AGREEMENT ON MUTUAL RECOGNITION 

BETWEEN 

THE EUROPEAN COMMUNITY 

AND THE UNITED STATES OF AMERICA 

CE/USA/en 1 
CE/USA/en 2 
TABLE OF CONTENTS 

Page 

1. Framework CE/USA/en 4 

2. Telecommunication Equipment CE/USA/Annex/en 1 

3. Electromagnetic Compatibility (EMC) CE/USA/Annex/en 17 

4. Electrical Safety CE/USA/Annex/en 32 

5. Recreational Craft CE/USA/ANNEX/en 42 

6. Pharmaceutical Good Manufacturing 

Practices (GMPs) CE/USA/Annex/en 51 

7. Medical Devices CE/USA/Annex/en 79-143 

CE/USA/en 3 
The EUROPEAN COMMUNITY, and the GOVERNMENT OF THE UNITED STATES OF 

AMERICA, hereinafter referred to as "the Parties", 

CONSIDERING the traditional links of friendship that exist between the United States of 

America (U.S.) and the European Community (EC); 

DESIRING to facilitate bilateral trade between them; 

RECOGNIZING that mutual recognition of conformity assessment activities is an 

important means of enhancing market access between the Parties; 

RECOGNIZING that an agreement providing for mutual recognition of conformity 

assessment activities is of particular interest to small and medium-sized businesses in the 

U.S. and the EC; 

RECOGNIZING that any such mutual recognition also requires confidence in the 

continued reliability of the other Party’s conformity assessments; 

RECOGNIZING the importance of maintaining each Party’s high levels of health, safety, 

environmental and consumer protection; 

RECOGNIZING that mutual recognition agreements can positively contribute in 

encouraging greater international harmonization of standards; 

CE/USA/en 4 
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. 

HAVE AGREED AS FOLLOWS: 

CE/USA/en 5 
ARTICLE 1 

DEFINITIONS 

1. The following terms and definitions shall apply to this Agreement only: 

 Designating Authority means a body with power to designate, monitor, suspend, 

remove suspension of, or withdraw conformity assessment bodies as specified 

under this Agreement. 

 Designation means the identification by a Designating Authority of a conformity 

assessment body to perform conformity assessment procedures under this 

Agreement. 

 Regulatory Authority means a government agency or entity that exercises a legal 

right to control the use or sale of products within a Party’s jurisdiction and may 

take enforcement action to ensure that products marketed within its jurisdiction 

comply with legal requirements. 

2. Other terms concerning conformity assessment used in this Agreement shall have 

the meaning given elsewhere in this Agreement or in the definitions contained in 

Guide 2 (1996 edition) of the International Organization for Standardization (ISO) and 

the International Electrotechnical Commission (IEC). In the event of an inconsistency 

between ISO/IEC Guide 2 and definitions in this Agreement, the definitions in this 

Agreement shall prevail. 

CE/USA/en 6 
ARTICLE 2 

PURPOSE OF THE AGREEMENT 

This Agreement specifies the conditions by which each Party will accept or recognize 

results of conformity assessment procedures, produced by the other Party's conformity 

assessment bodies or authorities, in assessing conformity to the importing Party's 

requirements, as specified on a sector-specific basis in the Sectoral Annexes, and to 

provide for other related cooperative activities. The objective of such mutual 

recognition is to provide effective market access throughout the territories of the 

Parties with regard to conformity assessment for all products covered under this 

Agreement. If any obstacles to such access arise, consultations will promptly be held. 

In the absence of a satisfactory outcome of such consultations, the Party alleging its 

market access has been denied, may, within 90 days of such consultation, invoke its 

right to terminate the Agreement in accordance with Article 21. 

ARTICLE 3 

GENERAL OBLIGATIONS 

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. 

CE/USA/en 7 
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 

applicable legislative, regulatory and administrative provisions of that Party, equivalent 

to the assurance offered by the receiving Party’s own procedures. 

ARTICLE 4 

GENERAL COVERAGE OF THE AGREEMENT 

1. This Agreement applies to conformity assessment procedures for products and/or 

processes and to other related cooperative activities as described in this Agreement. 

2. Sectoral Annexes may include: 

(a) a description of the relevant legislative, regulatory and administrative provisions 

pertaining to the conformity assessment procedures and technical regulations; 

CE/USA/en 8 
(b) a statement on the product scope and coverage; 

(c) a list of Designating Authorities; 

(d) a list of agreed conformity assessment bodies or authorities or a source from 

which to obtain a list of such bodies or authorities and a statement of the scope 

of the conformity assessment procedures for which each has been agreed; 

(e) the procedures and criteria for designating the conformity assessment bodies; 

(f) a description of the mutual recognition obligations; 

(g) a sectoral transition arrangement; 

(h) the identity of a sectoral contact point in each Party’s territory; and 

(i) a statement regarding the establishment of a Joint Sectoral Committee. 

3. This Agreement shall not be construed to entail mutual acceptance of standards or 

technical regulations of the Parties and, unless otherwise specified in a Sectoral Annex, 

shall not entail the mutual recognition of the equivalence of standards or technical 

regulations. 

CE/USA/en 9 
ARTICLE 5 

TRANSITIONAL ARRANGEMENTS 

The Parties agree to implement the transitional commitments on confidence building 

as specified in the Sectoral Annexes. 

1. The Parties agree that each sectoral transitional arrangement shall specify a time 

period for completion. 

2. The Parties may amend any transitional arrangement by mutual agreement. 

3. Passage from the transitional phase to the operational phase shall proceed as 

specified in each Sectoral Annex, unless either Party documents that the conditions 

provided in such Sectoral Annex for a successful transition are not met. 

ARTICLE 6 

DESIGNATING AUTHORITIES 

The Parties shall ensure that the Designating Authorities specified in the Sectoral 

Annexes have the power and competence in their respective territories to carry out 

decisions under this Agreement to designate, monitor, suspend, remove suspension of, 

or withdraw conformity assessment bodies. 

CE/USA/en 10 
ARTICLE 7 

DESIGNATION AND LISTING PROCEDURES 

The following procedures shall apply with regard to the designation of conformity 

assessment bodies and the inclusion of such bodies in the list of conformity assessment 

bodies in a Sectoral Annex: 

(a) The Designating Authority identified in a Sectoral Annex shall designate 

conformity assessment bodies in accordance with the procedures and criteria 

set forth in that Sectoral Annex; 

(b) A Party proposing to add a conformity assessment body to the list of such bodies 

in a Sectoral Annex shall forward its proposal of one or more designated 

conformity assessment bodies in writing to the other Party with a view to a 

decision by the Joint Committee; 

(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 

CE/USA/en 11 
(d) In the event that the other Party contests on the basis of documented evidence 

the technical competence or compliance of a proposed conformity assessment 

body, or indicates in writing that it requires an additional 30 days to more fully 

verify such evidence, such conformity assessment body shall not be included on 

the list of conformity assessment bodies in the applicable Sectoral Annex. In this 

instance, the Joint Committee may decide that the body concerned be verified. 

After the completion of such verification, the proposal to list the conformity 

assessment body in the Sectoral Annex may be resubmitted to the other Party. 

ARTICLE 8 

SUSPENSION OF LISTED CONFORMITY ASSESSMENT BODIES 

The following procedures shall apply with regard to the suspension of a conformity 

assessment body listed in a Sectoral Annex: 

(a) A Party shall notify the other Party of its contestation of the technical 

competence or compliance of a conformity assessment body listed in a Sectoral 

Annex and the contesting Party’s intent to suspend such conformity assessment 

body. Such contestation shall be exercised when justified in an objective and 

reasoned manner in writing to the other Party; 

CE/USA/en 12 
(b) The conformity assessment body shall be given prompt notice by the other Party 

and an opportunity to present information in order to refute the contestation or 

to correct the deficiencies which form the basis of the contestation; 

(c) Any such contestation shall be discussed between the Parties in the relevant Joint 

Sectoral Committee. If there is no Joint Sectoral Committee, the contesting Party 

shall refer the matter directly to the Joint Committee. If agreement to suspend is 

reached by the Joint Sectoral Committee or, if there is no Joint Sectoral 

Committee, by the Joint Committee, the conformity assessment body shall be 

suspended; 

(d) Where the Joint Sectoral Committee or Joint Committee decides that verification 

of technical competence or compliance is required, it shall normally be carried 

out in a timely manner by the Party in whose territory the body in question is 

located, but may be carried out jointly by the Parties in justified cases; 

(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; 

CE/USA/en 13 
(f) Upon the suspension of a conformity assessment body listed in a Sectoral Annex, 

a Party is no longer obligated to accept or recognize the results of conformity 

assessment procedures performed by that conformity assessment body 

subsequent to suspension. A Party shall continue to accept the results of 

conformity assessment procedures performed by that conformity assessment 

body prior to suspension, unless a Regulatory Authority of the Party decides 

otherwise based on health, safety or environmental considerations or failure to 

satisfy other requirements within the scope of the applicable Sectoral Annex; and 

(g) The suspension shall remain in effect until agreement has been reached by the 

Parties upon the future status of that body. 

ARTICLE 9 

WITHDRAWAL OF LISTED CONFORMITY ASSESSMENT BODIES 

The following procedures shall apply with regard to the withdrawal from a Sectoral 

Annex of a conformity assessment body: 

(a) A Party proposing to withdraw a conformity assessment body listed in a Sectoral 

Annex shall forward its proposal in writing to the other Party; 

CE/USA/en 14 
(b) Such conformity assessment body shall be promptly notified by the other Party 

and shall be provided a period of at least 30 days from receipt to provide 

information in order to refute or to correct the deficiencies which form the basis 

of the proposed withdrawal; 

(c) Within 60 days following receipt of the proposal, the other Party shall indicate its 

position regarding either its confirmation or its opposition. Upon confirmation, the 

withdrawal from the list in the Sectoral Annex of the conformity assessment body 

shall take effect; 

(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. 

CE/USA/en 15 
ARTICLE 10 

MONITORING OF CONFORMITY ASSESSMENT BODIES 

The following shall apply with regard to the monitoring of conformity assessment bodies 

listed in a Sectoral Annex: 

(a) Designating Authorities shall assure that their conformity assessment bodies listed 

in a Sectoral Annex are capable and remain capable of properly assessing 

conformity of products or processes, as applicable, and as covered in the 

applicable Sectoral Annex. In this regard, Designating Authorities shall maintain, 

or cause to maintain, ongoing surveillance over their conformity assessment 

bodies by means of regular audit or assessment; 

(b) The Parties undertake to compare methods used to verify that the conformity 

assessment bodies listed in the Sectoral Annexes comply with the relevant 

requirements of the Sectoral Annexes. Existing systems for the evaluation of 

conformity assessment bodies may be used as part of such comparison 

procedures; 

(c) Designating Authorities shall consult as necessary with their counterparts, to 

ensure the maintenance of confidence in conformity assessment procedures. 

With the consent of both Parties, this consultation may include joint participation 

in audits/inspections related to conformity assessment activities or other 

assessments of conformity assessment bodies listed in a Sectoral Annex; and 

CE/USA/en 16 
(d) Designating Authorities shall consult, as necessary, with the relevant Regulatory 

Authorities of the other Party to ensure that all technical requirements are 

identified and are satisfactorily addressed. 

ARTICLE 11 

CONFORMITY ASSESSMENT BODIES 

Each Party recognizes that the conformity assessment bodies listed in the Sectoral 

Annexes 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. 

ARTICLE 12 

EXCHANGE OF INFORMATION 

1. The Parties shall exchange information concerning the implementation of the 

legislative, regulatory, and administrative provisions identified in the Sectoral Annexes. 

CE/USA/en 17 
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. 

ARTICLE 13 

SECTORAL CONTACT POINTS 

Each Party shall appoint and confirm in writing contact points to be responsible for 

activities under each Sectoral Annex. 

CE/USA/en 18 
ARTICLE 14 

JOINT COMMITTEE OF THE PARTIES 

1. The Parties hereby establish a Joint Committee consisting of representatives of 

each Party. The Joint Committee shall be responsible for the effective functioning of 

the Agreement. 

2. The Joint Committee may establish Joint Sectoral Committees comprised of 

appropriate Regulatory Authorities and others deemed necessary. 

3. Each Party shall have one vote in the Joint Committee. The Joint Committee shall 

make its decisions by unanimous consent. The Joint Committee shall determine its own 

rules and procedures. 

4. The Joint Committee may consider any matter relating to the effective functioning 

of this Agreement. In particular it shall be responsible for: 

(a) listing, suspension, withdrawal and verification of conformity assessment bodies in 

accordance with this Agreement; 

(b) amending transitional arrangements in Sectoral Annexes; 

CE/USA/en 19 
(c) resolving any questions relating to the application of this Agreement and its 

Sectoral Annexes not otherwise resolved in the respective Joint Sectoral 

Committees; 

(d) providing a forum for discussion of issues that may arise concerning the 

implementation of this Agreement; 

(e) considering ways to enhance the operation of this Agreement; 

(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. 

CE/USA/en 20 
ARTICLE 15 

PRESERVATION OF REGULATORY AUTHORITY 

1. Nothing in this Agreement shall be construed to limit the authority of a Party to 

determine, through its legislative, regulatory and administrative measures, the level of 

protection it considers appropriate for safety; for protection of human, animal, or plant 

life or health; for the environment; for consumers; and otherwise with regard to risks 

within the scope of the applicable Sectoral Annex. 

2. Nothing in this Agreement shall be construed to limit the authority of a Regulatory 

Authority to take all appropriate and immediate measures whenever it ascertains that 

a product may: (a) compromise the health or safety of persons in its territory; (b) not 

meet the legislative, regulatory, or administrative provisions within the scope of the 

applicable Sectoral Annex; or (c) otherwise fail to satisfy a requirement within the 

scope of the applicable Sectoral Annex. Such measures may include withdrawing the 

products from the market, prohibiting their placement on the market, restricting their 

free movement, initiating a product recall, and preventing the recurrence of such 

problems, including through a prohibition on imports. If the Regulatory Authority takes 

such action, it shall inform its counterpart authority and the other Party within fifteen 

days of taking such action, providing its reasons. 

CE/USA/en 21 
ARTICLE 16 

SUSPENSION OF RECOGNITION OBLIGATIONS 

Either Party may suspend its obligations under a particular Sectoral Annex, in whole or 

in part, if: 

(a) a Party suffers a loss of market access for the Party’s products within the scope of 

the Sectoral Annex as a result of the failure of the other Party to fulfil its obligations 

under the Agreement; 

(b) the adoption of new or additional conformity assessment requirements as 

referenced in Article 14(5) results in a loss of market access for the Party’s 

products within the scope of the Sectoral Annex because conformity assessment 

bodies designated by the Party in order to meet such requirements have not 

been recognized by the Party implementing the requirements; or 

(c) the other Party fails to maintain legal and regulatory authorities capable of 

implementing the provisions of this Agreement. 

CE/USA/en 22 
ARTICLE 17 

CONFIDENTIALITY 

1. Each Party agrees to maintain, to the extent required under its laws, the 

confidentiality of information exchanged under this Agreement. 

2. In particular, neither Party shall disclose to the public, nor permit a conformity 

assessment body to disclose to the public, information exchanged under this 

Agreement that constitutes trade secrets, confidential commercial or financial 

information, or information that relates to an ongoing investigation. 

3. A Party or a conformity assessment body may, upon exchanging information with 

the other Party or with a conformity assessment body of the other Party, designate the 

portions of the information that it considers to be exempt from disclosure. 

4. Each Party shall take all precautions reasonably necessary to protect information 

exchanged under this Agreement from unauthorized disclosure. 

CE/USA/en 23 
ARTICLE 18 

FEES 

Each Party shall endeavor to ensure that fees imposed for services under this 

Agreement shall be commensurate with the services provided. Each Party shall ensure 

that, for the sectors and conformity assessment procedures covered under this 

Agreement, it shall charge no fees with respect to conformity assessment services 

provided by the other Party. 

ARTICLE 19 

AGREEMENTS WITH OTHER COUNTRIES 

Except where there is written agreement between the Parties, obligations contained in 

mutual recognition agreements concluded by either Party with a party not a signatory 

to this Agreement (a third party) shall have no force and effect with regard to the 

other Party in terms of acceptance of the results of conformity assessment procedures 

in the third party. 

CE/USA/en 24 
ARTICLE 20 

TERRITORIAL APPLICATION 

This Agreement shall apply, on the one hand, to the territories in which the Treaty 

establishing the European Community is applied, and under the conditions laid down 

in that Treaty and, on the other hand, to the territory of the United States. 

ARTICLE 21 

ENTRY INTO FORCE, AMENDMENT AND TERMINATION 

1. This Agreement including its Sectoral Annexes on 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 

entry into force of this Agreement. 

