Source: https://eur-lex.europa.eu/legal-content/SL/ALL/?uri=CELEX:21999A0204(01)
Timestamp: 2018-08-18 03:42:45
Document Index: 459946271

Matched Legal Cases: ['art 68', 'art 68', 'art 74', 'art 80', 'art 80', 'art 95', 'art 97', 'art 18', 'art 15', 'arts 1', 'arts 200', 'arts 500', 'arts 600', '§ 321', '§ 201', 'arts 800']

EUR-Lex - 21999A0204(01) - EN - EUR-Lex
EUR-Lex - 21999A0204(01) - EN
Document 21999A0204(01)
Sporazum o vzajemnem priznavanju med Evropsko skupnostjo in Združenimi državami Amerike
OJ L 31, 4.2.1999, p. 3–80 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 11 Volume 030 P. 181 - 258
Special edition in Estonian: Chapter 11 Volume 030 P. 181 - 258
Special edition in Latvian: Chapter 11 Volume 030 P. 181 - 258
Special edition in Lithuanian: Chapter 11 Volume 030 P. 181 - 258
Special edition in Hungarian Chapter 11 Volume 030 P. 181 - 258
Special edition in Maltese: Chapter 11 Volume 030 P. 181 - 258
Special edition in Polish: Chapter 11 Volume 030 P. 181 - 258
Special edition in Slovak: Chapter 11 Volume 030 P. 181 - 258
Special edition in Slovene: Chapter 11 Volume 030 P. 181 - 258
Special edition in Bulgarian: Chapter 11 Volume 019 P. 3 - 80
Special edition in Romanian: Chapter 11 Volume 019 P. 3 - 80
Special edition in Croatian: Chapter 11 Volume 105 P. 49 - 126
Language 1 Bulgarian (bg) Spanish (es) Czech (cs) Danish (da) German (de) Estonian (et) Greek (el) English (en) French (fr) Croatian (hr) Italian (it) Latvian (lv) Lithuanian (lt) Hungarian (hu) Maltese (mt) Dutch (nl) Polish (pl) Portuguese (pt) Romanian (ro) Slovak (sk) Finnish (fi) Swedish (sv) Language 2 Please choose Bulgarian (bg) Spanish (es) Czech (cs) Danish (da) German (de) Estonian (et) Greek (el) English (en) French (fr) Croatian (hr) Italian (it) Latvian (lv) Lithuanian (lt) Hungarian (hu) Maltese (mt) Dutch (nl) Polish (pl) Portuguese (pt) Romanian (ro) Slovak (sk) Finnish (fi) Swedish (sv) Language 3 Please choose Bulgarian (bg) Spanish (es) Czech (cs) Danish (da) German (de) Estonian (et) Greek (el) English (en) French (fr) Croatian (hr) Italian (it) Latvian (lv) Lithuanian (lt) Hungarian (hu) Maltese (mt) Dutch (nl) Polish (pl) Portuguese (pt) Romanian (ro) Slovak (sk) Finnish (fi) Swedish (sv)
Date of document: 18/05/1998
Date of effect: 01/12/1998; začetek veljavnosti glej člen 21 in UL L 31/99 P. 81
Date of signature: 18/05/1998; London
Author: Evropska skupnost, Združene države
INDEX.CM: posvetovanja, dvostranski sporazum, Skupni odbor, zaščitna klavzula
11992E228 - P3L1 ADOPTION
11992E228 - P4 ADOPTION
Adopted by 31999D0078 DP22/6/98
Amended by 22001D0123(01) sprememba priloga 12/12/2000
Amended by 22001D0203(02) sprememba priloga 04/12/2000
Amended by 22001D0813 dopolnitev priloga 16/01/2001
Amended by 22001D0814 dopolnitev priloga 21/05/2001
Amended by 22001D0815 dopolnitev priloga 26/06/2001
Amended by 22001D0816 dopolnitev priloga 17/07/2001
Amended by 22001D0817 dopolnitev priloga 20/07/2001
Amended by 22002D0288 dopolnitev priloga 05/10/2001
Amended by 22002D0289 sprememba priloga 21/11/2001
Amended by 22002D0290 dopolnitev priloga 20/11/2001
Amended by 22002D0291 dopolnitev priloga 30/11/2001
Amended by 22002D0292 dopolnitev priloga 15/01/2002
Amended by 22002D0293 dopolnitev priloga 12/02/2002
Amended by 22002D0295 dopolnitev priloga 22/03/2002
Amended by 22002D0872 sprememba priloga 16/04/2002
Amended by 22002D0873 dopolnitev priloga 06/05/2002
Amended by 22002D0874 dopolnitev priloga 25/07/2002
Amended by 22002D0875 dopolnitev priloga 28/08/2002
Amended by 22002D0876 dopolnitev priloga 20/09/2002
Amended by 22003D0108 sprememba priloga 20/11/2002
Amended by 22003D0109 sprememba priloga 22/01/2003
Amended by 22003D0110 sprememba priloga 05/02/2003
Amended by 22003D0648 dopolnitev priloga 03/09/2003
Amended by 22003D0649 sprememba priloga 03/09/2003
Amended by 22004D0702 dopolnitev priloga 19/07/2004
Amended by 22004D0868 dopolnitev priloga 05/11/2004
Amended by 22006D0182 dopolnitev priloga 16/02/2006
Amended by 22011D0763 sprememba priloga SECTION V
Amended by 22014D0474 dopolnitev priloga SECTION V 07/08/2014
Amended by 22015D1354 dopolnitev priloga SECTION V 15/07/2015
Amended by 22017D0382 zamenjava priloga 01/03/2017
Amended by 22017D0465 dodatek priloga SECTION V besedilo 01/03/2017
Amended by 22017D0466 dodatek priloga SECTION V besedilo 01/03/2017
Amended by 22017D0467 dodatek priloga SECTION V besedilo 01/03/2017
Amended by 22017D0690 dodatek priloga SECTION V besedilo 27/03/2017
Amended by 22017D0691 dodatek priloga SECTION V besedilo 27/03/2017
Amended by 22017D0692 dodatek priloga SECTION V besedilo 27/03/2017
Amended by 22017D1574 dodatek priloga SECTION V besedilo 04/09/2017
Amended by 22017D2290 dodatek priloga SECTION V besedilo 24/11/2017
Amended by 22017D2291 dodatek priloga SECTION V besedilo 24/11/2017
Amended by 22017D2292 dodatek priloga SECTION V besedilo 24/11/2017
Amended by 22018D1051 dodatek priloga SECTION V besedilo 05/06/2018
Amended by 22018D1052 dodatek priloga SECTION V besedilo 05/06/2018
Amended by 22018D1053 dodatek priloga SECTION V besedilo 05/06/2018
Amended by 22018D1054 dodatek priloga SECTION V besedilo 05/06/2018
Amended by 22018D1055 dodatek priloga SECTION V besedilo 05/06/2018
Amended by 22018D1056 dodatek priloga SECTION V besedilo 05/06/2018
Amended by 22018D1057 dodatek priloga SECTION V besedilo 05/06/2018
Amended by 22018D1058 dodatek priloga SECTION V besedilo 05/06/2018
21994A1223(07)
22002D0294
on mutual recognition between the European Community and the United States of America
Telecommunication Equipment 13
Electromagnetic Compatibility (EMC) 21
Electical Safety 27
Recreational Craft 32
Pharmaceutical Good Manufacturing Practices (GMPs) 36
Medical Devices 49
The EUROPEAN COMMUNITY, and 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 (US) and the European Community (EC);
DESIRING to facilitate bilateral trade between them;
RECOGNISING that mutual recognition of conformity assessment activities is an important means of enhancing market access between the Parties;
RECOGNISING that an agreement providing for mutual recognition of conformity assessment activities is of particular interest to small and medium-sized businesses in the US and the EC;
RECOGNISING that any such mutual recognition also requires confidence in the continued reliability of the other Party's conformity assessments;
RECOGNISING the importance of maintaining each Party's high levels of health, safety, environmental and consumer protection;
RECOGNISING that mutual recognition agreements can positively contribute in encouraging greater international harmonisation of standards;
NOTING that this Agreement is not intended to displace private sector bilateral and multilateral arrangements among conformity assessment bodies or to affect regulatory regimes allowing for manufacturers' self-assessments and declarations of conformity;
BEARING IN MIND that the Agreement on Technical Barriers to Trade, an agreement annexed to the Agreement establishing the World Trade Organization (WTO), imposes obligations on the Parties as Contracting Parties to the WTO, and encourages such Contracting Parties to enter into negotiations for the conclusion of agreements for the mutual recognition of results of each other's conformity assessment;
RECOGNISING 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;
RECOGNISING 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.
