREPHINE, ACCESSORIES, AC-POWERED
HFIR ENGINE, TREPHINE, ACCESSORIES, BATTERY-POWERED
HILD ENGINE, TREPHINE, ACCESSORIES, GAS-POWERED
886.4300 KERATONE
HNO KERATONE, AC-POWERED
HMY KERATONE, BATTERY-POWERED
886.5850 SUNGLASSES (NON-PRESCRIPTION)
HQY SUNGLASSES (NON-PRESCRIPTION INCLUDING
PHOTOSENSITIVE)
888.1500 AC-POWERED GONIOMETER
KQX GONIOMETER, AC-POWERED
888.4150 CALLIPERS FOR CLINICAL USE
KTZ CALLIPER
LBE STROLLER, ADAPTIVE
IOR WHEELCHAIR, MECHANICAL
INY BED, PATIENT ROTATION, MANUAL
890.5710 HOT OR COLD DISPOSABLEPACK
IMD PACK HOT OR COLD, DISPOSABLE
892.1100 SCINTILLATION GAMMA CAMERA
IYX CAMERA, SCINTILLATION (GAMMA)
IZC CAMERA, POSITRON
IYW SCANNER, RECTILINEAR, NUCLEAR
IZD PROBE, UPTAKE, NUCLEAR
JAM SCANNER, WHOLE BODY, NUCLEAR
IVY El SYNCHRONIZER, ELECTROCARDIOGRAPH, NUCLEAR
892.1890 RADIOGRAPHIC-FILM ILLUMINATOR
IXC ILLUMINATOR, RADIOGRAPHIC-FILM
JAG ILLUMINATOR, RADIOGRAPHIC-F[CM,
IXJ GRID, RADIOGRAPHIC
WAM SCREEN, INTENSIFYING, RADIOGRAPHIC
IXO SYNCHRONIZER, ECG/RESPIRATOR, RADIOGRAPHIC
IWG SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL
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
JCY CATHETER, INFUSION
GBP CATHETER, MULTIPLE LUMEN
GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC
GBN CATHETER, PEDIATRIC, GENERAL & PLASTIC SURGERY
GBW CATHETER, PERITONEAL
GBS CATHETER, VENTRICULAR, GENERAL & PLASTIC
GCD CONNECTOR, CATHETER
GCC DILATOR, CATHETER
GCB NEEDLE, CATHETER
FZQ CLIP, REMOVABLE (SKIN)
KGO SURGEON'S GLOVES
878.4680 NONPOWERED, SINGLE PATIENT, PORTABLE SUCTION
GCY APPARATUS, SUCTION, SINGLE PATIENT USE,
PORTABLE, NONPOWERED
GDT STAPLE, REMOVABLE (SKIN)
GENERAL AND PLASTIC SURGERY PANEL (878) (CONTINUED)
878.4820 AC-POWERED, BATTERY-POWERED, AND PNEUMATICALLY
POWERED SURGICAL INSTRUMENT MOTOR
GFG BIT, SURGICAL
GFA BLADE, SAW, GENERAL AND PLASTIC SURGERY
DWH BLADE, SAW, SURGICAL CARDIOVASCULAR
BRZ BOARD, ARM (WITH COVER)
GFE BRUSH, DERMABRASION
GFF BUR, SURGICAL, GENERAL AND PLASTIC SURGERY
KDG CHISEL (OSTEOTOME)
GFD DERMATOME
GFC DRIVER, SURGICAL, PIN
GFB HEAD, SURGICAL, HAMMER
GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED
GET MOTOR, SURGICAL INSTRUMENT, PNEUMATIC
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 AND 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,
KMF BANDAGE, LIQUID
CLASS 11 MEDICAL DEVICES INCLUDED
IN SCOPE OF PRODUCT COVERAGE
U.S. to develop guidance documents identifying U.S, requirements and EC to identify
standards needed to meet EC requirements
MOS COIL MAGNETIC RESONANCE, SPECIALTY
LNH SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
LNI SYSTEM, NUCLEAR MAGNETIC RESONANCE
JAF MONITOR, ULTRASONIC, NONFETAL
IYN SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
IZI SYSTEM, X-RAY, ANGIOGRAPHIC
MQB SOLID STATE X-RAY IMAGER (FLAT PANEUDIGITAL
JAA SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
KPR SYSTEM, X-RAY, STATIONARY
IZL SYSTEM, X-RAY, MOBILE
IZF SYSTEM, X-RAY, TOMOGRAPHIC
JAK SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
DIPS ELECTROCARDIOGRAPH
MLC MONITOR, ST SEGMENT
DRW ADAPTOR, LEAD SWITCHING, ELECTROCARDIOGRAPH
DRX ELECTRODE, ELECTROCARDIOGRAPH
KRC TESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC
GWQ ELECTROENCEPHALOGRAPH
MRZ ACCESSORIES, PUMP, INFUSION
FRN PUMP, INFUSION
LZF PUMP, INFUSION, ANALYTICAL SAMPLING
MEB PUMP, INFUSION, ELASTOMERIC
MHD PUMP, INFUSION, GALLSTONE DISSOLUTION
LZG PUMP, INFUSION, INSULIN
MEA PUMP, INFUSION, PCA
HLI OPHTHALMOSCOPE, AC-POWERED
HLJ OPHTHALMOSCOPE, BATTERY-POWERED
HKL RETINOSCOPE, AC-POWERED
HJO BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
MMC DILATOR, EXPANSIVE IRIS (ACCESSORY)
HQE INSTRUMENT, VITREOUS ASPIRATION AND CUTTING,
HKP INSTRUMENT, VITREOUS ASPIRATION AND CUTTING,
MLZ VITRECTOMY, INSTRUMENT CUTTER
HQC UNIT, PHACOFRAGMENTATION