2. This Agreement including any Sectoral Annex may, through the Joint Committee, 

be amended in writing by the Parties. The Parties may add a Sectoral Annex upon the 

exchange of letters. Such Annex shall enter into force 30 days following the date on 

which the Parties have exchanged letters confirming the completion of their 

respective procedures for the entry into force of the Sectoral Annex. 

CE/USA/en 25 
3. Either Party may terminate this Agreement in its entirety or any individual Sectoral 

Annex thereof by giving the other Party six months notice in writing. In the case of 

termination of one or more Sectoral Annexes, the Parties will seek to achieve by 

consensus to amend this Agreement, with a view to preserving the remaining Sectoral 

Annexes, in accordance with the procedures in this Article. Failing such consensus, the 

Agreement shall terminate at the end of six months 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 

within the scope of the applicable Sectoral Annex. 

ARTICLE 22 

FINAL PROVISIONS 

1. The Sectoral Annexes referred to in Article 21(1), as well as any New Sectoral 

Annexes added pursuant to Article 21(2), shall form an integral part of this Agreement. 

2. For a given product or sector, the provisions contained in the relevant Sectoral 

Annexes shall apply in the first place, and the provisions of this text in addition to those 

provisions. In the case of any inconsistency between the provisions of a Sectoral 

Annex and this text, the Sectoral Annex shall prevail, to the extent of that 

inconsistency. 

CE/USA/en 26 
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. 

CE/USA/en 27 

U.S. - EC MRA Telecommunication Equipment Annex 

SECTORAL ANNEX 

FOR 

TELECOMMUNICATION EQUIPMENT 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of 

Conformity Assessment between the United States and the European Community. 

CE/USA/Annex/en 1 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION I 

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS 

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.); 

Commission Decisions (CTRs) established under 

Directive 98/13/EC; 

The EC Member States’ 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 

connections; 

For electrical safety, see Electrical Safety 

Sectoral Annex to the Agreement; 

For electromagnetic compatibility aspects, see 

Electromagnetic Compatibility (EMC) Sectoral 

Annex to the Agreement. 

Communications Act of 1934, as amended by 

the Telecommunication Act of 1996, (Title 47 of 

the United States Code), 

the U.S. regulatory and administrative provisions 

in respect of telecommunication equipment, 

including 47 CFR Part 68, and FCC 

interpretation thereof; 

(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; 

For electrical safety, see Electrical Safety 

Sectoral Annex to the Agreement; 

For electromagnetic compatibility aspects, see 

Electromagnetic Compatibility (EMC) Sectoral 

Annex to the Agreement. 

CE/USA/Annex/en 2 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION II 

SCOPE AND COVERAGE 

1. This Sectoral Annex shall apply to equipment, interfaces, and services subject to 

Section I. In general terms the provisions of this Sectoral Annex shall apply to the 

following types of 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 

either Party. 

2. The following is a non-exclusive list of the equipment, interfaces, and services 

included within the scope of this Sectoral Annex: 

CE/USA/Annex/en 3 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION II (continued) 

SCOPE AND COVERAGE 

EC U.S. 

The following equipment categories are 

included: 

ISDN Basic Rate Access 

ISDN Primary Rate Access 

ISDN Telephony 

X21/V.24/V.35 Access 

X25 Access 

PSTN Non-Voice 

PSTN Voice Band (Analog) 

ONP Leased Line Terminal types: 

-64 kbits/sec 

-2048 kbits/s unstructured 

-2048 kbits/s structured 

-34 Mbits/s access 

-140 Mbits/s access 

-2 wire analogue 

-4 wire analogue 

Radio transmitters subject to an equipment 

authorization requirement, including: 

-Short range devices, including low power 

devices such as cordless 

telephones/microphones; 

-Land mobile, including: 

- Private Mobile Radio (PMR/PAMR) 

- Mobile telecom 

- Paging systems 

- Terrestrial fixed 

- Satellite mobile 

- Satellite fixed 

- Broadcast 

- Radio determination 

Equipment categories covered under 47 CFR 

Part 68, including: 

ISDN Basic Access 

ISDN Primary Rate Access 

Digital Service Access: 

2.4 kbps 

3.2 kbps (2.4 kbps with Secondary Channel) 

4.8 kbps 

6.4 kbps (4.8 kbps with SC) 

9.6 kbps 

12.8 kbps (9.6 kbps with SC) 

19.2 kbps 

25.0 kbps (19.2 kbps with SC) 

56.0 kbps 

64.0 kbps (uses 72 kbps channel) 

72.0 kbps (56.0 kbps with SC) 

1.544 Mbps 

2 wires analog tie trunks/ops 

4 wire analog tie trunks/ops 

PSTN Voice Band (Analog) Access 

Private Line (Analog) Access 

Radio transmitters subject to an equipment 

authorization requirement, including: 

Commercial Mobile Radio (Part 20) 

Domestic Public Fixed 

Domestic Mobile (Part 22) 

Personal Communication Service(Part 24) 

Satellite Communications (Part 25) 

Broadcast 

Auxiliary Broadcast 

Cable Television Radio (Part 78) 

Maritime (Part 80) 

GMDSS (Part 80W) 

Private Land Mobile 

Private-Fixed Microwave (Part 94) 

Personal Radio Services (Part 95) 

IVDS (Part 95 F) 

Amateur Radio 

Radio Frequency Devices (Part 15) 

Fixed Microwave Services (Part 101) 

Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral 

Annex. 

CE/USA/Annex/en 4 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION III 

CONFORMITY ASSESSMENT PROCEDURES 

FOR TELECOMMUNICATION EQUIPMENT 

1. Description of Mutual Recognition Obligations 

In accordance with the provisions of the Agreement, the results of the conformity 

assessment procedures produced by a Party’s conformity assessment bodies listed in 

Section V shall be recognized by the Regulatory Authorities of the other Party without 

any further conformity assessment of the products, pursuant to Section I. 

2. Conformity Assessment Procedures 

Taking into account the legislative, regulatory, and administrative provisions as 

identified in Section I, each Party recognizes that the conformity assessment bodies of 

the other Party, listed in Section V, are authorized to perform the following procedures 

with regard to the importing Party’s technical requirements for telecommunication 

terminal equipment, satellite terminal equipment, radio transmitters or information 

technology equipment: 

(a) testing and issuing of test reports; 

(b) issuing certificates of conformity to the requirements of the laws and regulations 

applicable in the territories of the Parties for products covered under this Sectoral 

Annex; and 

(c) performing quality assurance certification pursuant to Directive 98/13/EC. 

CE/USA/Annex/en 5 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION IV 

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE 

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

EC 

Belgium

Institut belge des services postaux et des

télécommunications 

Belgisch instituut voor postdiensten en

telecommunicatie 

U.S. 

National Institute of Standards and Technology

(NIST) 

Federal Communications Commission (FCC) 

Denmark: 

Telestyrelsen 

Germany:

Bundesministerium für Wirtschaft 

Greece: 

=ΞΩ]ΨΚΜΓΩ 5Μ∴ΙφΩΨφΥ ΡΙΘ .ΞΘΡΩΘΥαΥΘφΥ

Ministry of Transport and Communications 

Spain:

Ministerio de Fomento 

France: 

Ministère de l'économie, des finances et de 

l'industrie 

Ireland: 

Department of Transport, Energy and

Communications 

Italy:

Ispettorato Generale TLC 

Luxembourg:

Administration des Postes et 

Télécommunications 

Netherlands: 

De Minister van Verkeer en Waterstaat 

Austria: 

Bundesministerium für Wissenschaft und 

Verkehr 

Portugal:

Instituto das Communicações de Portugal 

Finland: 

Liikenneministeriö/Trafikministeriet

Telehallintokeskus/Teleförvaltningscentralen 

Sweden: 

Under the authority of the Government of 

Sweden: Styrelsen för ackreditering och teknisk

kontroll (SWEDAC) 

UK: 

Department of Trade and Industry 

CE/USA/Annex/en 6 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION V 

CONFORMITY ASSESSMENT BODIES 

EC access to US market U.S. access to EC market 

Conformity assessment bodies located 

in the EC shall be designated by the 

Authorities identified in Section IV 

following the procedures set out in 

Section VI of this Annex. 

(to be provided by the EC) 

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. 

(to be provided by the U.S.) 

CE/USA/Annex/en 7 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION VI 

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING 

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

EC access to U.S. market: U.S. access to EC 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. 

Procedures for designating, listing, 

suspending, withdrawing, and 

monitoring a conformity assessment 

body listed in Section V shall be 

undertaken pursuant to Articles 7, 8, 9 

and 10 of the Agreement. 

U.S. Authorities identified in Section IV 

shall designate conformity assessment 

bodies located in the U.S. in 

accordance with the EC legislative, 

regulatory, and administrative provisions 

identified in Section I that govern 

designation of conformity assessment 

bodies, based on compliance with the 

appropriate EN-45000 Series Standards 

or the comparable ISO/IEC Guides (e.g. 

Guide 22, 25, 28, 58, 61, 62, 65, etc.). 

Procedures for designating, listing, 

suspending, withdrawing, and 

monitoring a conformity assessment 

body listed in Section V shall be 

undertaken pursuant to Articles 7, 8, 9 

and 10 of the Agreement. 

CE/USA/Annex/en 8 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION VII 

ADDITIONAL PROVISIONS 

1. SUB-CONTRACTING 

1.1. Any sub-contracting by conformity assessment bodies shall be in accordance 

with the sub-contracting requirements of the other Party. Notwithstanding the 

use of sub-contracting, the final results of conformity assessment remain the full 

responsibility of the listed conformity assessment body. In the EC, these 

requirements are described in Council Decision 93/465/EEC. 

1.2. The conformity assessment bodies shall record and retain details of their 

investigation of the competence and compliance of their subcontractors and 

maintain a register of all sub-contracting. These details will be available to the 

other Party on request. 

CE/USA/Annex/en 9 
U.S. - EC MRA Telecommunication Equipment Annex 

2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND INTERNAL MOVEMENT 

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. 

CE/USA/Annex/en 10 
U.S. - EC MRA Telecommunication Equipment Annex 

3. JOINT SECTORAL COMMITTEE 

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 

procedure. 

3.2. The JSC consists of representatives of the U.S. and the EC for telecommunications 

and EMC. JSC representatives may each invite manufacturers and other 

entities as deemed necessary. The representatives for the U.S. shall have one 

vote in the JSC. The representatives of the EC shall have one vote in the JSC. 

Decisions of the JSC shall be made by unanimous consent. In the event of 

disagreement either the U.S. or EC representative may raise the matter in the 

Joint Committee. 

3.3. The JSC may address any matter related to the effective functioning of this 

Sectoral Annex, including: 

(a) providing a forum for discussion of issues and resolving problems that may 

arise concerning the implementation of this Sectoral Annex; 

(b) developing a mechanism for ensuring consistency of interpretations of 

legislation, regulations, standards, and conformity assessment 

procedures; 

CE/USA/Annex/en 11 
U.S. - EC MRA Telecommunication Equipment Annex 

(c) advising the Parties on matters relating to this Sectoral Annex; and 

(d) providing guidance and, if necessary, developing guidelines during the 

transitional period to facilitate the successful completion of the 

transitional period. 

4. CONTACT POINT 

Each Party shall establish a contact point to provide answers to all reasonable 

inquiries from the other Party regarding procedures, regulations, and complaints 

under this Sectoral Annex. 

5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX 

In the event that there are changes to the legislative, regulatory, and 

administrative provisions referenced in Section I or the introduction of new 

legislative, regulatory, and administrative provisions affecting either Party’s 

conformity assessment procedures under the Agreement, such changes shall 

take effect for the purpose of this Sectoral Annex at the same time they take 

effect domestically within the territory of each Party. The Parties shall update 

this Sectoral Annex to reflect the changes. 

CE/USA/Annex/en 12 
U.S. - EC MRA Telecommunication Equipment Annex 

SECTION VIII 

TRANSITIONAL ARRANGEMENT 

1. There shall be a transitional period of 24 months. 

2. The purpose of this transitional arrangement is to provide a means whereby the 

Parties to the Agreement can build confidence in and an understanding of 

each other's system for designating and listing conformity assessment bodies 

and in the ability of these bodies to test and certify products. Successful 

completion of the transitional arrangement should result in the determination 

that conformity assessment bodies listed in Section V comply with the 

applicable criteria and are competent to conduct conformity assessment 

activities on behalf of the other Party. Upon successful completion of the 

transition period, the results of conformity assessment procedures performed by 

the exporting Party’s conformity assessment bodies listed in Section V of the 

exporting country shall be accepted by the importing Party. 

3. This transitional period shall be used by the Parties: 

(a) to consider new legislative changes needed to support the objectives of 

the Agreement; 

(b) to initiate regulatory changes needed to support the objectives of the 

Agreement; 

CE/USA/Annex/en 13 
U.S. - EC MRA Telecommunication Equipment Annex 

(c) to exchange information on and develop better understanding of their 

respective regulatory requirements; 

(d) to develop mutually agreed mechanisms for exchanging information on 

changes in technical requirements or methods of designating conformity 

assessment bodies; and 

(e) to monitor and evaluate the performance of the listed conformity 

assessment bodies during the transitional period. 

4. Parties may designate, list, suspend and withdraw conformity assessment bodies 

during the transitional period according to the procedures in Section VI of this 

Sectoral Annex. 

5. During the transitional period each Party shall accept and evaluate test reports 

and related documents issued by designated conformity assessment bodies of 

the other Party. To this end, the Parties shall ensure that: 

(a) on receipt of test reports, related documents and a first evaluation of 

conformity, the dossiers are promptly examined for completeness; 

(b) the applicant is informed in a precise and complete manner of any 

deficiency; 

CE/USA/Annex/en 14 
U.S. - EC MRA Telecommunication Equipment Annex 

(c) any request for additional information is limited to omissions, inconsistencies 

or variances from the technical regulations or standards; and 

(d) procedures for assessing the conformity for equipment, modified 

subsequent to a determination of compliance, are limited to procedures 

necessary to determine continued conformance. 

6. Each Party ensures that issuance of approvals, certificates, or advice to the 

applicant shall be given no later than six weeks from receipt of the test report 

and evaluation from a designated conformity assessment body in the territory of 

the other Party. 

7. Any proposal made during or at the end of the transitional period to limit the 

scope of recognition of any designated conformity assessment body or to 

exclude it from the list of bodies designated under this Sectoral Annex shall be 

based on objective criteria and documented. Any such body may apply for 

reconsideration once the necessary corrective action has been taken. To the 

extent possible, the Parties shall implement such action prior to the expiry of the 

transitional period. 

8. The Parties may jointly sponsor two seminars, one in the U.S. and one in the 

European Community, concerning the relevant technical and product 

approval requirements during the first year after this Sectoral Annex enters into 

force. 

9. Passage from the transitional phase into the operational phase in this Sectoral 

Annex shall take place provided that a representative number of conformity 

assessment bodies have been accepted for recognition under the Electrical 

Safety Annex. 

CE/USA/Annex/en 15 
U.S. - EC MRA Telecommunication Equipment Annex 

APPENDIX 1 

LISTS OF ACRONYMS AND GLOSSARY 

ACTE Approvals Committee for Terminal Equipment 

ADLNB Association of Designated Laboratories and Notified Bodies 

CAB Conformity Assessment Body 

CFR U.S. Code of Federal Regulations, Title 47 CFR 

CTR Common Technical Regulation 

EC European Community 

EEC European Economic Community 

EN Norme Européenne (European Standard) 

EU European Union 

FCC Federal Communications Commission 

IEC International Electrotechnical Commission 

ISDN Integrated Services Digital Network 

ISO International Standards Organization 

ITU International Telecommunications Union 

MRA Mutual Recognition Agreement 

MS Member States (of the European Union) 

NB Notified Bodies 

NIST National Institute of Standards and Technology 

OJ Official Journal (of the European Union) 

ONP Open Network Provision 

PSTN Public Switched Telephone Network 

STG Sectoral Technical Group for Telecommunications 

TBR Technical Basis for Regulation 

X21 ITU-T Recommendation X21 

X25 ITU-T Recommendation X25 

CE/USA/Annex/en 16 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTORAL ANNEX 

FOR 

ELECTROMAGNETIC COMPATIBILITY 

(EMC) 

CE/USA/Annex/en 17 
U.S. - EC MRA Electromagnetic Compatibility Annex 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of 

Conformity Assessment between the United States and the European Community. 

CE/USA/Annex/en 18 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION I 

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS 

EC U.S. 

Council Directive 89/336/EEC, as 

amended by Council 

Directive 92/31/EEC, and 

Directive 98/13/EC of the European 

Parliament and of the Council and 

interpretation thereof. 

For electrical safety aspects see 

Electrical Safety Sectoral Annex to the 

Agreement. 

For telecommunication equipment 

and radio transmitters, see also 

Telecommunication Equipment 

Sectoral Annex to the Agreement. 