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 Standardisation (ISO) and the International Electrotechnical Commission (IEC). In the event of an inconsistency between ISO/IEC Guide 2 and definitions in this Agreement, the definitions in this Agreement shall prevail.
This Agreement specifies the conditions by which each Party will accept or recognise results of conformity assessment procedures, produced by the other Party's conformity assessment bodies or authorities, in assessing conformity to the importing Party's requirements, as specified on a sector-specific basis in the Sectoral Annexes, and to provide for other related cooperative activities. The objective of such mutual recognition is to provide effective market access throughout the territories of the Parties with regard to conformity assessment for all products covered under this Agreement. If any obstacles to such access arise, consultations will promptly be held. In the absence of a satisfactory outcome of such consultations, the Party alleging its market access has been denied, may, within 90 days of such consultation, invoke its right to terminate the Agreement in accordance with Article 21.
1. The United States shall, as specified in the Sectoral Annexes, accept or recognise results of specified procedures, used in assessing conformity to specified legislative, regulatory, and administrative provisions of the United States, produced by the other Party's conformity assessment bodies and/or authorities.
2. The European Community and its Member States shall, as specified in the Sectoral Annexes, accept or recognise 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 utilised 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.
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 description of the relevant legislative, regulatory and administrative provisions pertaining to the conformity assessment procedures and technical regulations;
a statement on the product scope and coverage;
a list of Designating Authorities;
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;
the procedures and criteria for designating the conformity assessment bodies;
a description of the mutual recognition obligations;
a sectoral transition arrangement;
the identity of a sectoral contact point in each Party's territory; and
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 regulation 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.
The Parties agree to implement the transitional commitments on confidence building as specified in the Sectoral Annexes.
The Parties agree that each sectoral transition arrangement shall specify a time period for completion.
The Parties may amend any transition arrangement by mutual agreement.
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.
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.
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:
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;
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;
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
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.
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 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;
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;
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;
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;
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;
Upon the suspension of a conformity assessment body listed in a Sectoral Annex, a Party is no longer obligated to accept or recognise 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
The suspension shall remain in effect until agreement has been reached by the Parties upon the future status of that body.
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 Party proposing to withdraw a conformity assessment body listed in a Sectoral Annex shall forward its proposal in writing to the other Party;
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;
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;
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
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.
Monitoring of conformity assessment bodies
The following shall apply with regard to the monitoring of conformity assessment bodies listed in a Sectoral Annex:
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;
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;
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;
Each Party recognises that the conformity assessment bodies listed in the Sectoral Annexes fulfil the conditions of eligibility to assess conformity in relation to its requirements as specified in the Sectoral Annexes. The Parties shall specify the scope of the conformity assessment procedures for which such bodies are listed.
1. The Parties shall exchange information concerning the implementation of the legislative, regulatory, and administrative provisions identified in the Sectoral Annexes.
2. Each Party shall notify the other Party of legislative, regulatory and administrative changes related to the subject matter of this Agreement at least 60 days before their entry into force. Where considerations of safety, health or environmental protection require more urgent action a Party shall notify the other Party as soon as practicable.
3. Each Party shall promptly notify the other Party of any changes to its Designating Authorities and/or conformity assessment bodies.
4. The Parties shall exchange information concerning the procedures used to ensure that the listed conformity assessment bodies under their responsibility comply with the legislative, regulatory, and administrative provisions outlined in the Sectoral Annexes.
5. Regulatory Authorities identified in the Sectoral Annexes shall consult as necessary with their counterparts, to ensure the maintenance of confidence in conformity assessment procedures and to ensure that all technical requirements are identified and are satisfactorily addressed.
Sectoral contact points
Each Party shall appoint and confirm in writing contact points to be responsible for activities under each Sectoral Annex.
Joint Committee of the Parties
1. The Parties hereby establish a Joint Committee consisting of representatives of each Party. The Joint Committee comprised 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:
listing, suspension, withdrawal and verification of conformity assessment bodies in accordance with this Agreement;
amending transitional arrangements in Sectoral Annexes;
resolving any questions relating to the application of this Agreement and its Sectoral Annexes not otherwise resolved in the respective Joint Sectoral Committees;
providing a forum for discussion of issues that may arise concerning the implementation of this Agreement;
considering ways to enhance the operation of this Agreement;
coordinating the negotiation of additional Sectoral Annexes; and
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.
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 15 days of taking such action, providing its reasons.
Suspension of recognition obligations
Either Party may suspend its obligations under a Sectoral Annex, in whole or in part, if:
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;
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;
the other Party fails to maintain legal and regulatory authorities capable of implementing the provisions of this Agreement.
1. Each Party agrees to maintain, to the extent required under its laws, the confidentiality of information exchanged under this Agreement.
2. In particular, neither Party shall disclose to the public, nor permit a conformity assessment body to disclose to the public, information exchanged under this Agreement that constitutes trade secrets, confidential commercial or financial information, or information that relates to an ongoing investigation.
3. A Party or a conformity assessment body may, upon exchanging information with the other Party or with a conformity assessment body of the other Party, designate the portions of the information that it considers to be exempt from disclosure.
4. Each Party shall take all precautions reasonably necessary to protect information exchanged under this Agreement from unauthorised disclosure.
Each Party shall endeavour to ensure that fees imposed for services under this Agreement shall be commensurate with the services provided. Each Party shall ensure that, for the sectors and conformity assessment procedures covered under this Agreement, it shall charge no fees with respect to conformity assessment services provided by the other Party.
Except where there is written agreement between the Parties, obligations contained in mutual recognition agreements concluded by either Party with a party not a signatory to this Agreement (a third party) shall have no force and effect with regard to the other Party in terms of acceptance of the results of conformity assessment procedures in the third party.