HBI ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
FTF ILLUMINATOR, NON-REMOTE
FTG ILLUMINATOR, REMOTE
HJE LAMP, FLUORESCENT, 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
FSQ LIGHT, SURGICAL, INSTRUMENT
NE 882.5890 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN
GZJ STIMULATOR, NERVE, TRANSCUTANEOU'S, FOR PAIN RELIEF
DXQ CUFF, BLOOD-PRESSURE
CV 870.1130 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
(except non-oscillometric)
DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
FLE STERILIZER, STEAM
HO 880.2910 CLINICAL ELECTRONIC THERMOMETER (except tympanic or
pacifier)
CAF NEBUILIZER (DIRECT PATIENT INTERFACE)
AN 868.5925 POWERED EMERGENCY VENTILATOR
Hypodermic Needles and Syringes (except anti-stick and self-destruct):
MMIK CONTAINER, SHARPIES
MHC 1 PORT, INTRAOSSEOUS, IMPLANTED
FMF SYRINGE, PISTON
OR 888.3020 INTRAMEDULLARY FIXATION ROD
External Fixators (except devices with no external components):
OR 888.3030 SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
KTT APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION,
OR 888.3040 SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER
HTY PIN, FIXATION, SMOOTH
JDW PIN, FIXATION, THREADED
DE 872.3060 GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR
EMA 2 CEMENT, DENTAL
EMB ZINC OXIDE EUGENOL
ELW MATERIAL, IMPRESSION
EJH METAL BASE
HIS CONDOM
MEDICAL DEVICES FOR POSSIBLE INCLUSION
DURING OPERATIONAL PERIOD
Product Family Section No Device Name Tier
Gas Analyzer 868.1040 Powered Algesimeter 2
868.2775 Electrical peripheral nerve stimulator 2
868.1800 Rhinoanernometer 2
868.1890 Predictive pulmonary-function value calculator
868.2480 Cutaneous carbon dioxide (PcC02) monitor 2
868.2550 Pneurnotachomometer 2
870.2300 Cardiac monitor (including 2 cardlotachometer and rate alarm) 2
870.4380 Cardiopulmonary bypass pump- speed control 2
870.5050 Patient care suction apparatus 2
870.1750 External programmable pacemaker pulse generator 2
Dental implants 872.4880 Intraosseous fixation screw or wires 2
874.1120 Electronic noise generator for audlometric testing 2
874.4500 ENT microsurgical carbon dioxide laser 2
Endoscope (including
angloscopes,
laparscopes,
endoscopes) 876.1500 Endoscope and accessories 2
Hemodialysis 876.5600 Sorbent regenerate dialysate delivery system for hemodialysis 2
876.5830 Hemodialyzer with disposable insert (kill-type) 2
880.5860 Piston syringe (except anti-stick) 1
880.6920 Syrinqe needle introducer
882.5050 Blofeedback device 2
Echoencephalography 882.12401 Echoencephalograph 2
882.4305 Powered compound cranial drills, burrs, trephines and their accessories 2
882.4310 Powered simple cranial drills, burrs, trephines and accessories 2
Fetal Monitoring and accessories
Transcervical endoscope (amnioscope) 2
884.2675 Fetal scalp circular (spiral) electrode and applicator 2
Gynecological Surgery Equip. 884.1720 Gynecologic laparoscope and accessories 2
Ophthalm. Implants 886.3320 Eye sphere implant 2
Diagnostic Equipment 886.1120 Ophthalmic camera 1
886.1850 AC-powered slitlamp biomicroscope 1
Ophthalm. Implants 886.3340 Extraocular orbital implant 2
none Orthosis, spinal peclicle fixation
Diagnostic Equipment 890.1225 Chronaximeter 2
892.5700 Remote controlled radionuclide-applicator system 2
EC access to the U.S. market U.S. access to the EC market
Ministère de la Santé publique, de
I'Environnement et de I'Intégration sociale
Ministerie van Volksgezondheid, Leefmilieu
en Sociale Integratie
Ministère de I'emploi et de la solidarité
Ministère de 1'économie, des finances et de
Staat des Nederlanden
Sosiaali-ja terveysministeriö/social-och
Conformity assessment bodies located in
the EC shall be designated by the
Authorities identified in Appendix 3.
the U.S. shall be designated by the