Communications Act of 1934, as 

amended by the Telecommunication 

Act of 1996, (Title 47 of the United States 

Code), 

the U.S. regulatory and administrative 

provisions in respect of equipment 

subject to electromagnetic 

requirements including: 

 47 CFR Part 15 

 47 CFR Part 18, 

and FCC interpretation thereof. 

For electrical safety aspects see 

Electrical Safety Sectoral Annex to the 

Agreement. 

For telecommunication equipment and 

radio transmitters, see also 

Telecommunication Equipment Sectoral 

Annex to the Agreement. 

CE/USA/Annex/en 19 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION II 

SCOPE AND COVERAGE 

US access to the EC market: EC access to the US market: 

Any product falling under the scope 

of Council Directive 89/336/EEC. 

Any products falling under the scope 

of 47 CFR Part 15 and 18. 

CE/USA/Annex/en 20 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION III 

CONFORMITY ASSESSMENT PROCEDURES 

FOR EQUIPMENT IDENTIFIED IN SECTION II 

1. Description of Mutual Recognition Obligations 

In accordance with the provisions of the Agreement, the results of the conformity 

assessment procedures produced by a Party's conformity assessment bodies listed 

in Section V, shall be recognized by the Regulatory Authorities of the other Party 

without any further conformity assessment of the products, pursuant to Section I. 

2. Conformity Assessment Procedures 

Taking into account the legislative, regulatory, and administrative provisions as 

identified in Section I, each Party recognizes that the conformity assessment bodies 

of the other Party, listed in Section V, are authorized to perform the following 

procedures with regard to the importing Party's technical requirements for 

equipment identified in Section II: 

(a) testing and issuing of test reports; 

(b) issuing certificates of conformity to the requirements of the laws and regulations 

applicable in the territories of the Parties for products covered under this 

Sectoral Annex. 

CE/USA/Annex/en 21 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION IV 

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE 

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

EC U.S. 

 Belgium 

Ministère des Affaires Economiques 

Ministerie van Economische Zaken 

 Denmark 

for telecommunication equipment: 

Telestyrelsen 

for other equipment: 

Danmarks Elektriske Materielkontrol 

(DEMKO) 

 Germany 

Bundesministerium für Wirtschaft 

 Greece 

=ΞΩ]ΨΚΜΓΩ 5Μ∴ΙφΩΨφΥ ΡΙΘ .ΞΘΡΩΘΥαΥΘφΥ 

Ministry of Transport and 

Communications 

 Spain 

for telecommunication equipment: 

Ministerio de Fomento 

for other equipment: 

Ministerio de Industria y Energía 

 France 

Ministère de l'économie, des finances et de l'industrie 

 Ireland 

Department of Transport, Energy and 

Communications 

 Italy 

Ministero dell'Industria, del Commercio e dell' 

Artigianato 

 Luxembourg 

Ministère des Transports 

 Netherlands 

De Minister van Verkeer en Waterstaat 

 Austria 

for telecommunication equipment: 

Bundesministerium für Wissenschaft und Verkehr 

for other equipment: 

Bundesministerium für wirtschaftliche 

Angelegenheiten 

 Portugal 

Instituto Português das Comunicaçôes de Portugal 

 Finland 

for telecommunication equipment: 

Liikenneministeriö/Trafikministeriet 

for other equipment: 

Kauppa- ja teollisuusministeriö/Handels-och 

industriministeriet 

 Sweden 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontroll (SWEDAC) 

 UK 

National Institute for Standards and Technology 

(NIST) 

Federal Communications Commission 

(FCC) 

Federal Aviation Administration 

(FAA) 

CE/USA/Annex/en 22 
U.S. - EC MRA Electromagnetic Compatibility Annex 

Department of Trade and Industry 

CE/USA/Annex/en 23 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION V 

CONFORMITY ASSESSMENT BODIES 

EC access to the U.S. market: U.S. access to the EC market: 

Conformity assessment bodies 

located in the EC shall be 

designated by the Authorities 

identified in Section IV following the 

procedures set out in Section VI of 

this Annex. 

(to be provided by the EC) 

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. 

(to be provided by the U.S.) 

CE/USA/Annex/en 24 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION VI 

DESIGNATING, LISTING, SUSPENDING, WITHDRAWING 

AND MONITORING CONFORMITY ASSESSMENT BODIES 

LISTED IN SECTION V 

EC Access to U.S. Market: U.S. Access to EC 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 upon 

compliance with the appropriate 

ISO/IEC Guides (e.g. Guide 22, 25, 28, 

58, 61, 62, 65, etc.) or the comparable 

EN-45000 Series Standards. 

Procedures for designating, listing, 

suspending, withdrawing, and 

monitoring a conformity assessment 

body listed in Section V shall be 

undertaken pursuant to Articles 7, 8, 9, 

and 10 of the Agreement. 

U.S. Authorities identified in Section IV 

shall designate conformity assessment 

bodies located in the U.S. in 

accordance with the EC legislative, 

regulatory, and administrative 

provisions identified in Section I that 

govern designation of conformity 

assessment bodies, based on 

compliance with the appropriate 

EN-45000 Series Standards or the 

comparable ISO/IEC Guides (e.g. 

Guide 22, 25, 28, 58, 61, 62, 65, etc.). 

Procedures for designating, listing, 

suspending, withdrawing, and 

monitoring a conformity assessment 

body listed in Section V shall be 

undertaken pursuant to Articles 7, 8, 9, 

and 10 of the Agreement. 

CE/USA/Annex/en 25 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION VII 

ADDITIONAL PROVISIONS 

1. SUB-CONTRACTING 

1.1. Any sub-contracting by conformity assessment bodies shall be in accordance 

with the sub-contracting requirements of the other Party. Notwithstanding the 

use of sub-contracting, the final results of conformity assessment remain the full 

responsibility of the listed conformity assessment body. In the EC, these 

requirements are described in Council Decision 93/465/EEC. 

1.2. The conformity assessment bodies shall record and retain details of its 

investigation of the competence and compliance of its sub-contractors and 

maintain a register of all sub-contracting. These details will be available to the 

other Party on request. 

2. POST-MARKET SURVEILLANCE, BORDER MEASURES AND INTERNAL MOVEMENT 

2.1. For the purpose of post-market surveillance, the Parties may maintain any existing 

labeling and numbering requirements. The assignment of the numbers may take 

place in the territory of the exporting Party. The numbers will be allocated by the 

importing Party. Numbering and labeling systems shall not introduce additional 

requirements within the meaning of this Sectoral Annex. 

CE/USA/Annex/en 26 
U.S. - EC MRA Electromagnetic Compatibility Annex 

2.2. Nothing in this Sectoral Annex shall prevent the Parties from removing products 

from the market that do not in fact conform to the requirements for approval. 

2.3. The Parties agree that border inspections and checks of products which have 

been certified, labeled or marked as conforming with the importing Party's 

requirements specified in Section I shall be completed as expeditiously as 

possible. With regard to any inspections related to internal movement within their 

respective territories, the Parties agree that these shall be completed in no less a 

favorable manner than for like-domestic goods. 

3. JOINT SECTORAL COMMITTEE 

3.1. A combined Joint Sectoral Committee for this Sectoral Annex and the 

Telecommunications Equipment Sectoral Annex is hereby established (the JSC). 

The JSC shall operate during the transitional period and after completion of the 

transitional arrangement. The JSC shall meet as appropriate to discuss technical, 

conformity assessment and technology issues relating to this Sectoral Annex and 

the Telecommunications Equipment Sectoral Annex. The JSC shall determine its 

own rules of procedure. 

CE/USA/Annex/en 27 
U.S. - EC MRA Electromagnetic Compatibility Annex 

3.2. The JSC consists of representatives of the U.S. and the EC for telecommunications 

and EMC. JSC representatives may each invite manufacturers and other entities 

as deemed necessary. The representatives for the U.S. shall have one vote in the 

JSC. The representatives of the EC shall have one vote in the JSC. Decisions of 

the JSC shall be made by unanimous consent. In the event of disagreement 

either the U.S. or EC representatives may raise the matter in the Joint Committee. 

3.3. The JSC may address any matter related to the effective functioning of this 

Sectoral Annex, including: 

(a) providing a forum for discussion of issues and resolving problems that may 

arise concerning the implementation of this Sectoral Annex; 

(b) developing a mechanism for ensuring consistency of interpretations of 

legislation, regulations, standards, and conformity assessment procedures; 

(c) advising the Parties on matters relating to this Sectoral Annex; 

(d) providing guidance and, if necessary, developing guidelines during the 

transitional period to facilitate the successful completion of the transitional 

period. 

CE/USA/Annex/en 28 
U.S. - EC MRA Electromagnetic Compatibility Annex 

4. CONTACT POINT 

Each Party shall establish a contact point to provide answers to all reasonable 

inquiries from the other Party regarding procedures, regulations and complaints 

under this Sectoral Annex. 

5. REGULATORY CHANGES AND UPDATING THE SECTORAL ANNEX 

In the event that there are changes to the legislative, regulatory and 

administrative provisions referenced in Section I or the introduction of new 

legislative, regulatory and administrative provisions affecting either Party's 

conformity assessment procedures under the Agreement, such changes shall 

take effect for the purpose of this Sectoral Annex at the same time they take 

effect domestically within the territory of each Party. The Parties shall update this 

Sectoral Annex to reflect the changes. 

CE/USA/Annex/en 29 
U.S. - EC MRA Electromagnetic Compatibility Annex 

SECTION VIII 

TRANSITIONAL ARRANGEMENT 

1. There shall be a transitional period of 24 months. 

2. The purpose of this transitional arrangement is to provide a means whereby the 

Parties to the Agreement can build confidence in and understanding of each 

others system for designating and listing conformity assessment bodies and in the 

ability of these bodies to test and certify products. Successful completion of the 

transition arrangement should result in the determination that conformity 

assessment bodies listed in Section V comply with the applicable criteria and are 

competent to conduct conformity assessment activities on behalf of the other 

Party. Upon completion of the transition period, the results of conformity 

assessment procedures performed by the exporting Party's conformity assessment 

bodies listed in Section V shall be accepted by the importing Party. 

3. This transitional period shall be used by the Parties: 

(a) to consider new legislative changes needed to support the objectives of the 

Agreement; 

(b) to initiate regulatory changes needed to support the objectives of the 

Agreement; 

CE/USA/Annex/en 30 
U.S. - EC MRA Electromagnetic Compatibility Annex 

(c) to exchange information on and develop better understanding of their 

respective regulatory requirements; 

(d) to develop mutually agreed mechanisms for exchanging information on 

changes in technical requirements or methods of designating conformity 

assessment bodies; and 

(e) to monitor and evaluate the performance of the listed conformity assessment 

bodies during the transitional period. 

4. Parties may designate, list, suspend and withdraw conformity assessment bodies 

during the transitional period according to the procedures in Section VI of this 

Sectoral Annex. 

5. During the transitional period each Party shall accept and evaluate test reports 

and related documents issued by designated conformity assessment bodies of 

the other Party. To this end, the Parties shall ensure that: 

(a) on receipt of test reports, related documents and a first evaluation of 

conformity, the dossiers are promptly examined for completeness; 

(b) the applicant is informed in a precise and complete manner of any 

deficiency; 

CE/USA/Annex/en 31 
U.S. - EC MRA Electromagnetic Compatibility Annex 

(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. 

6. Each Party ensures that issuance of approvals, certificates or advice to the 

applicant shall be given no later than six weeks from receipt of the test report 

and evaluation from a designated conformity assessment body in the territory of 

the other Party. 

7. Any proposal made during or at the end of the transitional period to limit the 

scope of recognition of any designated conformity assessment body or to 

exclude it from the list of bodies designated under this Sectoral Annex shall be 

based on objective criteria and documented. Any such body may apply for 

reconsideration once the necessary corrective action has been taken. To the 

extent possible, the Parties shall implement such action prior to the expiry of the 

transitional period. 

8. The Parties may jointly sponsor two seminars, one in U.S. and one in the European 

Community, concerning the relevant technical and product approval 

requirements during the first year after this Sectoral Annex enters into force. 

9. Passage from the transitional phase into the operational phase in this Sectoral 

Annex shall take place provided that a representative number of conformity 

assessment bodies have been accepted for recognition under the Electrical 

Safety Annex. 

CE/USA/Annex/en 32 
U.S. - EC MRA Electrical Safety Annex 

SECTORAL ANNEX 

FOR 

ELECTRICAL SAFETY 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition 

between the United States and the European Community. 

CE/USA/Annex/en 33 
U.S. - EC MRA Electrical Safety Annex 

SECTION I 

LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS 

U.S. access to the EC market: EC access to the U.S. market : 

Council Directive 73/23/EEC of 29 U.S.C. 651 et seq. 

19 February 1973 as amended U.S. 29 CFR 1910.7 

by Directive 98/13/EC of the 

European Parliament and of the Products that are certified or 

Council. 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. 

Occupational Safety and Health 

Administration (OSHA) will consider 

regulatory and legislative changes 

needed to support the objectives of 

the MRA. 

For medical devices, see the For medical devices, see the Medical 

Medical Devices Sectoral Devices Sectoral Annex to this 

Annex to this Agreement. Agreement. 

For electromagnetic For electromagnetic compatibility 

compatibility aspects, see the aspects, see the Electromagnetic 

Electromagnetic Compatibility Compatibility (EMC) Sectoral Annex 

(EMC) Sectoral Annex to this to this Agreement. 

Agreement. 

For telecommunication equipment, 

For telecommunication see the Telecommunication 

equipment, see the Equipment Sectoral Annex to this 

Telecommunication Equipment Agreement. 

Sectoral Annex to this 

Agreement. 

CE/USA/Annex/en 34 
U.S. - EC MRA Electrical Safety Annex 

SECTION II 

SCOPE AND COVERAGE 

U.S. access to the EC market: EC access to the U.S. market: 

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. 

The electrical safety requirements of 

products falling under the scope of 

29 CFR 1910 subpart S. This includes 

the electrical safety aspects for 

workplace safety of medical 

equipment and telecommunication 

terminal equipment within the scope 

of those Sectoral Annexes. 

Products that are certified or 

approved under the Federal Mine 

Safety and Health Act (30 U.S.C. 801 

et seq.) or its regulations and used in 

areas under the authority of the Mine 

Safety and Health Administration, are 

not covered under this Annex. 

CE/USA/Annex/en 35 
U.S. - EC MRA Electrical Safety Annex 

SECTION III 

DESCRIPTION OF MUTUAL RECOGNITION OBLIGATIONS 

In accordance with the provisions of the Agreement, EC conformity assessment bodies 

listed in Section V of this Annex shall be recognized to test, certify and mark products 

within the scope of their Nationally Recognised Testing Laboratory (NRTL) recognition 

for assessing conformity to U.S. requirements. 

With regard to U.S. conformity assessment bodies listed in Section V of this Annex, in the 

event of a challenge within the European Community under Article 8(2) of Council 

Directive 73/23/EEC of 19 February 1973, test reports issued by such conformity 

assessment bodies shall be accepted by the European Community Authorities in the 

same way that reports from European Community notified bodies are accepted. That 

is, (listed conformity assessment bodies) in the U.S. shall be recognized under Article 11 

of Council Directive 73/23/EEC as "bodies which may make a report in accordance 

with Article 8." 

CE/USA/Annex/en 36 
U.S. - EC MRA Electrical Safety Annex 

SECTION IV 

AUTHORITIES RESPONSIBLE FOR DESIGNATING THE 

CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V 

EC access to the U.S. market: U.S. access to the EC market: 

 Belgium 

Ministère des Affaires Economiques 

Ministerie van Economische Zaken 

 Denmark 

Boligministeriet 

 Germany 

Bundesministerium für Arbeit und Sozialordnung 

 Greece 

=ΞΩ]ΨΚΜΓΩ ∗ΥΔΞ∴]ςΟΖ 

Ministry of Development 

 Spain 

Ministerio de Industria y Energía 

 France 

Ministère de l'économie, des finances et de l'industrie 

 Ireland 

Department of Enterprise and 

Employment 

 Italy 

Ministero dell'Industria, del Commercio e 

dell' Artigianato 

 Luxembourg 

Ministère des Transports 

 Netherlands 

Staat der Nederlanden 

 Austria 

Bundesministerium für wirtschaftliche 

Angelegenheiten 

 Portugal 

Under the authority of the Government of Portugal: 

Instituto Português da Qualidade 

 Finland 

Kauppa- ja teollisuusministeriö/Handels-och 

industriministeriet 

 Sweden 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontroll 

(SWEDAC) 

 UK 

Department of Trade and Industry 

National Institute for Standards and Technology 

(NIST) 

CE/USA/Annex/en 37 
U.S. - EC MRA Electrical Safety Annex 

SECTION V 

CONFORMITY ASSESSMENT BODIES 

EC access to the U.S. market: U.S. access to the EC market: 

The names and scope of responsibilities of 

Conformity Assessment Bodies located in the 

EC and listed in accordance with this 

Sectoral Annex: 

(to be provided by the EC) 

The names and scope of responsibilities 

of Conformity Assessment Bodies 

located in the U.S. and listed in 

accordance with this Sectoral Annex: 

(to be provided by the U.S.) 