This Agreement shall apply, on the one hand, to the territories in which the Treaty establishing the European Community is applied, and under the conditions laid down in that Treaty and, on the other hand, to the territory of the United States.
1. This Agreement including its Sectoral Annexes on Telecommunication Equipment, Electromagnetic Compatibility, Electrical Safety, Recreational Craft, Pharmaceutical Good Manufacturing Practices (GMPs), and Medical Devices shall enter into force on the first day of the second month following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of this Agreement.
2. This Agreement including any Sectoral Annex may, through the Joint Committee, be amended in writing by the Parties. The Parties may add a Sectoral Annex upon the exchange of letters. Such Annex shall enter into force 30 days following the date on which the Parties have exchanged letters confirming the completion of their respective procedures for the entry into force of the Sectoral Annex.
3. Either Party may terminate this Agreement in its entirety or any individual Sectoral Annex thereof by giving the other Party six months notice in writing. In the case of termination of one or more Sectoral Annexes, the Parties will seek to achieve by consensus to amend this Agreement, with a view to preserving the remaining Sectoral Annexes, in accordance with the procedures in this Article. Failing such consensus, the Agreement shall terminate at the end of six months 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.
1. The Sectoral Annexes referred to in Article 21(1), as well as any New Sectoral Annexes added pursuant to Article 21(2), shall form an integral part of this Agreement.
2. For a given product or sector, the provisions contained in the relevant Sectoral Annexes shall apply in the first place, and the provisions of this text in addition to those provisions. In the case of any inconsistency between the provisions of a Sectoral Annex and this text, the Sectoral Annex shall prevail, to the extent of that inconsistency.
3. This Agreement shall not affect the rights and obligations of the Parties under any other international agreement.
4. In the case of the Sectoral Annex on Medical Devices, the Parties shall review the status of such Annex at the end of three years from entry into force.
This Agreement and the Sectoral Annexes are drawn up in two original 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.
Hecho en Londres, el dieciocho de mayo de mil novecientos noventa y ocho.
Udfærdiget i London den attende maj nitten hundrede og otteoghalvfems.
Geschehen zu London am achtzehnten Mai neunzehnhundertachtundneunzig.
Έγινε στο Λονδίνο, στις δέκα οκτώ Μαΐου χίλια εννιακόσια ενενήντα οκτώ.
Done at London on the eighteenth day of May in the year one thousand nine hundred and ninety-eight.
Fait à Londres, le dix-huit mai mil neuf cent quatre-vingt-dix-huit.
Fatto a Londra, addì diciotto maggio millenovecentonovantotto.
Gedaan te Londen, de achttiende mei negentienhonderd achtennegentig.
Feito em Londres, em dezoito de Maio de mil novecentos e noventa e oito.
Tehty Lontoossa kahdeksantenatoista päivänä toukokuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäkahdeksan.
Som skedde i London den artonde maj nittonhundranittioåtta.
SECTORAL ANNEX FOR TELECOMMUNICATION EQUIPMENT
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition of Conformity Assessment between the United States and the European Community.
LEGISLATIVE, REGULATORY AND ADMINISTRATIVE PROVISIONS
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;
Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code).
The US regulatory and administrative provisions in respect of telecommunication equipment, including 47 CFR Part 68, and FCC interpretation thereof;
(The Parties recognize that the Handbook on the implementation of Directive 98/13/EC (ADLNB and ACTE approved), provides useful guidelines for the implementation of conformity assessment procedures falling under this Directive.);
(The 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.);
Commission Decisions (CTRs) established under Directive 98/13/EC;
The EC Member States' legislation and regulations in respect of:
non-harmonised analogue connection to the public telecommunications network (1);
non-harmonised radio transmitters for which there is a civilian equipment authorisation requirement;
The US regulatory and administrative provisions in respect of all radio transmitters subject to an equipment authorisation 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.
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:
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;
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
all radio transmitters subject to an equipment authorisation procedure by either Party.
The following is a non-exclusive list of the equipment, interfaces, and services included within the scope of this Sectoral Annex:
The following equipment categories are included:
ISDN Basic Rate Access
X21/V.24/V.35 Access
X25 Access
PSTN Non-Voice
PSTN Voice Band (Analog)
ONP Leased Line Terminal types:
4 Mbits/s access
140 Mbits/s access
2 wire analogue
4 wire analogue
Equipment categories covered under 47 CFR, Part 68, including:
ISDN Basic Access
Digital Service Access:
3.2 kbps (2.4 kbps with Secondary Channel)
6.4 kbps (4.8 kbps with SC)
12.8 kbps (9.6 kbps with SC)
25.0 kbps (19.2 kbps with SC)
64.0 kbps (uses 72 kbps channel)
72.0 kbps (56.0 kbps with SC)
2-wire 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 authorisation requirement, including:
Short range devices, including low power devices such as cordless telephones/microphones;
Land mobile, including:
Private Mobile Radio (PMR/PAMR)
Radio determination
Commercial Mobile Radio
Domestic Public Fixed
Auxiliary Broadcast
(Part 74)
(Part 80)
(Part 80W)
Private-Fixed Microwave
(Part 95 F)
(Part 97)
Fixed Microwave Services
Note: A list of acronyms and a glossary is contained in Appendix I to this Sectoral Annex.
CONFORMITY ASSESSMENT PROCEDURES FOR TELECOMMUNICATION EQUIPMENT
1. Description of Mutual Recognition Obligations
In accordance with the provisions of the Agreement, the result of the conformity assessment procedures produced by a Party's conformity assessment bodies listed in Section V shall be recognised 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 recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised to perform the following procedures with regard to the importing Party's technical requirements for telecommunication terminal, satellite terminal equipment, radio transmitters or information technology equipment:
testing and issuing of test reports;
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
performing quality assurance certification pursuant to Directive 98/13/EC.
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
Yπoυρyείo Mεταφoρών χaι Eπιχoιvωvιών
Ministero delle Communicazioni — DGROS e ISETI (Radiotransmettitori)
Instituto das Communicações de Portugal
Liikenneministeriö/Trafikministeriet Telehallintokeskus/Teleförvaltningscentralen
Under the authority of the Government of Sweden: Styrelsen för ackreditering och teknisk kontroll (SWEDAC)
EC access to the US market
US 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.
Conformity assessment bodies located in the US 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)
(to be provided by the US)
DESIGNATING, LISTING, SUSPENDING, WITHDRAWING AND MONITORING CONFORMITY ASSESSMENT BODIES LISTED IN SECTION V
EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US 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.
US Authorities identified in Section IV shall designate conformity assessment bodies located in the US 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. 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.
1. Sub-contracting
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.
The conformity assessment bodies shall record and retain details of their investigation of the competence and compliance of their subcontractors and maintain a register of all sub-contracting. These details will be available to the other Party on request.
2. Post-market surveillance, border measures and internal movement
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.
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.
The Parties agree that border inspections and checks of products which have been certified, labelled or marked as conforming with the importing Party's requirements specified in Section I shall be completed as expeditiously as possible. With regard to any inspections related to internal movement within their respective territories, the Parties agree that these shall be completed in no less a favourable manner than for like domestic goods.
3. Joint Sectoral Committee
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.
The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US 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 US or EC representative may raise the matter in the Joint Committee.
The JSC may address any matter related to the effective functioning of this Sectoral Annex, including:
providing a forum for discussion of issues and resolving problems that may arise concerning the implementation of this Sectoral Annex;
developing a mechanism for ensuring consistency of interpretations of legislation, regulations, standards, and conformity assessment procedures;
advising the Parties on matters relating to this Sectoral Annex; and
providing guidance and, if necessary, developing guidelines during the transitional period to facilitate the successful completion of the transitional period.
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.
There shall be a transitional period of 24 months.
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.
This transitional period shall be used by the Parties:
to consider new legislative changes needed to support the objectives of the Agreement;
to initiate regulatory changes needed to support the objectives of the Agreement;
to exchange information on and develop better understanding of their respective regulatory requirements;
to develop mutually agreed mechanisms for exchanging information on changes in technical requirements or methods of designating conformity assessment bodies; and
to monitor and evaluate the performance of the listed conformity assessment bodies during the transitional period.
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.
During the transitional period each Party shall accept and evaluate test reports and related documents issued by designated conformity assessment bodies of the other Party. To this end, the Parties shall ensure that:
on receipt of tests reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;
the applicant is informed in a precise and complete manner of any deficiency;
any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards; and
procedures for assessing the conformity for equipment, modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance.
Each Party ensures that issuance of approvals, certificates, or advice to the 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.
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.
The Parties may jointly sponsor two seminars, one in the US 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.
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.
(1) The EC agrees to seek authority to include non-harmonised digital connections;
Lists of acronyms and glossary
Association of Designated Laboratories and Notified Bodies
U.S. Code of Federal Regulations, Title 47 CFR
Norme Européenne (European Standard)
Member States (of the European Union)
Official Journal (of the European Union)
Sectoral Technical Group for Telecommunications
ITU-T Recommendation X21
ITU-T Recommendation X25
SECTORAL ANNEX FOR ELECTROMAGNETIC COMPATIBILITY (EMC)
Council Directive 89/336/EEC, as amended by Council Directive 92/3 I/EEC, and Directive 98/13/EC of the European Parliament and of the Council and interpretation thereof.
Communications Act of 1934, as amended by the Telecommunication Act of 1996, (Title 47 of the United States Code),
The US regulatory and administrative provisions in respect of equipment subject to electromagnetic requirements including:
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.
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.
CONFORMITY ASSESSMENT PROCEDURES FOR EQUIPMENT IDENTIFIED IN SECTION II
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 recognised by the Regulatory Authorities of the other Party without any further conformity assessment of the products, pursuant to Section I.
Taking into account the legislative, regulatory, and administrative provisions as identified in Section I, each Party recognises that the conformity assessment bodies of the other Party, listed in Section V, are authorised to perform the following procedures with regard to the importing Party's technical requirements for equipment identified in Section II:
testing and issuing of the test reports,
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.
for telecommunication equipment:
(DEMKO)
Instituto das Comunicações de Portugal
Kauppa- ja teollisuusministeriö/Handels- och industriministeriet
Under the authority of the Government of Sweden:
EC Authorities identified in Section IV shall designate conformity assessment bodies located in the EC in accordance with the US 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.
US Authorities identified in Section IV shall designate conformity assessment bodies located in the US 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.
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 Directive 93/465/EEC.
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.
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.
The Parties agree that border inspections and checks of products which have been certified, labeled or marked as conformity 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.
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.
The JSC consists of representatives of the US and the EC for telecommunications and EMC. JSC representatives may each invite manufacturers and other entities as deemed necessary. The representatives for the US shall 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 US or EC representatives may raise the matter in the Joint Committee.
advising the Parties on matters relating to this Sectoral Annex;
Each Party shall establish a contact point to provide answers to all reasonable inquiries from the other Party regarding procedures, regulations and complaints under this Sectoral Annex.
In the event that there are changes to the legislative, regulatory and administrative provisions referenced in Section I or the introduction of new legislative, regulatory and administrative provisions affecting either Party's conformity assessment procedures under the Agreement, such changes shall take effect for the purpose of this Sectoral Annex at the same time they take effect domestically within the territory of each Party. The Parties shall update this Sectoral Annex to reflect the changes.
There shall a transitional period of 24 months.
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.
on receipt of test reports, related documents and a first evaluation of conformity, the dossiers are promptly examined for completeness;
any request for additional information is limited to omissions, inconsistencies or variances from the technical regulations or standards;
procedures for assessing the conformity for equipment modified subsequent to a determination of compliance, are limited to procedures necessary to determine continued conformance.
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.
SECTORAL ANNEXFOR ELECTRICAL SAFETY
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition between the United States and the European Community.
Council Directive 73/23/EEC of 19 February 1973 as amended by Directive 98/13/EC of the European Parliament and of the Council.
29 USC 651 et seq. US 29 CFR 1910.7
Products that are certified or approved under the Federal Mine Safety and Health Act (30 USC 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 Medical Devices Sectoral Annex to this Agreement.
For electromagnetic compatibility aspects, see the Electromagnetic Compatibility (EMC) Sectoral Annex to this Agreement.
For telecommunication equipment, see the Telecommunication Equipment Sectoral Annex to this Agreement.
The electrical safety requirements of products falling under the scope of Council Directive 73/23/EEC on the harmonisation of the laws of the Member States relating to electrical equipment designed or 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.
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 recognised to test, certify and mark products within the scope of their Nationally Recognised Testing Laboratory (NRTL) recognition for assessing conformity to US requirements.
With regard to US 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 US shall be recognised under Article 11 of Council Directive 73/23/EEC as ‘bodies which may make a report in accordance with Article 8.’
Bygge- og Boligstyrelsen
Υπουργείο Ανάπτυξης Ministry of Development
Under the authority of the Government of Portugal:
The names and scope of responsibilities of Conformity Assessment Bodies located in the EC and listed in accordance with this Sectoral Annex:
The names and scope of responsibilities of Conformity Assessment Bodies located in the US and listed in accordance with this Sectoral Annex:
(to the provided by the EC)
(to be provided by the U.S.)
DESIGNATING, LISTING, SUSPENDING AND WITHDRAWING CONFORMITY ASSESSMENT BODIES
Conformity assessment bodies from the EC shall be designated by the EC Authorities identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and this Annex.
Conformity assessment bodies from the US shall be designated by the US Authority identified in Section IV and recognised by the Joint Committee, in accordance with the recognition procedures in the Agreement and Council Directive 73/23/EEC.
Conformance with the appropriate ISO/IEC Guides or the corresponding EN-45000 series of standards shall be deemed consistent with US requirements identified in Section I.
Conformance with the appropriate EN-45000 series of standards or the corresponding ISO/IEC Guides shall be deemed consistent with the requirements of Council Directive 73/23/EEC.
For purposes of designation and listing, EC Designating Authorities identified in Section IV shall designate conformity assessment bodies located in the EC by filing a properly prepared proposal for listing, which includes a complete lab assessment under the US OSHA procedures. OSHA shall notify the EC Designating Authority normally within 30 days as to whether the proposal is complete or whether additional information is required.