CE/USA/Annex/en 38 
U.S. - EC MRA Electrical Safety Annex 

SECTION VI 

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING 

CONFORMITY ASSESSMENT BODIES 

EC access to the U.S. market: U.S. access to the EC market: 

Conformity assessment bodies from the EC Conformity assessment bodies from 

shall be designated by the EC Authorities the U.S. shall be designated by the U.S. 

identified in Section IV and recognized by the Authority identified in Section IV and 

Joint Committee, in accordance with the recognized by the Joint Committee, in 

recognition procedures in the Agreement and accordance with the recognition 

this Annex. procedures in the Agreement and 

Council Directive 73/23/EEC. 

Conformance with the appropriate ISO/IEC Conformance with the appropriate 

Guides or the corresponding EN 45000 series EN-45000 series of standards or the 

of standards shall be deemed consistent with corresponding ISO/IEC Guides shall be 

U.S. requirements identified in Section I. deemed consistent with the 

requirements of Council 

Directive 73/23/EEC. 

For purposes of designation and listing, EC For purposes of designating and listing, 

Designating Authorities identified in Section IV the U.S. Designating Authority 

shall designate conformity assessment bodies identified in Section IV shall designate 

located in the EC by filing a properly conformity assessment bodies located 

prepared proposal for listing, which includes a in the U.S. by filing a properly prepared 

complete lab assessment under the U.S. OSHA proposal for listing with the EC, which 

procedures. OSHA shall notify the EC includes a complete lab assessment 

Designating Authority normally within 30 days under the following EC or Member 

as to whether the proposal is complete or State procedures, as appropriate. 

whether additional information is required. 

OSHA shall rely on the EC Designating The EC shall notify the U.S. Designating 

Authorities identified in Section IV for Authority within 30 days as to whether 

conducting on-site reviews at the respective the proposal is complete and shall 

Member States' conformity assessment indicate, where applicable, any 

bodies. additional information that is required. 

CE/USA/Annex/en 39 
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SECTION VI (continued) 

Upon receipt of a complete proposal, the U.S. Upon receipt of a complete proposal, 

exercising its authority under its law shall: the EC shall give notice of consent or 

objection to the Joint Committee 

(a) prior to the passage from the transitional within 60 days. The Joint Committee 

phase into the operational phase in the shall monitor the recognition of 

Telecommunication Equipment and conformity assessment bodies and 

Electromagnetic Compatibility (EMC) confirm such a recognition by listing 

Sectoral Annexes, give notice of its them in Section V of this Sectoral 

consent or objection to a proposed Annex. 

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 Telecommunication 

Equipment and Electromagnetic 

Compatibility (EMC) Sectoral Annexes, 

give notice of its consent or objection to a 

proposed conformity assessment body to 

the Joint Committee normally within 120 

business days. The listing of an agreed 

conformity assessment body in Section V 

of this Sectoral Annex shall occur upon 

notice of consent to the Joint Committee 

and the Joint Committee's decision to list 

such body. 

These listing procedures shall supersede the 

procedures in Article 7(c) of the Agreement in 

its entirety and the time periods set out in 

Article 7(d) of the Agreement. 

EC conformity assessment bodies listed in The U.S. conformity assessment bodies 

Section V shall have NRTL status in the U.S. listed in Section V shall have Notified 

Body status within the EC. 

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SECTION VI (continued) 

With regard to the suspension of a conformity 

assessment body listed in this Sectoral Annex, 

the period specified in Article 8(e) of the 

Agreement shall begin to run after a Party has 

notified the Joint Sectoral Committee or the 

Joint Committee, pursuant to Article 8(c) of 

the Agreement, that it proposes to revoke the 

conformity assessment body's recognition in 

accordance with its procedures under its 

applicable domestic law. 

Except as provided for in this Section, 

procedures for designation, listing, suspension 

and withdrawal of conformity assessment 

bodies under this Sectoral Annex shall be 

carried out in accordance with Articles 7, 8 

and 9 of the Agreement. 

CE/USA/Annex/en 41 
U.S. - EC MRA Electrical Safety Annex 

SECTION VII 

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 

and listing; 

 providing a forum for discussion of issues that may arise concerning the 

implementation of this Sectoral Annex; 

 advising the Parties on matters relating to this Sectoral Annex; and 

 enhancing the operation of this Sectoral Annex. 

CE/USA/Annex/en 42 
U.S. - EC MRA Recreational Craft Annex 

SECTORAL ANNEX 

FOR 

RECREATIONAL CRAFT 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition 

between the United States and the European Community. 

The purpose of this Sectoral Annex is to establish a framework to accept certificates of 

conformity issued in the territory of one Party in accordance with the regulatory 

requirements of the other Party as referenced in this Sectoral Annex. 

To facilitate that purpose, a transitional period of 18 months is arranged to build 

confidence as defined in this Sectoral Annex, Section VI. 

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SECTION I 

LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE 

REQUIREMENTS 

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. 

2. For the U.S.: 

46 U.S.C. Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58. 

SECTION II 

SCOPE AND COVERAGE 

1. This Sectoral Annex applies to all recreational craft which in the European 

Community or the United States are subject to conformity assessment by a 

conformity assessment body or an approval procedure, as applicable, before 

being put on the market. 

CE/USA/Annex/en 44 
U.S. - EC MRA Recreational Craft Annex 

2. The product coverage for each Party shall be determined by the following relevant 

requirements: 

(a) for the European Community: 

Recreational craft as defined in Directive 94/25/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 CFR 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 

Section I; 

(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 I. 

CE/USA/Annex/en 45 
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SECTION III 

AUTHORITIES RESPONSIBLE FOR DESIGNATING 

THE CONFORMITY ASSESSMENT BODIES 

EC access to the U.S. market: U.S. access to the EC market: 

 Belgium 

Ministère des Communications et de l'infrastructure 

Ministerie van Verkeer en Infrastructuur 

 Germany 

Bundesministerium für Wirtschaft 

 Spain 

for telecommunication equipment: 

Ministerio de Fomento 

for other equipment: 

Ministerio de Industria y Energía 

 France 

Ministère de l'Equipment, des Transports et du Logement 

Ministère de l’Economie, des Finances et de l’Industrie 

 Italy 

Ministero dell'Industria, del Commercio e dell' 

Artigianato 

 Netherlands 

De Minister van Verkeer en Waterstaat 

 Finland 

Merenkulkuhallitus/sjöfartsstyrelsen 

 Sweden 

Under the authority of the Government of Sweden: 

Styrelsen för ackreditering och teknisk kontroll (SWEDAC) 

 UK 

Department of Trade and Industry 

National Institute for Standards and Technology 

(NIST) 

CE/USA/Annex/en 46 
U.S. - EC MRA Recreational Craft Annex 

SECTION IV 

DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING 

CONFORMITY ASSESSMENT BODIES 

1. For the purpose of this Sectoral Annex, each Party shall designate competent 

conformity assessment bodies to carry out conformity assessment and approval to 

the requirements of the other Party. Such designation shall be carried out 

according to the procedures set out in Article 7 of the Agreement. A list of 

conformity assessment bodies together with the products and procedures for 

which they have been listed, is 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. 

requirements; 

(b) for the U.S., in accordance with the requirements set out in the regulations 

listed in Section I, 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. 

CE/USA/Annex/en 47 
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SECTION V 

CONFORMITY ASSESSMENT BODIES 

EC access to the U.S. market: U.S. access to the EC market: 

The names and scope of responsibilities of 

Conformity Assessment Bodies located in the 

EC and listed in accordance with this 

Sectoral Annex: 

(to be provided by EC) 

The names and scope of responsibilities 

of Conformity Assessment Bodies 

located in the U.S. and listed in 

accordance with this Sectoral Annex: 

(to be provided by the US) 

CE/USA/Annex/en 48 
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SECTION VI 

TRANSITIONAL ARRANGEMENT 

1. There shall be a transitional period of 18 months prior to the operations of this 

Sectoral Annex. 

2. The purpose of the transitional arrangement is to provide a means whereby the 

Parties to this Agreement can cooperate to establish a system for designating 

conformity assessment bodies and can mutually build confidence in the abilities 

of these bodies. Successful completion of this transitional arrangement is 

intended to result in a determination that conformity assessment bodies comply 

with the applicable criteria and to have the equipment approved by the 

conformity assessment bodies of the exporting country accepted by the 

approval authority of the importing country. 

3. During this transitional period, the parties shall: 

(a) exchange information on technical data and conformity assessment criteria 

and procedures, thus developing greater familiarity with their respective 

regulatory requirements; and 

(b) carry out or recommend any applicable policy, legislative and regulatory 

changes necessary for the provisions of this Annex. 

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4. Product Scope 

All products covered by Section II of this Annex. 

5. Cooperation 

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. 

6. Inspections 

Inspections or audits shall be permitted to verify compliance of conformity 

assessment bodies with their responsibilities under this Agreement. The scope of 

these inspections or audits shall be agreed upon in advance by both Parties. 

SECTION VII 

ADDITIONAL PROVISIONS 

1. In accordance with the relevant provisions of the Agreement, the Parties shall 

ensure the continued availability of the names of their respective notified bodies 

or conformity assessment bodies, and shall regularly supply details of certifications 

issued in order to facilitate post market surveillance. 

CE/USA/Annex/en 50 
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2. The Parties note that, to the extent that requirements for electrical safety or 

electromagnetic compatibility may apply to products covered by this Sectoral 

Annex, the provisions of the Sectoral Annexes on Electrical Safety and 

Electromagnetic Compatibility apply. 

SECTION VIII 

DEFINITIONS 

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. 

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U.S. - EC MRA Pharmaceutical Good Manufacturing Practices Annex 

SECTORAL ANNEX 

FOR 

PHARMACEUTICAL GOOD MANUFACTURING PRACTICES 

(GMPs) 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition 

between the United States and the European Community. 

CHAPTER 1 

DEFINITIONS, PURPOSE, SCOPE AND COVERAGE 

Article 1 

Definitions 

1. "Equivalence" of the regulatory systems means that the systems are sufficiently 

comparable to assure that the process of inspection and the ensuing inspection 

reports will provide adequate information to determine whether respective 

statutory and regulatory requirements of the authorities have been fulfilled. 

"Equivalence" does not require that the respective regulatory systems have 

identical procedures. 

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2. "Enforcement" means action taken by an authority to protect the public from 

products of suspect quality, safety and efficacy or to assure that products are 

manufactured in compliance with appropriate laws, regulations, standards and 

commitments made as part of the approval to market a product. 

3. "Good Manufacturing Practices" (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 

purports or is represented to possess. 

GMPs are that part of quality assurance which ensures that products are 

consistently produced and controlled to quality standards. For the purpose of this 

Annex, GMPs include therefore the system whereby the manufacturer receives 

the specifications of the product and/or process from the Marketing 

Authorization/Product Authorization or License holder or applicant and ensures 

the product is made in compliance with its specifications (Qualified Person 

certification in the EC). 

4. "Inspection" means an on-site evaluation of a manufacturing facility to 

determine whether such manufacturing facility is operating in compliance with 

Good Manufacturing Practices and/or commitments made as part of the 

approval to market a product. 

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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. 

Article 2 

Purpose 

The provisions of this Annex govern the exchange between the Parties and normal 

endorsement by the receiving authority of official Good Manufacturing Practices 

(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 

Annex. 

Article 3 

Scope 

The provisions of this Annex shall apply to pharmaceutical inspections carried out in the 

United States and Member States of the European Community before products are 

marketed (hereafter referred to as "pre-approval inspections") as well as during their 

marketing (hereafter referred to as "post-approval inspections"). 

CE/USA/Annex/en 54 
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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. 

Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex. 

Article 4 

Product coverage 

These provisions will apply to medicinal products for human or animal use, 

intermediates and starting materials (as referred to in the EC) 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. 

Appendix 3 contains an indicative list of products covered by this Annex. 

CE/USA/Annex/en 55 
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CHAPTER 2 

TRANSITION PERIOD 

Article 5 

Length of transition period 

A three-year transition period will start immediately after the effective date of the 

Agreement. 

Article 6 

Equivalence assessment 

1. The criteria to be used by the Parties to assess equivalence are listed in Appendix 

4. Information pertaining to the criteria under Community competence will be 

provided by the Community. 

2. The authorities of the parties will establish and communicate to each other their 

draft 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 

processes. 

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3. The equivalence assessment shall include information exchanges (including 

inspection reports), joint training, and joint inspections for the purpose of assessing 

regulatory systems and the authorities' capabilities. In conducting the 

equivalence assessment, the Parties will ensure that efforts are made to save 

resources. 

4. Equivalence assessment for authorities added to Appendix 2 after the effective 

date of this agreement will be conducted as described in this Annex, as soon as 

practicable. 

Article 7 

Participation in the equivalence assessment and determination 

The authorities listed in Appendix 2 will actively participate in these programs to build a 

sufficient body of evidence for their equivalence determination. Both parties will 

exercise good faith efforts to complete equivalence assessment as expeditiously as 

possible to the extent the resources of the authorities allow. 

Article 8 

Other transition activities 

As soon as possible, the authorities will jointly determine the essential information which 

must be present in inspection reports and will cooperate to develop mutually agreed 

inspection report format(s). 

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CHAPTER 3 

END OF TRANSITION PERIOD 

Article 9 

Equivalence determination 

Equivalence is established by having in place regulatory systems covering the criteria 

referred to in Appendix 4, and a demonstrated pattern of consistent performance in 

accordance with these criteria. A list of authorities determined as equivalent shall be 

agreed to by the Joint Sectoral Committee at the end of the transition period, with 

reference to any limitation in terms of inspection type (e.g. post-approval or 

pre-approval) or product classes or processes. 

The Parties will document insufficient evidence of equivalence, lack of opportunity to 

assess equivalence or a determination of non-equivalence, in sufficient detail to allow 

the authority being assessed to know how to attain equivalence. 

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Article 10 

Authorities not listed as currently equivalent 

Authorities not currently listed as equivalent, or not equivalent for certain types of 

inspections, product classes or processes may apply for reconsideration of their status 

once the necessary corrective measures have been taken or additional experience is 

gained. 

CHAPTER 4 

OPERATIONAL PERIOD 

Article 11 

Start of the operational period 

The operational period shall start at the end of the transition period and its provisions 

apply to inspection reports generated by authorities listed as equivalent for the 

inspections performed in their territory. 

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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. 

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Article 12 

Nature of recognition of inspection reports 

Inspection reports (containing information as established under Article 8), including a 

GMP compliance assessment, prepared by authorities listed as equivalent, will be 

provided to the authority of the importing Party. Based on the determination of 

equivalence in light of the experience gained, these inspection reports will normally be 

endorsed by the authority of the importing Party, except under specific and 

delineated circumstances. Examples of such circumstances include indications of 

material inconsistencies or inadequacies in an inspection report, quality defects 

identified in the post-market surveillance or other specific evidence of serious concern 

in relation to product quality or consumer safety. In such cases, the authority of the 

importing Party may request clarification from the authority of the exporting Party 

which may lead to a request for re-inspection. The authorities will 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. 

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Article 13 

Transmission of post-approval inspection reports 

Post-approval GMP inspection reports concerning products covered by this Annex will 

be transmitted to the authority of the importing country within 60 calendar days of the 

request. Should a new inspection be needed, the inspection report will be transmitted 

within 90 calendar days of the request. 

Article 14 

Transmission of pre-approval inspection reports 

A preliminary notification that an inspection may have to take place will be made as 

soon as possible. 

Within 15 calendar days, the relevant authority will acknowledge receipt of the request 

and confirm its ability to carry out the inspection. In the EC, requests will be sent 

directly to the relevant authority, with a copy to the European Agency for the 

Evaluation of Medicinal Products (EMEA). If the authority receiving the request cannot 

carry out the inspection as requested, the requesting authority shall have the right to 

conduct the inspection. 

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Reports of pre-approval inspections will be sent within 45 calendar days of the request 

that transmitted the appropriate information and detailed the precise issues to be 

addressed during the inspection. A shorter time may be necessary in exceptional 

cases and these will be described in the request. 

Article 15 

Monitoring continued equivalence 

Monitoring activities for the purpose of maintaining equivalence shall include review of 

the exchange of inspection reports and their quality and timeliness; performance of a 

limited number of joint inspections and the conduct of common training sessions. 

Article 16 

Suspension 

Each Party has the right to contest the equivalence of an authority. This right will be 

exercised in an objective and reasoned manner in writing to the other Party. 

The issue shall be discussed in the Joint Sectoral Committee promptly upon such 

notification. Where the JSC determines that verification of equivalence is required, it 

may be carried out jointly by the Parties in a timely manner, pursuant to Article 6. 

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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. 

CHAPTER 5 

JOINT SECTORAL COMMITTEE 

Article 17 

Role and composition of the Joint Sectoral Committee 

A Joint Sectoral Committee is set up to monitor the activities under both the transitional 

and operational phases of this Annex. 

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The Committee will be co-chaired 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 

unanimous consent. 

The Joint Sectoral Committee's functions will include: 

1. making a joint assessment, which must be agreed by both Parties, of the 

equivalence of the respective authorities, 

2. developing and maintaining the list of equivalent authorities, including any 

limitation in terms of inspecting type or products, and communicating the list to all 

authorities and the Joint Committee, 

3. providing a forum to discuss issues relating to this Annex, including concerns that 

an authority may be no longer equivalent and opportunity to review product 

coverage, 

4. consideration of the issue of suspension. 

The Joint Sectoral Committee shall meet at the request of either Party and, unless the 

co-chairs otherwise agree, at least once each year. The Joint Committee will be kept 

informed of the agenda and conclusions of meetings of the Joint Sectoral Committee. 

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CHAPTER 6 

INFORMATION EXCHANGE 

Article 18 

Regulatory collaboration 

The Parties and authorities shall inform and consult one another, as permitted by law, 

on proposals to introduce new controls or to change existing technical regulations or 

inspection procedures and to provide the opportunity to comment on such proposals. 

The Parties shall notify each other in writing of any changes to Appendix 2. 

Article 19 

Information relating to quality aspects 

The authorities will establish an appropriate means of exchanging information on any 

confirmed problem reports, corrective actions, recalls, rejected import consignments 

and other regulatory and enforcement problems for products subject to this Annex. 

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Article 20 

Alert System 

The details of an alert system will be developed during the transitional period. The 

system will be maintained in place at all times. Elements to be considered in 

developing such a system are described in Appendix 5. 

Contact points will be agreed between both Parties to permit authorities to be made 

aware with the appropriate speed in case of quality defect, recalls, counterfeiting and 

other problems concerning quality, which could necessitate additional controls or 

suspension of the distribution of the product. 

CHAPTER 7 

SAFEGUARD CLAUSE 

Article 21 

Each Party recognizes that the importing country has a right to 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. 

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APPENDIX 1 

List of applicable laws, regulations and administrative provisions 

For the European Community: 

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid 

down by law, regulation or administrative action relating to proprietary medicinal 

products, as extended, widened and amended. 

Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid 

down by law, regulation or administrative action relating to proprietary medicinal 

products, as extended, widened and amended. 

Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws 

of the Member States relating to veterinary medicinal products, as widened and 

amended. 

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and 

guidelines of good manufacturing practice for medicinal products for human use. 

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and 

guidelines of good manufacturing practice for veterinary medicinal products. 

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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 

Products. 

Council Directive 92/25/EEC of 31 March 1992 on the wholesale distribution of 

medicinal products for human use. 

Guide to Good Distribution Practice (94/C 63/03). 

Current version of the Guide to Good Manufacturing Practice, Rules Governing 

Medicinal Products in the European Community, Volume IV. 

For the United States: 

Relevant sections of the United States Federal Food, Drug, and Cosmetic Act and the 

United States Public Health Service Act. 

Relevant sections of Title 21, United States Code of Federal Regulations (CFR) Parts 

1-99, Parts 200-299, Parts 500-599, and Parts 600-799. 

Relevant sections of the FDA Investigations Operations Manual, the FDA Regulatory 

Procedures Manual, the FDA Compliance Policy Guidance Manual, the FDA 

Compliance Program Guidance Manual, and other FDA guidances. 

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APPENDIX 2 

List of Authorities 

United States: 

In the United States, the regulatory authority is the Food and Drug Administration. 

European Community: 

In the European Community, the regulatory authorities are the following: 

BELGIUM Inspection générale de la Pharmacie 

Algemene Farmaceutische Inspectie 

DENMARK Laegemiddelstyrelsen 

GERMANY Bundesministerium für Gesundheit 

for immunologicals: 

Paul-Ehrlich-Institut, Federal Agency for Sera & Vaccines 

GREECE .ΠΥΘΡδΖ 8ΨΚΙΥΘ[ΤδΖ >ΙΨΤΔΡΩ] 

Ministry of Health and Welfare 

National Drug Organization (E.O.F.) 

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SPAIN for medicinal products for human use: 

Ministerio de Sanidad y Consumo 

Subdirección General de Control Farmacéutico 

for medicinal products for veterinary use: 

Ministerio de Agricultura, Pesca y Alimentación (MAPA) 

Dirección General de la Producción Agraria 

FRANCE for medicinal products for human use: 

Agence du Médicament 

for veterinary medicinal products: 

Agence Nationale du Médicament Vétérinaire 

IRELAND Irish Medicines Board 

ITALY for medicinal products for human use: 

Ministero della Sanità 

Dipartimento Farmaci e Farmacovigilanza 

for medicinal products for veterinary use: 

Ministero della Sanità 

Dipartimento alimenti e nutrizione e sanità pubblica 

veterinaria  Div. IX 

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LUXEMBOURG Division de la Pharmacie et des Médicaments 

NETHERLANDS Staat der Nederlanden 

AUSTRIA Bundesministerium für Arbeit, Gesundheit und Soziales 

PORTUGAL Instituto da Farmácia e do Medicamento  INFARMED 

FINLAND Lääkelaitos/Läkemedelsverket 

(National Agency for Medicines) 

SWEDEN Läkemedelsverket  Medical Products Agency 

UNITED KINGDOM for human and veterinary (non-immunologicals): 

Medicines Control Agency 

for veterinary immunologicals: 

Veterinary Medicines Directorate 

EUROPEAN COMMUNITY Commission of the European Communities 

European Agency for the Evaluation of Medicinal 

Products (EMEA) 

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APPENDIX 3 

Indicative list of Products covered by the Sectoral Annex 

Recognizing that precise definition of medicinal products and drugs are to be found in 

the 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). 

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APPENDIX 4 

Criteria for Assessing Equivalence for Post- and Pre-Approval 

I. Legal/Regulatory authority and structures and procedures providing for post- and 

pre-approval: 

A. Appropriate statutory mandate and jurisdiction. 

B. Ability to issue and update binding requirements on GMPs and guidance 

documents. 

C. Authority to make inspections, review and copy documents, and to take 

samples and collect other evidence. 

D. Ability to enforce requirements and to remove products found in violation of 

such requirements from the market. 

E. Substantive current good manufacturing requirements. 

F. Accountability of the regulatory authority. 

G. Inventory of current products and manufacturers. 

H. System for maintaining or accessing inspection reports, samples and other 

analytical data, and other firm/product information relating to matters 

covered by this Sectoral Annex. 

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II. Mechanisms in place to assure appropriate professional standards and 

avoidance of conflicts of interest. 

III. Administration of the regulatory authority: 

A. Standards of education/qualification and training. 

B. Effective quality assurance systems measures to ensure adequate job 

performance. 

C. Appropriate staffing and resources to enforce laws and regulations. 

IV. Conduct of Inspections: 

A. Adequate 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. 

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C. Adequate post-inspection activities, including completeness of inspectors’ 

report, inspection report review where appropriate, and conduct of 

follow-up inspections and other activities where appropriate, assurance of 

preservation and retrieval of records. 

V. Execution of regulatory enforcement actions to achieve corrections, designed to 

prevent future violations, and to remove products found in violation of 

requirements from the market. 

VI. Effective Use of Surveillance Systems: 

A. Sampling and analysis. 

B. Recall monitoring. 

C. Product defect reporting system. 

D. Routine surveillance inspections. 

E. Verification of approved manufacturing process changes to marketing 

authorizations/approved applications. 

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VII. Additional specific criteria for pre-approval inspections 

A. Satisfactory demonstration through a jointly developed and administered 

training program and joint inspections to assess the authorities’ capabilities. 

B. Pre-inspection preparation includes the review of appropriate records, 

including site plans and drug master file or similar documentation to enable 

adequate inspections. 

C. Ability to verify chemistry, manufacturing and control data supporting an 

application is authentic and complete. 

D. Ability to assess and evaluate research and development data as 

scientifically sound, especially transfer technology of pilot, scale up and full 

scale production batches. 

E. Ability to verify conformity of the on site processes and procedures with those 

described in the application. 

F. Review and evaluate equipment installation, operational and performance 

qualification data, and evaluate test method validation. 

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APPENDIX 5 

Elements to be Considered in Developing a Two-way Alert System 

1. Documentation 

 Definition of a crisis/emergency and under what circumstances an alert is 

required 

 Standard Operating Procedures (SOPs) 

 Mechanism of health hazards evaluation and classification 

 Language of communication and transmission of information 

2. Crisis Management System 

 Crisis analysis and communication mechanisms 

 Establishment of contact points 

 Reporting mechanisms 

3. Enforcement Procedures 

 Follow-up mechanisms 

 Corrective action procedures 

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4. Quality Assurance System 

 Pharmacovigilance programme 

 Surveillance/monitoring of implementation of corrective action 

5. Contact points 

For the purpose of this agreement, the contact points for the alert system will be: 

for the European Community: 

the Executive Director of the European Agency for the Evaluation of Medicinal 

Products, 7, Westferry Circus, Canary Wharf, UK  London E14 4HB, England. 

Telephone +44-171-418 8400, Fax 418 8416. 

for the United States: 

(to be provided by the U.S.) 

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SECTORAL ANNEX ON 

MEDICAL DEVICES 

PREAMBLE 

This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in 

Relation to Conformity Assessment between the United States and the European 

Community. 

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. 

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CHAPTER 1 

PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX 

Article 1 

Purpose 

1. The purpose of this Annex is to specify the conditions under which a Party will 

accept the results of quality system-related evaluations and inspections and 

premarket evaluations of the other Party with regard to medical devices as 

conducted by listed conformity assessment bodies (CABs) and to provide for 

other related cooperative activities. 

2. This Annex is intended to evolve as 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. 

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Article 2 

Scope 

1. The provisions of this Annex shall apply to the exchange and, where appropriate, 

endorsement of the following types of reports from CABs assessed to be 

equivalent: 

(a) Under the U.S. system, surveillance/post-market and initial/pre-approval 

inspection reports; 

(b) Under the U.S. system, premarket (510(k)) product evaluation reports; 

(c) Under the EC system, quality system evaluation reports; and 

(d) Under the EC system, EC type examination and verification reports. 

Appendix 1 names the legislation, regulations, and related procedures under 

which: 

(a) products are regulated as medical devices by each Party; 

(b) CABs are designated and confirmed; and 

(c) these reports are prepared. 

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2. For purposes of this Annex, equivalence means that: CABs in the EC are capable 

of conducting product and quality systems evaluations against U.S. regulatory 

requirements in a manner equivalent to those conducted by FDA; and CABs in 

the U.S. are capable of conducting product and quality systems evaluations 

against EC regulatory requirements in a manner equivalent to those conducted 

by EC CABs. 

Article 3 

Product Coverage 

There are three components to this agreement each covering a discrete range of 

products: 

1. Quality System Evaluations  U.S.-type surveillance/post-market and 

initial/pre-approval inspection reports and EC-type quality system evaluation 

reports will be exchanged with regard to all products regulated under both U.S. 

and EC law as medical devices. 

2. Product Evaluation  U.S.-type premarket (510(k)) product evaluation reports 

and EC-type-testing reports will be exchanged only with regard to those products 

classified under the U.S. system as Class I/Class II  Tier 2 medical devices which 

are listed in Appendix 2. 

3. Post-Market Vigilance Reports  Post-market vigilance reports will be exchanged 

with regard to all products regulated under both U.S. and EC law as medical 

devices. 

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Additional products and procedures may be made subject to this Annex by 

agreement of the Parties. 

Article 4 

Regulatory Authorities 

The regulatory authorities shall have the responsibility of implementing the provisions of 

this Annex, including the designation and monitoring of CABs. Regulatory authorities 

are specified in Appendix 3. Each Party will promptly notify the other Party in writing of 

any change in the regulatory authority for a country. 

CHAPTER 2 

TRANSITION PERIOD 

Article 5 

Length and purpose of transition period 

There will be a three-year transition period immediately following the date of entry into 

force of the Agreement. During the transition period, the Parties will engage in 

confidence-building activities for the purpose of obtaining sufficient evidence to make 

determinations concerning the equivalence of CABs of the other Party with respect to 

the ability to perform quality system and product evaluations or other reviews resulting 

in reports to be exchanged under this Annex. 

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Article 6 

Listing of CABs 

Each Party shall designate CABs to participate in confidence-building activities by 

transmitting to the other Party a list of CABs which meet the criteria for technical 

competence and independence, as identified in Appendix 1. The list shall be 

accompanied by supporting evidence. Designated CABs will be listed in Appendix 4 

for participation in the confidence building activities once confirmed by the importing 

Party. Non-confirmation would have to be justified based on documented evidence. 

Article 7 

Confidence Building Activities 

1. At the beginning of the transitional period, the Joint Sectoral Group will establish a 

joint confidence building 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. 

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2. The joint confidence building program should include the following actions and 

activities: 

(a) Seminars designed to inform the Parties and CABs about each Party's 

regulatory system, procedures, and requirements; 

(b) Workshops designed to provide the Parties with information regarding 

requirements and procedures for the designation and surveillance of CABs; 

(c) Exchange of information about reports prepared during the transition period; 

(d) Joint training exercises; and 

(e) Observed inspections. 

3. During the transition period, any significant problem that is identified with a CAB 

may be the subject of cooperative activities, as resources allow and as agreed to 

by the regulatory authorities, aimed at resolving the problem. 

4. Both Parties will exercise good faith efforts to complete the confidence building 

activities as expeditiously as possible to the extent that the resources of the Parties 

allow. 

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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. 

Article 8 

Other transition period activities 

1. During the transition period, the Parties will jointly determine the necessary 

information which must be present in quality system and product evaluation 

reports. 

2. The Parties will jointly develop a notification and alert system to be used in case of 

defects, recalls, and other problems concerning product quality that could 

necessitate additional actions (e.g., inspections by the Parties of the importing 

country) or suspension of the distribution of the product. 

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CHAPTER 3 

END OF TRANSITION PERIOD 

Article 9 

Equivalence Assessment 

1. In the final six months of the transition period, the Parties shall proceed to a joint 

assessment of the equivalence of the CABs that participated in the confidence 

building activities. CABs will be determined to be equivalent provided they have 

demonstrated proficiency through the submission of a sufficient number of 

adequate reports. CABs may be determined to be equivalent with regard to the 

ability to perform any type of quality system or product evaluation covered by 

this Annex and with regard to any type of product covered by this Annex. The 

parties shall develop a list contained in Appendix 5 of CABs determined to be 

equivalent which shall contain a full explanation of the scope of the equivalency 

determination, including any appropriate limitations, with regard to performing 

any type of quality system or product evaluation. 

2. The Parties shall allow CABs not listed for participation in the MRA, or listed for 

participation only as to certain types of evaluations, to apply for participation in 

this MRA once the necessary measures have been taken or sufficient experience 

has been gained, in accordance with Article 16. 

3. Decisions concerning the equivalence of CABs must be agreed to by both 

Parties. 

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CHAPTER 4 

OPERATIONAL PERIOD 

Article 10 

Start of the operational period 

1. The operational period will start at the end of the transition period after the Parties 

have developed the list of CABs found to be equivalent. The provisions of this 

Chapter will apply only with regard to listed CABs and only to the extent of any 

specifications and limitations contained on the list with regard to a CAB. 

2. The operational period will apply to quality system evaluation reports and product 

evaluation reports generated by CABs listed in accordance with this Annex for 

the evaluations performed in the respective territories of the Parties, except if the 

Parties agree otherwise. 

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Article 11 

Exchange and endorsement of quality system evaluation reports 

1. Listed EC CABs will provide FDA with reports of quality system evaluations, as 

follows: 

(a) For pre-approval quality system evaluations, EC CABs will provide full reports; 

and 

(b) For surveillance quality system evaluations, EC CABs will provide abbreviated 

reports. 

2. Listed U.S. CABs will provide to the EC Notified Body of the manufacturer’s choice: 

(a) Full reports of initial quality system evaluations; 

(b) Abbreviated reports of quality systems surveillance audits. 

3. If the abbreviated reports do not provide sufficient information, the importing 

Party may request additional clarification from the CAB. 

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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. 

Article 12 

Exchange and endorsement of product evaluation reports 

1. EC CABs listed for this purpose will, subject to the specifications and limitations on 

the list, provide to the FDA 510(k) premarket notification assessment reports 

prepared to U.S. medical device requirements. 