For purposes of designating and listing, the US Designating Authority identified in Section IV shall designate conformity assessment bodies located in the US by filing a properly prepared proposal for listing with the EC, which includes a complete lab assessment under the following EC or Member State procedures, as appropriate.
OSHA shall rely on the EC Designating Authorities identified in Section IV for conducting on-site reviews at the respective Member States' conformity assessment bodies.
The EC shall notify the US Designating Authority within 30 days as to whether the proposal is complete and shall indicate, where applicable, any additional information that is required.
Upon receipt of a complete proposal, the US exercising its authority under its law shall:
prior to the 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. 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;
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.
Upon receipt of a complete proposal, the EC shall give notice of consent or objection to the Joint Committee within 60 days. The Joint Committee shall monitor the recognition of conformity assessment bodies and confirm such a recognition by listing them in Section V of this Sectoral Annex.
EC conformity assessment bodies listed in Section V shall have NRTL status in the US.
The US conformity assessment bodies listed in Section V shall have Notified Body status within the EC.
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.
JOINT SECTORAL COMMITTEEFORELECTRICAL SAFETY
The Joint Sectoral Committee for Electrical Safety (JSC/ES) consists of representatives of the US and the EC. OSHA shall represent the US on this Joint Sectoral Committee. The EC and OSHA may invite the participation of others as deemed necessary. Each Party shall have one vote and decisions shall be made by unanimous consent, unless otherwise specified herein. The Joint Sectoral Committee shall determine its own rules of procedure.
The Joint 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;
enhancing the operation of this Sectoral Annex.
SECTORAL ANNEX FOR RECREATIONAL CRAFT
The purpose of this Sectoral Annex is to establish a framework to accept certificates of conformity issued in the territory of one Party in accordance with the regulatory requirements of the other Party as referenced in this Sectoral Annex.
To facilitate that purpose, a transitional period of 18 months is arranged to build confidence as defined in this Sectoral Annex, Section VI.
LEGISLATIVE, REGULATORY, AND ADMINISTRATIVE REQUIREMENTS
For the European Community:
Directive 94/25/EC of the European Parliament and of the Council of 16 June 1994 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to recreational craft.
46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.
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.
The product coverage for each Party shall be determined by the following relevant requirements:
Recreational craft as defined in Directive 94/25/EC;
Any product falling under the scope of 46 USC Chapter 43, 33 CFR 81, 84, 159, 179, 181, 183 and 46 CFR 58.
The Parties agree that for mutual recognition to operate under this Sectoral Annex, the following arrangements shall apply:
for approvals to European Community requirements, conformity assessment bodies designated by the US shall establish compliance as required to be demonstrated by Directive 94/25/EC. This demonstration of compliance shall be recognised 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;
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 US market for sale as recreational craft, pursuant to Section I.
AUTHORITIES RESPONSIBLE FOR DESIGNATING THE CONFORMITY ASSESSMENT BODIES
Ministère des Communications et de l'infrastructure
Ministère de l'Equipment, des Transports et du Logement
Merenkulkuhallitus/sjöfartsstyrelsen
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.
Each Party agrees that the listed conformity assessment bodies comply with the requirements for such bodies established by the other Party. These are:
for the European Community, bodies which are Notified Bodies in accordance with Directive 94/25/EC, are deemed to be in compliance with US requirements;
for the US, 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.
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.
(to be provided by EC)
There shall be a transitional period of 18 months prior to the operations of this Sectoral Annex.
The purpose of the transitional arrangement is to provide a mean 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.
During this transitional period, the parties shall:
exchange information on technical data and conformity assessment criteria and procedures, thus developing greater familiarity with their respective regulatory requirements; and
carry out or recommend any applicable policy, legislative and regulatory changes necessary for the provisions of this Annex.
All products covered by Section II of this Annex.
During this transitional period, both Parties shall endeavour to sponsor jointly seminars for the purpose of improving the understanding of technical specifications applicable in each Party's jurisdiction.
Inspections or audits shall be permitted to verify compliance of conformity assessment bodies with their responsibilities under this Agreement. The scope of these inspections or audits shall be agreed upon in advance by both Parties.
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.
The Parties note that, to the extent that requirements for electrical safety or electromagnetic compatibility may apply to products covered by this Sectoral Annex, the provisions of the Sectoral Annexes on Electrical Safety and Electromagnetic Compatibility apply.
‘Notified Body’ means a third party authorised 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.
SECTORAL ANNEX FOR PHARMACEUTICAL GOOD MANUFACTURING PRACTICES (GMPs)
DEFINITIONS, PURPOSE, SCOPE AND COVERAGE
1. ‘Equivalence’ of the regulatory systems means that the systems are sufficiently comparable to assure that the process of inspection and the ensuing inspection reports will provide adequate information to determine whether respective statutory and regulatory requirements of the authorities have been fulfilled. ‘Equivalence’ does not require that the respective regulatory systems have identical procedures.
2. ‘Enforcement’ means action taken by an authority to protect the public from products of suspect quality, safety and efficacy or to assure that products are manufactured in compliance with appropriate law, regulations, standards and commitments made as part of the approval to market a product.
3. ‘Good Manufacturing Practices’ (GMPs): (The US 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 Authorisation/Product Authorisation or License holder or applicant and ensures the product is made in compliance with its specifications (Qualified Person certification in the EC).
4. ‘Inspection’ means an on-site evaluation of a manufacturing facility to determine whether such manufacturing facility is operating in compliance with Good Manufacturing Practices and/or commitments made as part of the approval to market a product.
5. ‘Inspection Report’ means the written observations and Good Manufacturing Practices compliance assessment completed by an authority listed in Appendix 2.
6. ‘Regulatory System’ means the body of legal requirements for Good Manufacturing Practices, inspections, and enforcements that ensure public health protection and legal authority to assure adherence to these requirements.
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.
The provisions of this Annex shall apply to pharmaceutical inspections carried out in the United States and Member States of the European Community before products are marketed (hereafter referred to as ‘pre-approval inspections’ as well as during their marketing (hereafter referred to as ‘post-approval inspections’).
Appendix 1 names the laws, regulations and administrative provisions governing these inspections and the GMPs requirements.
Appendix 2 lists the authorities participating in activities under this Annex.
Articles 6, 7, 8, 9, 10 and 11 of the Agreement do not apply to this Annex.
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.
Length of transition period
A three-year transition period will start immediately after the effective date of the Agreement.
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.
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.
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.
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).
Equivalence is established by having in place regulatory systems covering the criteria referred to in Appendix 4, and a demonstrated pattern of consistent performance in accordance with these criteria. A list of authorities determined as equivalent shall be agreed to by the Joint Sectoral Committee at the end of the transition period, with reference to any limitation in terms of inspection type (e. g. post-approval or pre-approval) or product classes or processes.
The Parties will document insufficient evidence of equivalence lack of opportunity to assess equivalence or a determination of non-equivalence, in sufficient detail to allow the authority being assessed to know how to attain equivalence.
Authorities not currently listed as 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.
Start of the operational period
The operational period shall start at the end of the transition period and its provisions apply to inspection reports generated by authorities listed as equivalent for the inspections performed in their territory.