2. U.S. CABs will, subject to the specifications and limitations on the list, provide to 

the EC notified body of the manufacturer’s choice, type examination and 

verification reports prepared to EC medical device requirements. 

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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. 

Article 13 

Transmission of quality system evaluation reports 

Quality system evaluation reports covered by Article 11 concerning products covered 

by this Annex shall be transmitted to the importing Party within 60 calendar days of a 

request by the importing Party. Should a new inspection be requested the time period 

shall be extended by an additional 30 calendar days. A Party may request a new 

inspection, for cause, identified to the other Party. If the exporting Party cannot 

perform an inspection within a specified period of time, the importing Party may 

perform an inspection on its own. 

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Article 14 

Transmission of product evaluation reports 

Transmission of product evaluation reports will take place according to the importing 

Party's specified procedures. 

Article 15 

Monitoring continued equivalence 

Monitoring activities will be carried out in accordance with Article 10 of the 

Agreement. 

Article 16 

Listing of Additional CABs 

1. During the operational 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. 

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3. Following such annual designations, the procedures for confirmation of CABs 

under Articles 7(c) and (d) of the Agreement shall apply. 

CHAPTER 5 

JOINT SECTORAL COMMITTEE 

Article 17 

Role and composition of the Joint Sectoral Committee 

1. A Joint Sectoral Management Committee is set up to monitor the activities under 

both the transitional and operational phases of this Annex. 

2. The Committee will be co-chaired by a representative of the FDA for the U.S. and 

a representative of the EC who will each have one vote. Decisions will be taken 

by unanimous consent. 

3. The JSC's functions will include: 

(a) making a joint assessment of the equivalence of CABs; 

(b) developing and maintaining the list of equivalent CABs, including any 

limitation in terms of their scope of activities and communicating the list to all 

authorities and the Joint Committee; 

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(c) providing a forum to discuss issues relating to this Annex, including concerns 

that a CAB may no longer be equivalent and opportunity to review product 

coverage; and 

(d) consideration of the issue of suspension. 

CHAPTER 6 

HARMONIZATION AND INFORMATION EXCHANGE 

Article 18 

Harmonization 

During both the transitional and operational phases of this Agreement, both Parties 

intend to continue to participate in the activities of the Global Harmonization Task 

Force and utilize the results of those activities to the extent possible. Such participation 

involves developing and reviewing documents developed by the Global 

Harmonization Task Force and jointly determining whether they are applicable to the 

implementation of this Agreement. 

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Article 19 

Regulatory cooperation 

The Parties and authorities shall inform and consult with one another, as permitted by 

law, of proposals to introduce new controls or to change existing technical regulations 

or inspection procedures and to provide the opportunity to comment on such 

proposals. 

The Parties shall notify each other in writing of any changes to Appendix 1. 

Article 20 

Alert system and exchange of post-market vigilance reports 

1. An alert system will be set up during the transition period and maintained 

thereafter by which the Parties will notify each other when there is an immediate 

danger to public health. Elements of such a system will be described in an 

Appendix to be attached to this Sectoral Annex. As part of that system, each 

Party shall notify the other Party of any confirmed problem reports, corrective 

actions, or recalls. These reports are regarded as part of ongoing investigations. 

2. Contact points will be agreed between both Parties to permit authorities to be 

made aware with the appropriate speed in case of quality defect, batch recalls, 

counterfeiting and other problems concerning quality, which could necessitate 

additional controls or suspension of the distribution of the product. 

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APPENDIX 1 

RELEVANT LEGISLATION, REGULATIONS AND PROCEDURES 

1. For the European 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. 

Conformity assessment procedures. 

*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. 

Conformity assessment procedures. 

*Annex II (with the exception of section 4) 

*Annex III 

*Annex IV 

*Annex V 

*Annex VI 

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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. §§ 321 et seq. 

(b) The Public Health Service Act, 42 U.S.C. §§ 201 et seq. 

(c) Regulations of the United States Food and Drug Administration found at 

21 C.F.R., in particular, Parts 800 to 1299. 

(d) Medical Devices; Third-Party Review of Selected Premarket Notifications; 

Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3, 1996). 

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APPENDIX 2 

SCOPE OF PRODUCT COVERAGE 

1. Initial Coverage of the Transition Period: 

Upon entry into force of this Annex, (1

) products qualifying for the transitional 

arrangements under this Agreement include: 

(a) All Class I products requiring premarket evaluations in the United States 

see Table 1. 

(b) Those Class II products listed in Table 2. 

2. During the Transition Period: 

The Parties will jointly identify additional product groups, including their related 

accessories, in line with their respective priorities as follows: 

(a) Those for which review may be based primarily on written guidance which 

the Parties will use their best efforts to prepare expeditiously; and 

(

1

) It is understood that the date of entry into force will not occur prior to 1 June 1998, 

unless the Parties decide otherwise. 

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(b) Those for which review may be based primarily on international standards, in 

order for the Parties to gain the requisite experience. 

The corresponding additional product lists will be phased in on an annual basis. 

The Parties may consult with industry and other interested Parties in determining 

which products will be added. 

3. Commencement of the Operational Period: 

(a) At the commencement of the operational period, product coverage shall 

extend to all Class I/II products covered during the transition period. 

(b) FDA will expand the program to categories of Class II devices as is consistent 

with the results of the pilot, and with the FDA’s ability to write guidance 

documents if the device pilot for the third party review of medical devices is 

successful. The MRA will cover to the maximum extent feasible all Class II 

devices listed in Table 3 for which FDA-accredited third-party review is 

available in the U.S. 

4. Unless explicitly included by joint decision of the Parties, this agreement does not 

cover any U.S. Class II-tier 3 or any Class III product under either system. 

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TABLE 1 

CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS 

IN THE UNITED STATES, INCLUDED IN SCOPE OF PRODUCT COVERAGE 

AT BEGINNING OF TRANSITION PERIOD 

ANESTHESIOLOGY PANEL (868) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

868.1910 ESOPHAGEAL STETHOSCOPE 

BZW  STETHOSCOPE, ESOPHAGEAL 

868.5620 BREATHING MOUTHPIECE 

BYP  MOUTHPIECE, BREATHING 

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868.5640 MEDICINAL NONVENTILATORY NEBULIZER (ATOMIZER) 

CCQ  NEBULIZER, MEDICINAL, NON-VENTILATORY 

(ATOMIZER) 

868.5675 REBREATHING DEVICE 

BYW  DEVICE, REBREATHING 

868.5700 NONPOWERED OXYGEN TENT 

FOG  HOOD, OXYGEN, INFANT 

BYL  TENT, OXYGEN 

868.6810 TRACHEOBRONCHIAL SUCTION CATHETER 

BSY  CATHETERS, SUCTION, TRACHEOBRONCHIAL 

CARDIOVASCULAR PANEL 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

(NONE) 

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DENTAL PANEL (872) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

872.3400 KARAYA AND SODIUM BORATE WITH OR WITHOUT ACACIA 

DENTURE ADHESIVE KOM  ADHESIVE, DENTURE, ACACIA 

AND KARAYA WITH SODIUM BORATE 

872.3700 DENTAL MERCURY (U.S.P) 

ELY  MERCURY 

872.4200 DENTAL HANDPIECES AND ACCESSORIES 

EBW  CONTROLLER, FOOD, HANDPIECE AND CORD 

EFB  HANDPIECE, AIR-POWERED, DENTAL 

EFA  HANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL 

EGS  HANDPIECE, CONTRA- AND RIGHT-ANGLE 

ATTACHMENT, DENTAL 

EKX  HANDPIECE, DIRECT DRIVE, AC-POWERED 

EKY  HANDPIECE, WATER-POWERED 

872.6640 DENTAL OPERATIVE UNIT 

EIA  UNIT, OPERATIVE DENTAL 

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EAR, NOSE, AND THROAT PANEL (874) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

874.1070 SHORT INCREMENT SENSITIVITY INDEX (SISI) ADAPTER 

ETR  ADAPTER, SHORT INCREMENT SENSITIVITY INDEX (SISI) 

874.1500 GUSTOMETER 

ETM  GUSTOMETER 

874.1800 AIR OR WATER CALORIC STIMULATOR 

KHH  STIMULATOR, CALORIC-AIR 

ETP  STIMULATOR, CALORIC-WATER 

874.1925 TOYNBEE DIAGNOSTIC TUBE 

ETK  TUBE, TOYNBEE DIAGNOSTIC 

CE/USA/Annex/en 104 
U.S. - EC MRA Medical Devices Annex 

874.3300 HEARING AID 

LRB  FACE PLATE HEARING-AID 

ESD  HEARING-AID, AIR-CONDUCTION 

874.4100 EPISTAXIS BALLOON 

EMX  BALLOON, EPISTAXIS 

874.5300 ENT EXAMINATION AND TREATMENT UNIT 

ETF  UNIT, EXAMINING/TREATMENT, ENT 

874.5550 POWERED NASAL IRRIGATOR 

KMA  IRRIGATOR, POWERED NASAL 

874.5840 ANTI-STAMMERING DEVICE 

KTH  DEVICE, ANTI-STAMMERING 

CE/USA/Annex/en 105 
U.S. - EC MRA Medical Devices Annex 

GASTROENTEROLOGY  UROLOGY PANEL (876) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

876.5160 UROLOGICAL CLAMPS FOR MALES 

FHA  CLAMP, PENILE 

876.5210 ENEMA KIT 

FCE  KIT, ENEMA, (FOR CLEANING PURPOSE) 

876.5250 URINE COLLECTOR AND ACCESSORIES 

FAQ  BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE 

GENERAL HOSPITAL PANEL (880) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

880.5270 NEONATAL EYE PAD 

FOK  PAD, NEONATAL EYE 

CE/USA/Annex/en 106 
U.S. - EC MRA Medical Devices Annex 

880.5420 PRESSURE INFUSER FOR I.V. BAG 

KZD  INFUSOR, PRESSURE, FOR I.V. BAGS 

880.5680 PEDIATRIC POSITION HOLDER 

FRP  HOLDER, INFANT POSITION 

880.6250 PATIENT EXAMINATION GLOVE 

LZB  FINGER COT 

FMC  GLOVE, PATIENT EXAMINATION 

LYY  GLOVE, PATIENT EXAMINATION, LATEX 

LZA  GLOVE, PATIENT EXAMINATION, POLY 

LZC  GLOVE, PATIENT EXAMINATION, SPECIALITY 

LYZ  GLOVE, PATIENT EXAMINATION, VINYL 

880.6375 PATIENT LUBRICANT 

KMJ  LUBRICANT, PATIENT 

880.6760 PROTECTIVE RESTRAINT 

BRT  RESTRAINT, PATIENT, CONDUCTIVE 

FMQ  RESTRAINT, PROTECTIVE 

CE/USA/Annex/en 107 
U.S. - EC MRA Medical Devices Annex 

NEUROLOGY PANEL (882) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

882.1030 ATAXIAGRAPH 

GWW  ATAXIAGRAPH 

882.1420 ELECTROENCEPHALOGRAM (EEG) SIGNAL SPECTRUM 

ANALYZER 

GWS  ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM 

SIGNAL 

882.4060 VENTRICULAR CANNULA 

HCD  CANNULA, VENTRICULAR 

882.4545 SHUNT SYSTEM IMPLANTATION INSTRUMENT 

GYK  INSTRUMENT, SHUNT SYSTEM IMPLANTATION 

882.4650 NEUROSURGICAL SUTURE NEEDLE 

HAS  NEEDLE, NEUROSURGICAL SUTURE 

882.4750 SKULL PUNCH 

GXJ  PUNCH, SKULL 

CE/USA/Annex/en 108 
U.S. - EC MRA Medical Devices Annex 

OBSTETRICS AND GYNECOLOGY PANEL 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

(NONE) 

OPHTHALMOLOGY PANEL (886) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

886.1780 RETINOSCOPE 

HKM  RETINOSCOPE, BATTERY-POWERED 

886.1940 TONOMETER STERILIZER 

HKZ  STERILIZER, TONOMETER 

CE/USA/Annex/en 109 
U.S. - EC MRA Medical Devices Annex 

886.4070 POWERED CORNEAL BURR 

HQS  BURR, CORNEAL, AC-POWERED 

HOG  BURR, CORNEAL, BATTERY-POWERED 

HRG  ENGINE, TREPHINE, ACCESSORIES, AC-POWERED 

HFR  ENGINE, TREPHINE, ACCESSORIES, BATTERY-POWERED 

HLD  ENGINE, TREPHINE, ACCESSORIES, GAS-POWERED 

886.4300 KERATONE 

HNO  KERATONE, AC-POWERED 

HMY  KERATONE, BATTERY-POWERED 

886.5850 SUNGLASSES (NON-PRESCRIPTION) 

HQY  SUNGLASSES (NON-PRESCRIPTION INCLUDING 

PHOTOSENSITIVE) 

ORTHOPEDIC PANEL (888) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

888.1500 AC-POWERED GONIOMETER 

KQX  GONIOMETER, AC-POWERED 

888.4150 CALLIPERS FOR CLINICAL USE 

KTZ  CALLIPER 

CE/USA/Annex/en 110 
U.S. - EC MRA Medical Devices Annex 

PHYSICAL MEDICINE PANEL (890) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

890.3850 MECHANICAL WHEELCHAIR 

LBE  STROLLER, ADAPTIVE 

IOR  WHEELCHAIR, MECHANICAL 

890.5180 MANUAL PATIENT ROTATION BED 

INY  BED, PATIENT ROTATION, MANUAL 

890.5710 HOT OR COLD DISPOSABLE PACK 

IMD  PACK, HOT OR COLD, DISPOSABLE 

CE/USA/Annex/en 111 
U.S. - EC MRA Medical Devices Annex 

RADIOLOGY PANEL (892) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

892.1100 SCINTILLATION GAMMA CAMERA 

IYX  CAMERA, SCINTILLATION (GAMMA) 

892.1110 POSITRON CAMERA 

IZC  CAMERA, POSITRON 

892.1300 NUCLEAR RECTILINEAR SCANNER 

IYW  SCANNER, RECTILINEAR, NUCLEAR 

892.1320 NUCLEAR UPTAKE PROBE 

IZD  PROBE, UPTAKE, NUCLEAR 

892.1330 NUCLEAR WHOLE BODY SCANNER 

JAM  SCANNER, WHOLE BODY, NUCLEAR 

892.1410 NUCLEAR ELECTROCARDIOGRAPH SYNCHRONIZER 

IVY  SYNCHRONIZER, ELECTROCARDIOGRAPH, NUCLEAR 

CE/USA/Annex/en 112 
U.S. - EC MRA Medical Devices Annex 

892.1890 RADIOGRAPHIC-FILM ILLUMINATOR 

IXC  ILLUMINATOR, RADIOGRAPHIC-FILM 

JAG  ILLUMINATOR, RADIOGRAPHIC-FILM, 

EXPLOSION-PROOF 

892.1910 RADIOGRAPHIC GRID 

IXJ  GRID, RADIOGRAPHIC 

892.1960 RADIOGRAPHIC INTENSIFYING SCREEN 

WAM  SCREEN, INTENSIFYING, RADIOGRAPHIC 

892.1970 RADIOGRAPHIC ECG/RESPIRATOR SYNCHRONIZER 

IXO  SYNCHRONIZER, ECG/RESPIRATOR, RADIOGRAPHIC 

892.5650 MANUAL RADIONUCLIDE APPLICATOR SYSTEM 

IWG  SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL 

CE/USA/Annex/en 113 
U.S. - EC MRA Medical Devices Annex 

GENERAL AND PLASTIC SURGERY PANEL (878) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

878.4200 INTRODUCTION/DRAINAGE CATHETER AND ACCESSORIES 

KGZ  ACCESSORIES, CATHETER 

GCE  ADAPTOR, CATHETER 

FGY  CANNULA, INJECTION 

GBA  CATHETER, BALLOON TYPE 

GBZ  CATHETER, CHOLANGIOGRAPHY 

GBQ  CATHETER, CONTINUOUS IRRIGATION 

GBY  CATHETER, EUSTACHIAN, GENERAL & PLASTIC 

SURGERY 

JCY  CATHETER, INFUSION 

GBX  CATHETER, IRRIGATION 

GBP  CATHETER, MULTIPLE LUMEN 

GBO  CATHETER, NEPHROSTOMY, GENERAL & PLASTIC 

SURGERY 

GBN  CATHETER, PEDIATRIC, GENERAL & PLASTIC SURGERY 

GBW  CATHETER, PERITONEAL 

CE/USA/Annex/en 114 
U.S. - EC MRA Medical Devices Annex 

GBS  CATHETER, VENTRICULAR, GENERAL & PLASTIC 

SURGERY 

GCD  CONNECTOR, CATHETER 

GCC  DILATOR, CATHETER 

GCB  NEEDLE, CATHETER 

878.4320 REMOVABLE SKIN CLIP 

FZQ  CLIP, REMOVABLE (SKIN) 

878.4460 SURGEON’S GLOVES 

KGO  SURGEON’S GLOVES 

878.4680 NONPOWERED, SINGLE PATIENT, PORTABLE SUCTION 

APPARATUS 

GCY  APPARATUS, SUCTION, SINGLE PATIENT USE, 

PORTABLE, NONPOWERED 

878.4760 REMOVABLE SKIN STAPLE 

GDT  STAPLE, REMOVABLE (SKIN) 

CE/USA/Annex/en 115 
U.S. - EC MRA Medical Devices Annex 

GENERAL AND PLASTIC SURGERY PANEL (878) (CONTINUED) 

Section Regulation Name 

No. Product Code  Device Name 

************ 

************************************************************************************ 

878.4820 AC-POWERED, BATTERY-POWERED, AND PNEUMATICALLY 

POWERED SURGICAL INSTRUMENT MOTOR 

GFG  BIT, SURGICAL 

GFA  BLADE, SAW, GENERAL 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 

POWERED 

DWI  SAW, ELECTRICALLY POWERED 

KFK  SAW, PNEUMATICALLY POWERED 

HAB  SAW, POWERED, AND ACCESSORIES 

CE/USA/Annex/en 116 
U.S. - EC MRA Medical Devices Annex 

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, 

AC-POWERED 

880.5090 LIQUID BANDAGE 

KMF  BANDAGE, LIQUID 

CE/USA/Annex/en 117 
U.S. - EC MRA Medical Devices Annex 

TABLE 2 

CLASS II MEDICAL DEVICES INCLUDED 

IN SCOPE OF PRODUCT COVERAGE 

AT BEGINNING OF TRANSITION PERIOD 

U.S. to develop guidance documents identifying U.S. requirements and EC to identify 

standards needed to meet EC requirements 

RA 892.1000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE 

MOS  COIL, MAGNETIC RESONANCE, SPECIALTY 

LNH  SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING 

LNI  SYSTEM, NUCLEAR MAGNETIC RESONANCE 

SPECTROSCOPIC 

Diagnostic Ultrasound: 

RA 892.1540 NONFETAL ULTRASONIC MONITOR 

JAF  MONITOR, ULTRASONIC, NONFETAL 

RA 892.1550 ULTRASONIC PULSED DOPPLER IMAGING SYSTEM 

IYN  SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC 

RA 892.1560 ULTRASONIC PULSED ECHO IMAGING SYSTEM 

IYO  SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC 

RA 892.1570 DIAGNOSTIC ULTRASONIC TRANSDUCER 

ITX  TRANSDUCER, ULTRASONIC, DIAGNOSTIC 

CE/USA/Annex/en 118 
U.S. - EC MRA Medical Devices Annex 

Diagnostic X-Ray Imaging Devices (except mammographic x-ray systems): 

RA 892.1600 ANGIOGRAPHIC X-RAY SYSTEM 

IZI  SYSTEM, X-RAY, ANGIOGRAPHIC 

RA 892.1650 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM 

MQB  SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL 

IMAGER) 

JAA  SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED 

RA 892.1680 STATIONARY X-RAY SYSTEM 

KPR  SYSTEM, X-RAY, STATIONARY 

RA 892.1720 MOBILE X-RAY SYSTEM 

IZL  SYSTEM, X-RAY, MOBILE 

RA 892.1740 TOMOGRAPHIC X-RAY SYSTEM 

IZF  SYSTEM, X-RAY, TOMOGRAPHIC 

RA 892.1750 COMPUTED TOMOGRAPHY X-RAY SYSTEM 

JAK  SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED 

CE/USA/Annex/en 119 
U.S. - EC MRA Medical Devices Annex 

ECG-Related Devices: 

CV 870.2340 ELECTROCARDIOGRAPH 

DPS  ELECTROCARDIOGRAPH 

MLC  MONITOR, ST SEGMENT 

CV 870.2350 ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR 

DRW  ADAPTOR, LEAD SWITCHING, ELECTROCARDIOGRAPH 

CV 870.2360 ELECTROCARDIOGRAPH ELECTRODE 

DRX  ELECTRODE, ELECTROCARDIOGRAPH 

CV 870.2370 ELECTROCARDIOGRAPH SURFACE ELECTRODE TESTER 

KRC  TESTER, ELECTRODE, SURFACE, ELECTROCARDIOGRAPHIC 

NE 882.1400 ELECTROENCEPHALOGRAPH 

GWQ  ELECTROENCEPHALOGRAPH 

CE/USA/Annex/en 120 
U.S. - EC MRA Medical Devices Annex 

HO 880.5725 INFUSION PUMP (external only) 

MRZ  ACCESSORIES, PUMP, INFUSION 

FRN  PUMP, INFUSION 

LZF  PUMP, INFUSION, ANALYTICAL SAMPLING 

MEB  PUMP, INFUSION, ELASTOMERIC 

LZH  PUMP, INFUSION, ENTERAL 

MHD  PUMP, INFUSION, GALLSTONE DISSOLUTION 

LZG  PUMP, INFUSION, INSULIN 

MEA  PUMP, INFUSION, PCA 

Ophthalmic Instruments: 

OP 886.1570 OPHTHALMOSCOPE 

HLI  OPHTHALMOSCOPE, AC-POWERED 

HLJ  OPHTHALMOSCOPE, BATTERY-POWERED 

OP 886.1780 RETINOSCOPE 

HKL  RETINOSCOPE, AC-POWERED 

OP 886.1850 AC-POWERED SLIT-LAMP BIOMICROSCOPE 

HJO  BIOMICROSCOPE, SLIT-LAMP, AC-POWERED 

OP 886.4150 VITREOUS ASPIRATION AND CUTTING INSTRUMENT 

MMC  DILATOR, EXPANSIVE IRIS (ACCESSORY) 

CE/USA/Annex/en 121 
U.S. - EC MRA Medical Devices Annex 

HQE  INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, 

AC-POWERED 

HKP  INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, 

BATTERY-POWERED 

MLZ  VITRECTOMY, INSTRUMENT CUTTER 

OP 886.4670 PHACOFRAGMENTATION SYSTEM 

HQC  UNIT, PHACOFRAGMENTATION 

SU 878.4580 SURGICAL LAMP 

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 

CE/USA/Annex/en 122 
U.S. - EC MRA Medical Devices Annex 

NE 882.5890 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN 

RELIEF 

GZJ  STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF 

Noninvasive Blood Pressure Measurement Devices: 

CV 870.1120 BLOOD PRESSURE CUFF 

DXQ  CUFF, BLOOD-PRESSURE 

CV 870.1130 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM 

(except non-oscillometric) 

DXN  SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE 

HO 880.6880 STEAM STERILIZER (greater than 2 cubic feet) 

FLE  STERILIZER, STEAM 

Clinical Thermometers: 

HO 880.2910 CLINICAL ELECTRONIC THERMOMETER (except tympanic or 

pacifier) 

FLL  THERMOMETER, ELECTRONIC, CLINICAL 

AN 868.5630 NEBULIZER 

CAF  NEBULIZER (DIRECT PATIENT INTERFACE) 

AN 868.5925 POWERED EMERGENCY VENTILATOR 

CE/USA/Annex/en 123 
U.S. - EC MRA Medical Devices Annex 

Hypodermic Needles and Syringes (except anti-stick and self-destruct): 

HO 880.5570 HYPODERMIC SINGLE LUMEN NEEDLE 

MMK  CONTAINER, SHARPES 

FMI  NEEDLE, HYPODERMIC, SINGLE LUMEN 

MHC  PORT, INTRAOSSEOUS, IMPLANTED 

HO 880.5860 PISTON SYRINGE 

FMF  SYRINGE, PISTON 

OR 888.3020 INTRAMEDULLARY FIXATION ROD 

HSB  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES 

External Fixators (except devices with no external components): 

OR 888.3030 SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION 

APPLIANCES AND ACCESSORIES 

KTT  APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, 

MULTIPLE COMPONENT 

OR 888.3040 SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER 

HTY  PIN, FIXATION, SMOOTH 

JDW  PIN, FIXATION, THREADED 

CE/USA/Annex/en 124 
U.S. - EC MRA Medical Devices Annex 

Selected Dental Materials: 

DE 872.3060 GOLD BASED ALLOYS AND PRECIOUS METAL ALLOYS FOR 

CLINICAL USE 

EJT  ALLOY, GOLD BASED, FOR CLINICAL USE 

EJS  ALLOY, PRECIOUS METAL, FOR CLINICAL USE 

DE 872.3200 RESIN TOOTH BONDING AGENT 

KLE  AGENT, TOOTH BONDING, RESIN 

DE 872.3275 DENTAL CEMENT 

EMA  CEMENT, DENTAL 

EMB  ZINC OXIDE EUGENOL 

DE 872.3660 IMPRESSION MATERIAL 

ELW  MATERIAL, IMPRESSION 

DE 872.3690 TOOTH SHADE RESIN MATERIAL 

EBF  MATERIAL, TOOTH SHADE, RESIN 

DE 872.3710 BASE METAL ALLOY 

EJH  METAL, BASE 

Latex Condoms: 

OB 884.5300 CONDOM 

HIS  CONDOM 

TABLE 3 

MEDICAL DEVICES FOR POSSIBLE INCLUSION 

IN SCOPE OF PRODUCT COVERAGE 

CE/USA/Annex/en 125 
U.S. - EC MRA Medical Devices Annex 

DURING OPERATIONAL PERIOD 

Anaesthesiology Panel 

Product Family Section No Device Name Tier 

Anesthesia Devices 868.5160 Gas machine for anesthesia or analgesia 2 

868.5270 Breathing system heater 2 

868.5440 Portable oxygen generator 2 

868.5450 Respiratory gas humidifier 2 

868.5630 Nebulizer 2 

868.5710 Electrically powered oxygen tent 2 

868.5880 Anesthetic vaporizer 2 

Gas Analyzer 868.1040 Powered Algesimeter 2 

868.1075 Argon gas analyzer 2 

868.1400 Carbon dioxide gas analyzer 2 

868.1430 Carbon monoxide gas analyzer 2 

868.1500 Enflurane gas analyzer 2 

868.1620 Halothane gas analyzer 2 

868.1640 Helium gas analyzer 2 

868.1670 Neon gas analyzer 2 

868.1690 Nitrogen gas analyzer 2 

868.1700 Nitrous oxide gas analyzer 2 

868.1720 Oxygen gas analyzer 2 

868.1730 Oxygen uptake computer 2 

CE/USA/Annex/en 126 
U.S. - EC MRA Medical Devices Annex 

Peripheral Nerve 

Stimulators 

868.2775 Electrical peripheral nerve stimulator 2 

Respiratory 

Monitoring 

868.1750 Pressure plethysmograph 2 

868.1760 Volume plethysmograph 2 

868.1780 Inspiratory airway pressure meter 2 

868.1800 Rhinoanemometer 2 

868.1840 Diagnostic spirometer 2 

868.1850 Monitoring spirometer 2 

868.1860 Peak-flow meter for spirometry 2 

868.1880 Pulmonary-function data calculator 2 

868.1890 Predictive pulmonary-function value 

calculator 

2 

868.1900 Diagnostic pulmonary-function 

interpretation calculator 

2 

868.2025 Ultrasonic air embolism monitor 2 

868.2375 Breathing frequency monitor (except 

apnea detectors) 

2 

868.2480 Cutaneous carbon dioxide (PcCO )2

monitor 

2 

868.2500 Cutaneous oxygen monitor (for an infant 

not under gas anesthesia) 

2 

868.2550 Pneumotachomometer 2 

868.2600 Airway pressure monitor 2 

868.5665 Powered percussor 2 

868.5690 Incentive spirometer 2 

Ventilator 868.5905 Noncontinuous ventilator (IPPB) 2 

868.5925 Powered emergency ventilator 2 

868.5935 External negative pressure ventilator 2 

868.5895 Continuous ventilator 2 

868.5955 Intermittent mandatory ventilation 

attachment 

2 

868.6250 Portable air compressor 2 

CE/USA/Annex/en 127 
U.S. - EC MRA Medical Devices Annex 

Cardiovascular Panel 

Product Family Section No Device Name Tier 

Cardiovascular 

Diagnostic 

870.1425 Programmable diagnostic computer 2 

870.1450 Densitometer 2 

870.2310 Apex cardiograph (vibrocardiograph) 2 

870.2320 Ballistocardiograph 2 

870.2340 Electrocardiograph 2 

870.2350 Electrocardiograph lead switching 

adaptor 

1 

870.2360 Electrocardiograph electrode 2 

870.2370 Electrocardiograph surface electrode 

tester 

2 

870.2400 Vectorcardiograph 1 

870.2450 Medical cathode-ray tube display 1 

870.2675 Oscillometer 2 

870.2840 Apex cardiographic transducer 2 

870.2860 Heart sound transducer 2 

Cardiovascular 

Monitoring 

Valve, pressure relief, cardiopulmonary 

bypass 

870.1100 Blood pressure alarm 2 

870.1110 Blood pressure computer 2 

870.1120 Blood pressure cuff 2 

870.1130 Noninvasive blood pressure 

measurement system 

2 

870.1140 Venous blood pressure manometer 2 

870.1220 Electrode recording catheter or 

electrode recording probe 

2 

870.1270 Intracavitary phonocatheter system 2 

870.1875 Stethoscope (electronic) 2 

CE/USA/Annex/en 128 
U.S. - EC MRA Medical Devices Annex 

870.2050 Biopotential amplifier and signal 

conditioner 

2 

870.2060 Transducer signal amplifier and 

conditioner 

2 

870.2100 Cardiovascular blood flow-meter 2 

870.2120 Extravascular blood flow probe 2 

870.2300 Cardiac monitor (including 

cardiotachometer and rate alarm) 

2 

870.2700 Oximeter 2 

870.2710 Ear oximeter 2 

870.2750 Impedance phlebograph 2 

870.2770 Impedance plethysmograph 2 

870.2780 Hydraulic, pneumatic, or photoelectric 

plethysmographs 

2 

870.2850 Extravascular blood pressure transducer 2 

870.2870 Catheter tip pressure transducer 2 

870.2880 Ultrasonic transducer 2 

870.2890 Vessel occlusion transducer 2 

870.2900 Patient transducer and electrode cable 

(including connector) 

2 

870.2910 Radiofrequency physiological signal 

transmitter and receiver 

2 

870.2920 Telephone electrocardiograph 

transmitter and receiver 

2 

870.4205 Cardiopulmonary bypass bubble 

detector 

2 

870.4220 Cardiopulmonary bypass heart-lung 

machine console 

2 

870.4240 Cardiovascular bypass heat exchanger 2 

870.4250 Cardiopulmonary bypass temperature 

controller 

2 

870.4300 Cardiopulmonary bypass gas control unit 2 

870.4310 Cardiopulmonary bypass coronary 

pressure gauge 

2 

870.4330 Cardiopulmonary bypass on-line blood 

gas monitor 

2 

870.4340 Cardiopulmonary bypass level sensing 

monitor and/or control 

2 

CE/USA/Annex/en 129 
U.S. - EC MRA Medical Devices Annex 

870.4370 Roller-type cardiopulmonary bypass 

blood pump 

2 

870.4380 Cardiopulmonary bypass pump speed 

control 

2 

870.4410 Cardiopulmonary bypass in-line blood 

gas sensor 

2 

Cardiovascular 

Therapeutic 

870.5050 Patient care suction apparatus 2 

870.5900 Thermal regulation system 2 

Defibrillator 870.5300 DC-defibrillator (including paddles) 2 

870.5325 Defibrillator tester 2 

Echocardiograph 870.2330 Echocardiograph 2 

Pacemaker and 

Accessories 

870.1750 External programmable pacemaker 

pulse generator 

2 

870.3630 Pacemaker generator function analyzer 2 

870.3640 Indirect pacemaker generator function 

analyzer 

2 

870.3720 Pacemaker electrode function tester 2 

Miscellaneous 870.1800 Withdrawal-infusion pump 2 

870.2800 Medical magnetic tape recorder 2 

None Batteries, rechargeable, class II devices 

CE/USA/Annex/en 130 
U.S. - EC MRA Medical Devices Annex 

Dental Panel 

Product Family Section No Device Name Tier 

Dental Equipment 872.1720 Pulp tester 2 

872.1740 Caries detection device 2 

872.4120 Bone cutting instrument and accessories 2 

872.4465 Gas-powered jet injector 2 

872.4475 Spring-powered jet injector 2 

872.4600 Intraoral ligature and wire lock 2 

872.4840 Rotary scaler 2 

872.4850 Ultrasonic scaler 2 

872.4920 Dental electrosurgical unit and 

accessories 

2 

872.6070 Ultraviolet activator for polymerization 2 

872.6350 Ultraviolet detector 2 

Dental Material 872.3050 Amalgam alloy 2 

872.3060 Gold-based alloys and precious metal 

alloys for clinical use 

2 

872.3200 Resin tooth bonding agent 2 

872.3250 Calcium hydroxide cavity liner 2 

872.3260 Cavity varnish 2 

872.3275 Dental cement (other than zinc 

oxide-eugenol) 