In addition, when an authority is not listed as equivalent based on adequate experience gained during the transition period, the 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 out 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 authorisation and signed by the person responsible for releasing the batch/lot.
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.
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.
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.
Reports of pre-approval inspections will be sent within 45 calendar days of the request that transmitted the appropriate information and detailed the precise issued to be addressed during the inspection. A shorter time may be necessary in exceptional cases and these will be described in the request.
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.
Each Party has the right to contest the equivalence of an authority. This right will be exercised in an objective and reasoned manner in writing to the other Party. The issue shall be discussed in the Joint Sectoral Committee promptly upon such notification. Where the JSC determines that verification of equivalence is required, it may be carried out jointly by the Parties in a timely manner, pursuant to Article 6.
Efforts will be made by the Joint Sectoral Committee to reach unanimous consent on the appropriate action. If agreement to suspend is reached in the Joint Sectoral Committee, an authority may be suspended immediately thereafter. If no agreement is reached in the Joint Sectoral Committee, the matter is referred to the Joint Committee. If no unanimous consent is reached within 30 days after such notification, the contested authority will be suspended.
Upon the suspension of an authority previously listed as equivalent, a Party is no longer obligated to endorse normally the inspection reports of the suspended authority. A Party shall continue to endorse normally 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.
Role and composition of the Joint Sectoral Committee
A Joint Sectoral Committee is set up to monitor the activities under both the transitional and operational phases of this Annex.
The Committee will be co-chaired by a representative of FDA for the 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:
making a joint assessment, which must be agreed by both Parties, of the equivalence of the respective authorities;
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;
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;
consideration of the issue of suspension.
The Joint Sectoral Committee shall meet at the request of either Party and, unless the co-chairs otherwise agree, at least once each year. The Joint Committee will be kept informed of the agenda and conclusions of meetings of the Joint Sectoral Committee.
The Parties and authorities shall inform and consult one another, as permitted by law, on proposals to introduce new controls or to change existing technical regulations or inspection procedures and to provide the opportunity to comment on such proposals.
The Parties shall notify each other in writing of any changes to Appendix 2.
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.
The details of an alert system will be developed during the transitional period. The system will be maintained in place at all times. Elements to be considered in developing such a system are described in Appendix 5.
Contact points will be agreed between both Parties to permit authorities to be made aware with the appropriate speed in case of quality defect, recalls, counterfeiting and other problems concerning quality, which could necessitate additional controls or suspension of the distribution of the product.
Each Party recognises 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.
List of applicable laws, regulations and administrative provisions
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.
Council Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use.
Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation 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.
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.
In the United States, the regulatory authority is the Food and Drug Administration.
In the European Community, the regulatory authorities are the following:
National Drug Organization (E.O.F)
for veterinary medicinal products:
for human and veterinary (non-immunologicals):
Instituto da Farmácia e do Medicamento — INF ARMED
for veterinary immunologicals:
Direcção — Geral de Veterinaria
Lääkelaitos/Läkemedelsverket
(National Agency for Medicines)
Läkemedelsverket — Medical Products Agency
Indicative list of Products covered by the Sectoral Annex
Recognising that precise definitions of medicinal products and drugs are to be found in the legislation referred to above, an indicative list of products covered by the agreement is given below:
human medicinal products including prescription and non-prescription drugs,
human biologicals including vaccines, and immunologicals,
veterinary pharmaceuticals, including prescription and non-prescription drugs, with the exclusion of veterinary immunologicals,
pre-mixes for the preparation of veterinary medicated feeds (EC), Type A medicated articles for the preparation of veterinary medicated feeds (US),
intermediate products and active pharmaceutical ingredients or bulk pharmaceuticals (US)/starting materials (EC).
Criteria for Assessing Equivalence for Post- and Pre-Approval
Legal/Regulatory authority and structures and procedures providing for post- and pre-approval:
Appropriate statutory mandate and jurisdiction.
Ability to issue and update binding requirements and GMPs and guidance documents.
Authority to make inspections, review and copy documents, and to take samples and collect other evidence.
Ability to enforce requirements and to remove products found in violation of such requirements from the market.
Substantive current good manufacturing requirements.
Accountability of the regulatory authority.
Inventory of current products and manufacturers.
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.
Mechanisms in place to assure appropriate professional standards and avoidance of conflicts of interest.
Administration of the regulatory authority:
Standards of education/qualification and training.
Effective quality assurance systems measures to ensure adequate job performance.
Appropriate staffing and resources to enforce laws and regulations.
Conduct of Inspections:
Adequate pre-inspection preparation, including appropriate expertise of investigator/team, review of firm/product and databases, and availability of appropriate inspection equipment.
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.
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.
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.
Effective Use of Surveillance Systems:
Recall monitoring.
Product defect reporting system.
Routine surveillance inspections.
Verification of approved manufacturing process changes to marketing authorisations/approved applications.
Additional specific criteria for pre-approval inspections
Satisfactory demonstration through a jointly developed and administered training program and joint inspections to assess the authorities' capabilities.
Pre-inspection preparation includes the review of appropriate records, including site plans and drug master file or similar documentation to enable adequate inspections.
Ability to verify chemistry, manufacturing and control data supporting an application is authentic and complete.
Ability to access and evaluate research and development data as scientifically sound, especially transfer technology of pilot, scale up and full scale production batches.
Ability to verify conformity of the on site processes and procedures with those described in the application.
Review and evaluate equipment installation, operational and performance qualification data, and evaluate test method validation.
Elements to be Considered in Developing a Two-way Alert System
Defintion of a crisis/emergency and under what circumstances an alert is required,
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,
3. Enforcement Procedures
Follow-up mechanisms,
Pharmacovigilance programme,
Surveillance/monitoring of implementation of corrective action.
For the purpose of this agreement, the contact points for the alert system will be:
the Executive Director of the European Agency for the Evaluation of Medicinal Products,
7, Westferry Circus,
UK - London E14 4HB,
Telephone +44- 171- 418 8400,
Fax 418 8416.
SECTORAL ANNEX ON MEDICAL DEVICES
This Annex constitutes a Sectoral Annex to the Agreement on Mutual Recognition in Regulation 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.
PURPOSE, SCOPE AND COVERAGE OF THE SECTORAL ANNEX
1. The purpose of this Annex is to specify the conditions under which a Party will accept the results of quality system-related evaluations and inspections and premarket evaluations of the other Party with regard to medical devices as conducted by listed conformity assessment bodies (CABs) and to provide for other related cooperative activities.
2. This Annex is intended to evolve as programmes and policies of the Parties evolve. The Parties will review this Annex periodically, in order to assess progress and identify potential enhancements to this Annex as Food and Drug Administration (FDA) and EC policies evolve over time.
1. The provisions of this Annex shall apply to the exchange and, where appropriate, endorsement of the following types of reports from CABs assessed to be equivalent:
under the US system, surveillance/post-market and initial/pre-approval inspection reports;
under the US system, premarket (510(k)) product evaluation reports;
under the EC system, quality system evaluation reports; and
under the EC system, EC type examination and verification reports.
Appendix 1 names the legislation, regulations, and related procedures under which:
products are regulated as medical devices by each Party;
CABs are designated and confirmed; and
these reports are prepared.