2 

872.3300 Hydrophilic resin coating for dentures 2 

872.3310 Coating material for resin fillings 2 

872.3590 Preformed plastic denture tooth 2 

872.3660 Impression material 2 

872.3690 Tooth shade resin material 2 

872.3710 Base metal alloy 2 

CE/USA/Annex/en 131 
U.S. - EC MRA Medical Devices Annex 

872.3750 Bracket adhesive resin and tooth 

conditioner 

2 

872.3760 Denture relining, repairing, or rebasing 

resin 

2 

872.3765 Pit and fissure sealant and conditioner 2 

872.3770 Temporary crown and bridge resin 2 

872.3820 Root canal filling resin (other than 

chloroform use) 

2 

872.3920 Porcelain tooth 2 

Dental X-ray 872.1800 Extraoral source x-ray system 2 

872.1810 Intraoral source x-ray system 2 

Dental Implants 872.4880 Intraosseous fixation screw or wires 2 

872.3890 Endodontic stabilizing splint 2 

Orthodontic 872.5470 Orthodontic plastic bracket 2 

Ear/Nose/Throat Panel 

Product Family Section No Device Name Tier 

Diagnostic 

Equipment 

874.1050 Audiometer 2 

874.1090 Auditory impedance tester 2 

874.1120 Electronic noise generator for 

audiometric testing 

2 

874.1325 Electroglottograph 2 

874.1820 Surgical nerve stimulator/locator 2 

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U.S. - EC MRA Medical Devices Annex 

Hearing Aids 874.3300 Hearing aid (for bone-conduction) 2 

874.3310 Hearing aid calibrator and analysis 

system 

2 

874.3320 Group hearing aid or group auditory 

trainer 

2 

874.3330 Master hearing aid 2 

Surgical Equipment 874.4250 Ear, nose, and throat electric or 

pneumatic surgical drill 

1 

874.4490 Argon laser for otology, rhinology, and 

laryngology 

2 

874.4500 ENT microsurgical carbon dioxide laser 2 

Gastroenterology/Urology Panel 

Product Family Section No Device Name Tier 

Endoscope 

(including 

angioscopes, 

laparscopes, 

ophthalmic 

endoscopes) 

876.1500 Endoscope and accessories 2 

876.4300 Endoscopic electrosurgical unit and 

accessories 

2 

Gastroenterology 876.1725 Gastrointestinal motility monitoring system 1 

Hemodialysis 876.5600 Sorbent regenerated dialysate delivery 

system for hemodialysis 

2 

876.5630 Peritoneal dialysis system and accessories 2 

876.5665 Water purification system for hemodialysis 2 

876.5820 Hemodialysis system and accessories 2 

876.5830 Hemodialyzer with disposable insert 

(kiil-type) 

2 

CE/USA/Annex/en 133 
U.S. - EC MRA Medical Devices Annex 

Lithotriptor 876.4500 Mechanical lithotriptor 2 

Urology Equipment 876.1620 Urodynamics measurement system 2 

876.5320 Nonimplanted electrical continence 

device 

2 

876.5880 Isolated kidney perfusion and transport 

system and accessories 

2 

General Hospital Panel 

Product Family Section No Device Name Tier 

Infusion Pumps and 

Systems 

880.2420 Electronic monitor for gravity flow infusion 

systems 

2 

880.2460 Electrically powered spinal fluid pressure 

monitor 

2 

880.5430 Nonelectrically powered fluid injector 2 

880.5725 Infusion pump 2 

Neonatal Incubators 880.5400 Neonatal incubator 2 

880.5410 Neonatal transport incubator 2 

880.5700 Neonatal phototherapy unit 2 

Piston Syringes 880.5570 Hypodermic single lumen needle 1 

880.5860 Piston syringe (except anti-stick) 1 

880.6920 Syringe needle introducer 2 

Miscellaneous 880.2910 Clinical electronic thermometer 2 

880.2920 Clinical mercury thermometer 2 

880.5100 AC-powered adjustable hospital bed 1 

CE/USA/Annex/en 134 
U.S. - EC MRA Medical Devices Annex 

880.5500 AC-powered patient lift 2 

880.6880 Steam Sterilizer (greater than 2 cubic 

feet) 

2 

Neurology Panel 

Product Family Section No Device Name Tier 

882.1020 Rigidity analyzer 2 

882.1610 Alpha monitor 2 

Neuro-Diagnostic 882.1320 Cutaneous electrode 2 

882.1340 Nasopharyngeal electrode 2 

882.1350 Needle electrode 2 

882.1400 Electroencephalograph 2 

882.1460 Nystagmograph 2 

882.1480 Neurological endoscope 2 

882.1540 Galvanic skin response measurement 

device 

2 

882.1550 Nerve conduction velocity measurement 

device 

2 

882.1560 Skin potential measurement device 2 

882.1570 Powered direct-contact temperature 

measurement device 

2 

882.1620 Intracranial pressure monitoring device 2 

882.1835 Physiological signal amplifier 2 

882.1845 Physiological signal conditioner 2 

882.1855 Electroencephalogram (EEG) telemetry 

system 

2 

882.5050 Biofeedback device 2 

Echoencephalograp 

hy 

882.1240 Echoencephalograph 2 

CE/USA/Annex/en 135 
U.S. - EC MRA Medical Devices Annex 

RPG 882.4400 Radiofrequency lesion generator 2 

Neuro Surgery none Electrode, spinal epidural 2 

882.4305 Powered compound cranial drills, burrs, 

trephines and their accessories 

2 

882.4310 Powered simple cranial drills, burrs, 

trephines and accessories 

2 

882.4360 Electric cranial drill motor 2 

882.4370 Pneumatic cranial drill motor 2 

882.4560 Stereotaxic instrument 2 

882.4725 Radiofrequency lesion probe 2 

882.4845 Powered rongeur 2 

882.5500 Lesion temperature monitor 2 

Stimulators 882.1870 Evoked response electrical stimulator 2 

882.1880 Evoked response mechanical stimulator 2 

882.1890 Evoked response photic stimulator 2 

882.1900 Evoked response auditory stimulator 2 

882.1950 Tremor transducer 2 

882.5890 Transcutaneous electrical nerve 

stimulator for pain relief 

2 

CE/USA/Annex/en 136 
U.S. - EC MRA Medical Devices Annex 

Obstetrics/Gynaecology Panel 

Product Family Section No Device Name Tier 

Fetal Monitoring 884.1660 Transcervical endoscope (amnioscope) 

and accessories 

2 

884.1690 Hysteroscope and accessories (for 

performance standards) 

2 

884.2225 Obstetric-gynecologic ultrasonic imager 2 

884.2600 Fetal cardiac monitor 2 

884.2640 Fetal phonocardiographic monitor and 

accessories 

2 

884.2660 Fetal ultrasonic monitor and accessories 2 

884.2675 Fetal scalp circular (spiral) electrode and 

applicator 

1 

884.2700 Intrauterine pressure monitor and 

accessories 

2 

884.2720 External uterine contraction monitor and 

accessories 

2 

884.2740 Perinatal monitoring system and 

accessories 

2 

884.2960 Obstetric ultrasonic transducer and 

accessories 

2 

Gynecological 

Surgery Equip. 

884.1720 Gynecologic laparoscope and 

accessories 

2 

884.4160 Unipolar endoscopic coagulator-cutter 

and accessories 

2 

884.4550 Gynecologic surgical laser 2 

884.4120 Gynecologic electrocautery and 

accessories 

2 

884.5300 Condom 2 

CE/USA/Annex/en 137 
U.S. - EC MRA Medical Devices Annex 

Product Family Section No Device Name Tier 

Ophthalm. Implants 886.3320 Eye sphere implant 2 

Contact Lens 886.1385 Polymethylmethacrylate (PMMA) 

diagnostic contact lens 

2 

886.5916 Rigid gas permeable contact lens (daily 

wear only) 

2 

Diagnostic 

Equipment 

886.1120 Ophthalmic camera 1 

886.1220 Corneal electrode 1 

886.1250 Euthyscope (AC-powered) 1 

886.1360 Visual field laser instrument 1 

886.1510 Eye movement monitor 1 

886.1570 Ophthalmoscope 1 

886.1630 AC-powered photostimulator 1 

886.1640 Ophthalmic preamplifier 1 

886.1670 Ophthalmic isotope uptake probe 2 

886.1780 Retinoscope (AC-powered device) 1 

886.1850 AC-powered slitlamp biomicroscope 1 

886.1930 Tonometer and accessories 2 

886.1945 Transilluminator (AC-powered device) 1 

886.3130 Ophthalmic conformer 2 

(Diagnostic/Surgery 

Equipment) 

886.4670 Phacofragmentation System 2 

Ophthalm. Implants 886.3340 Extraocular orbital implant 2 

886.3800 Scleral shell 2 

CE/USA/Annex/en 138 
U.S. - EC MRA Medical Devices Annex 

Surgical Equipment 880.5725 Infusion pump (performance standards) 2 

886.3100 Ophthalmic tantalum clip 2 

886.3300 Absorbable implant (scleral buckling 

method) 

2 

886.4100 Radiofrequency electrosurgical cautery 

apparatus 

2 

886.4115 Thermal cautery unit 2 

886.4150 Vitreous aspiration and cutting instrument 2 

886.4170 Cryophthalmic unit 2 

886.4250 Ophthalmic electrolysis unit 

(AC-powered device) 

1 

886.4335 Operating headlamp (AC-powered 

device) 

1 

886.4390 Ophthalmic laser 2 

886.4392 Nd:YAG laser for posterior capsulotomy 2 

886.4400 Electronic metal locator 1 

886.4440 AC-powered magnet 1 

886.4610 Ocular pressure applicator 2 

886.4690 Ophthalmic photocoagulator 2 

886.4790 Ophthalmic sponge 2 

886.5100 Ophthalmic beta radiation source 2 

none Ophthalmoscopes, replacement 

batteries, hand-held 

1 

CE/USA/Annex/en 139 
U.S. - EC MRA Medical Devices Annex 

Orthopedic Panel 

Product Family Section No Device Name Tier 

Implants 888.3010 Bone fixation cerclage 2 

888.3020 Intramedullary fixation rod 2 

888.3030 Single/multiple component metallic bone 

fixation appliances and accessories 

2 

888.3040 Smooth or threaded metallic bone 

fixation fastener 

2 

888.3050 Spinal interlaminal fixation orthosis 2 

888.3060 Spinal intervertebral body fixation orthosis 2 

Surgical Equipment 888.1240 AC-powered dynamometer 2 

888.4580 Sonic surgical instrument and 

accessories/attachments 

2 

none Accessories, fixation, spinal interlaminal 2 

none Accessories, fixation, spinal intervertebral 

body 

2 

none Monitor, pressure, intracompartmental 1 

none Orthosis, fixation, spinal intervertebral 

fusion 

2 

none Orthosis, spinal pedicle fixation 

none System, cement removal extraction 1 

Physical Medicine Panel 

Product Family Section No Device Name Tier 

Diagnostic 

Equipment 

890.1225 Chronaximeter 2 

890.1375 Diagnostic electromyograph 2 

890.1385 Diagnostic electromyograph needle 

electrode 

2 

890.1450 Powered reflex hammer 2 

890.1850 Diagnostic muscle stimulator 2 

or (Therapy) 890.5850 Powered muscle stimulator 2 

CE/USA/Annex/en 140 
U.S. - EC MRA Medical Devices Annex 

Therapeutic 

Equipment 

890.5100 Immersion hydrobath 2 

890.5110 Paraffin bath 2 

890.5500 Infrared lamp 2 

890.5720 Water circulating hot or cold pack 2 

890.5740 Powered heating pad 2 

Radiology Panel 

Product Family Section No Device Name Tier 

MRI 892.1000 Magnetic resonance diagnostic device 2 

Ultrasound 

Diagnostic 

884.2660 Fetal ultrasonic monitor and accessories 2 

892.1540 Nonfetal ultrasonic monitor 

892.1560 Ultrasonic pulsed echo imaging system 2 

892.1570 Diagnostic ultrasonic transducer 2 

892.1550 Ultrasonic pulsed doppler imaging system 

Angiographic 892.1600 Angiographic x-ray system 2 

Diagnostic X-Ray 892.1610 Diagnostic x-ray beam-limiting device 2 

892.1620 Cine or spot fluorographic x-ray Camera 2 

892.1630 Electrostatic x-ray imaging system 2 

892.1650 Image-intensified fluoroscopic x-ray 

system 

2 

892.1670 Spot film device 2 

892.1680 Stationary x-ray system 2 

892.1710 Mammographic x-ray system 2 

892.1720 Mobile x-ray system 2 

892.1740 Tomographic x-ray system 1 

892.1820 Pneumoencephalographic chair 2 

892.1850 Radiographic film cassette 1 

892.1860 Radiographic film/cassette changer 1 

892.1870 Radiographic film/cassette changer 

programmer 

2 

892.1900 Automatic radiographic film processor 2 

892.1980 Radiologic table 1 

CE/USA/Annex/en 141 
U.S. - EC MRA Medical Devices Annex 

CT Scanner 892.1750 Computed tomography x-ray system 2 

Radiation Therapy 892.5050 Medical charged-particle radiation 

therapy system 

2 

892.5300 Medical neutron radiation therapy 

system 

2 

892.5700 Remote controlled 

radionuclide-applicator system 

2 

892.5710 Radiation therapy beam-shaping block 2 

892.5730 Radionuclide brachytherapy source 2 

892.5750 Radionuclide radiation therapy system 2 

892.5770 Powered radiation therapy patient 

support assembly 

2 

892.5840 Radiation therapy simulation system 2 

892.5930 Therapeutic x-ray tube housing assembly 1 

Nuclear Medicine 892.1170 Bone densitometer 2 

892.1200 Emission computed tomography system 2 

892.1310 Nuclear tomography system 1 

892.1390 Radionuclide rebreathing system 2 

General/Plastic Surgery Panel 

Product Family Section No Device Name Tier 

Surgical Lamps 878.4630 Ultraviolet lamp for dermatologic 

disorders 

2 

890.5500 Infrared lamp 2 

878.4580 Surgical lamp 2 

Electrosurgical 

Cutting Equipment 

878.4810 Laser surgical instrument for use in 

general and plastic surgery and in 

dermatology 

2 

878.4400 Electrosurgical cutting and coagulation 

device and accessories 

2 

Miscellaneous 878.4780 Powered suction pump 2 

CE/USA/Annex/en 142 
U.S. - EC MRA Medical Devices Annex 

APPENDIX 3 

AUTHORITIES RESPONSIBLE FOR DESIGNATING 

CONFORMITY ASSESSMENT BODIES 

EC access to the U.S. market U.S. access to the EC market 

 Belgium 

Ministère de la Santé publique, de 

l'Environnement et de l'Intégration sociale 

Ministerie van Volksgezondheid, Leefmilieu 

en Sociale Integratie 

 Denmark 

Sundhedsministeriet 

 Germany 

Bundesministerium für Gesundheit 

 Greece 

=ΞΩ]ΨΚΜΓΩ =ΚΜΓΙΖ 

Ministry of Health 

 Spain 

Ministerio de Sanidad y Consumo 

 France 

Ministère de l'emploi et de la solidarité 

Ministère de l’économie, des finances et de 

l’industrie 

 Ireland 

Department of Health 

 Italy 

Ministero della Sanità 

 Luxembourg 

Ministère de la Santé 

 Netherlands 

Staat des Nederlanden 

 Austria 

Bundesministerium für Arbeit, 

Gesundheit und Soziales 

 Portugal 

Ministerio da Saude 

 Finland 

Sosiaali-ja terveysministeriö/social-och 

hälsovårdsministeriet 

 Sweden 

Under the authority of the Government of 

Sweden: 

Styrelsen för ackreditering och teknisk kontroll 

(SWEDAC) 

 United Kingdom 

Food and Drug Administration (FDA) 

CE/USA/Annex/en 143 
U.S. - EC MRA Medical Devices Annex 

Department of Health 

CE/USA/Annex/en 144 
U.S. - EC MRA Medical Devices Annex 

APPENDIX 4 

CONFORMITY ASSESSMENT BODIES 

EC access to the U.S. market U.S. access to the EC market 

Conformity assessment bodies located in 

the EC shall be designated by the 

Authorities identified in Appendix 3. 

(to be provided by the EC) 

Conformity assessment bodies located in 

the U.S. shall be designated by the 

Authorities identified in Appendix 3. 

(to be provided by the U.S.) 

CE/USA/Annex/en 145