2. For purposes of this Annex, equivalence means that: CABs in the EC are capable of conducting product and quality systems evaluations against US regulatory requirements in a manner equivalent to those conducted by FDA; and CABs in the US are capable of conducting product and quality systems evaluations against EC regulatory requirements in a manner equivalent to those conducted by EC CABs.
There are three components to this agreement each covering a discrete range of products:
Quality System Evaluations — US-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 US and EC law as medical devices.
Product Evaluation — US-type premarket (510(k)) product evaluation reports and EC-type-testing reports will be exchanged only with regard to those products classified under the US system as Class I/Class II — Tier 2 medical devices which are listed in Appendix 2.
Post-Market Vigilance Reports — Post-market vigilance reports will be exchanged with regard to all products regulated under both US and EC law as medical devices.
Additional products and procedures may be made subject to this Annex by agreement of the Parties.
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.
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.
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.
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.
2. The joint confidence building program should include the following actions and activities:
seminars designed to inform the Parties and CABs about each Party's regulatory system, procedures, and requirements;
workshops designed to provide the Parties with information regarding requirements and procedures for the designation and surveillance of CABs;
exchange of information about reports prepared during the transition period;
joint training exercises; and
observed inspections.
3. During the transition period, any significant problem that is identified with a CAB may be the subject of cooperative activities, as resources allow and as agreed to by the regulatory authorities, aimed at resolving the problem.
4. Both Parties will exercise good faith efforts to complete the confidence building activities as expeditiously as possible to the extent that the resources of the Parties allow.
5. Both the EC and the US 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.
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.
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.
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.
Exchange and endorsement of quality system evaluation reports
1. Listed EC CABs will provide FDA with reports of quality system evaluations, as follows:
for pre-approval quality system evaluations, EC CABs will provide full reports; and
for surveillance quality system evaluations, EC CABs will provide abbreviated reports.
2. Listed US CABs will provide to the EC Notified Body of the manufacturer's choice:
full reports of initial quality system evaluations;
abbreviated reports of quality systems surveillance audits.
3. If the abbreviated reports do not provide sufficient information, the importing Party may request additional clarification from the CAB.
4. Based on the determination of equivalence in light of the experience gained, the quality system evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies or inadequacies in a report, quality defects identified in post-market surveillance or other specific evidence of serious concern in relation to product quality or consumer safety. In such cases, the importing Party may request clarification from the exporting Party which may lead to a request for re-inspection. The Parties will endeavour to respond to requests for clarification in a timely manner. Where divergence is not clarified in this process, the importing Party may carry out the quality system evaluation.
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 US medical device requirements.
2. US CABs will, subject to the specifications and limitations on the list, provide to the EC notified body of the manufacturer's choice, type examination and verification reports prepared to EC medical device requirements.
3. Based on the determination of equivalence in light of the experience gained, the product evaluation reports prepared by the CABs listed as equivalent will normally be endorsed by the importing Party, except under specific and delineated circumstances. Examples of such circumstances include indications of material inconsistencies, inadequacies, or incompleteness in a product evaluation report, or other specific evidence of serious concern in relation to product safety, performance, or quality. In such cases, the importing Party my 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 timely manner. Endorsement remains the responsibility of the importing Party.
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 time, the importing Party may perform an inspection on its own.
Transmission of product evaluation reports
Transmission of product evaluation reports will take place according to the importing Party's specified procedures.
Monitoring activities will be carried out in accordance with Article 10 of the Agreement.
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 Articles 7(a) and (b) of the Agreement.
3. Following such annual designations, the procedures for confirmation of CABs under Articles 7(c) and (d) of the Agreement shall apply.
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 US 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:
making a joint assessment of the equivalent of CABs;
developing and maintaining the list of equivalent CABs, including any limitation in terms of their scope of activities and communicating the list of all authorities and the Joint Committee;
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
HARMONISATION AND INFORMATION EXCHANGE
During both the transitional and operational phases of this Agreement, both Parties intend to continue to participate in the activities of the Global Harmonisation Task Force and utilise the results of those activities to the extent possible. Such participation involves developing and reviewing documents developed by the Global Harmonisation Task Force and jointly determining whether they are applicable to the implementation of this Agreement.
The Parties and authorities shall inform one another, as permitted by law, of, and consult one another 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 1.
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.
Relevant legislation, regulations and procedures
For the European Community the following legislation applies to Article 2(1):
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),
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Conformity assessment procedures.
Annex V,
For the United States, the following legislation applies to Article 2(1):
The Federal Food, Drug and Cosmetic Act, 21. U.S.C. §§ 321 et seq.;
The Public Health Service Act, 42 U.S.C. §§ 201 et seq.;
Regulations of the United States Food and Drug Administration found at 21 C.F.R., in particular, Parts 800 to 1299;
Medical Devices; Third-Party Review of Selected Premarket Notifications; Pilot Program, 61 Fed. Reg. 14,789-14,796 (April 3, 1996).
Scope of product coverage
Initial Coverage of the Transition Period:
Upon entry into force of this Annex (1), products qualifying for the transitional arrangements under this Agreement include:
all Class I products requiring premarket evaluations in the United States — see Table 1;
those Class II products listed in Table 2.
The Parties will jointly identify additional product groups, including their related accessories, in line with their respective priorities as follows:
those for which review may be based primarily on written guidance which the Parties will use their best efforts to prepare expeditiously; and
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.
Commencement of the Operational Period:
at the commencement of the operational period, product coverage shall extend to all Class I/II products covered during the transition period;
the 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 US.
Unless explicitly included by joint decision of the Parties, this agreement does not cover any US Class II-tier 3 or any Class III product under either system.
Class I products requiring premarket evaluations in the United States, included in scope of product coverage at beginning of transition period
Product Code — Device Name
ANESTHESIOLOGY PANEL (868)
868.1910
Stethoscope, esophageal
868.5620
Breathing mouthpiece
Mouthpiece, breathing
868.5640
Medicinal nonventilatory nebulizer (atomizer)
Nebulizer, medicinal, non-ventilatory (atomizer)
868.5675
Rebreathing device
Device, rebreathing
868.5700
Nonpowered oxygen tent
Hood, oxygen, infant
Catheters, suction, tracheobronchial
DENTAL PANEL (872)
Karaya and sodium borate with or without acacia denture adhesive
Adhesive, denture, acacia and karaya with sodium borate
872.3700
Dental mercury (USP)
872.4200
Controller, foot, handpiece and cord
Handpiece, air-powered, dental
Handpiece, belt and/or gear driven, dental
Handpiece, contra- and right-angle attachment, dental
Handpiece, direct drive, ac-powered
Handpiece, water-powered
872.6640
Dental operative unit
Unit, operative dental
EAR, NOSE, AND THROAT PANEL (874)
874.1070
Short increment sensitivity index (SISI) adapter
Adapter, short increment sensitivity index (SISI)
874.1500
874.1800
Air or water caloric stimulator
Stimulator, caloric-air
Stimulator, caloric-water
874.1925
Tube, toynbee diagnostic
874.3300
Face plate hearing-aid
Hearing-aid, air-conduction
874.4100
Balloon, epistaxis
874.5300
Examination and treatment unit
Unit, examining/treatment, ent
874.5550
Powered nasal irrigator
Irrigator, powered nasal
874.5840
Anti-stammering device
Device, anti-stammering
GASTROENTEROLOGY — UROLOGY PANEL (876)
Urological clamps for males
Clamp, penile
876.5210
Kit, enema, (for cleaning purpose)
Urine collector and accessories
Bag, urine collection, leg, for external use
GENERAL HOSPITAL PANEL (880)
880.5270
Neonatal eye pad
Pad, neonatal eye
880.5420
Pressure infuser for I.V. bag
Infusor, pressure, for I.V. bags
880.5680
Pediatric position holder
Holder, infant position
Patient examination glove
Glove, patient examination
Glove, patient examination, latex
Glove, patient examination, poly
Glove, patient examination, speciality
Glove, patient examination, vinyl
880.6375
Patient lubricant
Lubricant, patient
880.6760
Restraint, patient, conductive
Restraint, protective
NEUROLOGY PANEL (882)
882.1030
882.1420
Electroencephalogram (EEG) signal spectrum analyser
Analyser, spectrum, electroencephalogram signal
882.4060
Cannula, ventricular
882.4545
Shunt system implantation instrument
Instrument, shunt system implantation
882.4650
Neurosurgical suture needle
Needle, neurosurgical suture
882.4750
Punch, skull
OBSTETRICS AND GYNECOLOGY PANEL
OPHTHALMOLOGY PANEL (886)
886.1940
Tonometer sterilizer
sterilizer, tonometer
Burr, corneal, ac-powered
Burr, corneal, battery-powered
Engine, trephine, accessories, ac-powered
Engine, trephine, accessories, battery-powered
Engine, trephine, accessories, gas-powered
Keratone, ac-powered
Keratone, battery-powered
Sunglasses (non-prescription including photosensitive)
ORTHOPEDIC PANEL (888)
888.1500
Ac-powered goniometer
Goniometer, ac-powered
888.4150
Callipers for clinical use
PHYSICAL MEDICINE PANEL (890)
890.3850
Mechanical wheelchair
Stroller, adaptive
Wheelchair, mechanical
890.5180
Manual patient rotation bed
Bed, patient rotation, manual
890.5710
Hot or cold disposable pack
Pack, hot or cold, disposable
RADIOLOGY PANEL (892)
892.1100
Scintillation gamma camera
Camera, scintillation (gamma)
892.1110
892.1300
Nuclear rectilinear scanner
Scanner, rectilinear, nuclear
892.1320
Nuclear uptake probe
Probe, uptake, nuclear
892.1330
Nuclear whole body scanner
Scanner, whole body, nuclear
892.1410
Nuclear electrocardiograph synchroniser
Synchroniser, electrocardiograph, nuclear
892.1890
Radiographic-film illuminator
Illuminatore radiographic-film
Illuminatore radiographic-film, explosion-proof
892.1910
Grid, radiographic
892.1960
Screen, intensifying, radiographic
892.1970
Radiographic ECG/respirator synchroniser
Synchroniser, ECG/respirator, radiographic
892.5650
Manual radionuclide applicator system
System, applicator, radionuclide, manual
GENERAL AND PLASTIC SURGERY PANEL (878)
878.4200
Introduction/drainage catheter and accessories
Accessories, catheter
Adaptor, catheter
Cannula, injection
Catheter, balloon type
Catheter, cholangiography
Catheter, continuous irrigation
Catheter, eustachian, general & plastic surgery
Catheter, infusion
Catheter, irrigation
Catheter, multiple lumen
Catheter, nephrostomy, general & plastic surgery
Catheter, pediatric, general & plastic surgery
Catheter, peritoneal
Catheter, ventricular, general & plastic surgery
Connector, catheter
Dilator, catheter
Needle, catheter
878.4320
Removable skin clip
Clip, removable (skin)
878.4680
Nonpowered, single patient, portable suction apparatus
Apparatus, suction, single patient use, portable, nonpowered
878.4760
Removable skin staple
Staple, removable (skin)
878.4820
Ac-powered, battery-powered, and pneumatically powered surgical instrument motor
Bit, surgical
Blade, saw, general and plastic surgery
Blade, saw, surgical, cardiovascular
Board, arm (with cover)
Brush, dermabrasion
Bur, surgical, general and plastic surgery
Chisel (osteotome)
Driver, surgical, pin
Head, surgical, hammer
Motor, surgical instrument, ac-powered
Motor, surgical instrument, pneumatic powered
Saw, electrically powered
Saw, pneumatically powered
Saw, powered, and accessories
878.4960
Air or ac-powered operating table and air or ac-powered operating chair and accessories
Chair, surgical, ac-powered
Tabel, operating-room, ac-powered
Tabel, operating-room, electrical
Tabel, operating-room, pneumatic
Tabel, surgical with orthopedic accessories, ac-powered
880.5090
Bandage, liquid
Class II medical devices included in scope of product coverage at beginning of transition period
(US to develop guidance documents identifying US requirements and EC to identify standards needed to meet EC requirements)
892.1000
Magnetic resonance diagnostic device
Coil, magnetic resonance, specialty
System, nuclear magnetic resonance spectroscopic
892.1540
Nonfetal ultrasonic monitor
Monitor, ultrasonic, nonfetal
892.1550
Ultrasonic pulsed doppler imaging system
892.1560
Ultrasonic pulsed echo imaging system
System, imaging, pulsed echo, ultrasonic
892.1570
Diagnostic ultrasonic transducer
Transducer, ultrasonic, diagnostic
DIAGNOSTIC X — RAY IMAGING DEVICES
(except mammographic x-ray systems)
892.1600
Angiographic x-ray system
System, x-ray, angiographic
Image-intensified fluoroscopic x-ray system
Solid state x-ray imager (flat panel/digital imager)
System, x-ray, fluoroscopic, image-intensified
892.1680
System, x-ray, stationary
892.1720
892.1740
Tomographic x-ray system
System, x-ray, tomographic
892.1750
Computed tomography x-ray system
ECG-RELATED DEVICES
870.2340
Monitor, st segment
870.2350
Electrocardiograph lead switching adaptor
Adaptor, lead switching, electrocardiograph
870.2360
Electrocardiograph electrode
Electrode, electrocardiograph
870.2370
Electrocardiograph surface electrode tester
Tester, electrode, surface, electrocardiographic
880.5725
Infusion pump (external only)
Accessories, pump, infusion
Pump, infusion
Pump, infusion, analytical sampling
Pump, infusion, elastomeric
Pump, infusion, enteral
Pump, infusion, gallstone dissolution
Pump, infusion, pca
Ophthalmoscope, ac-powered
Ophthalmoscope, battery-powered
Retinoscope, ac-powered
Biomicroscope, slit-lamp, ac-powered
Dilator, expansive iris (accessory)
Instrument, vitreous aspiration and cutting, ac-powered
Instrument, vitreous aspiration and cutting, battery-powered
Vitrectomy, instrument cutter
Unit, phacofragmentation
878.4580
Illuminator, fiberoptic, surgical field
Illuminator, non-remote
Illuminator, remote
Lamp, fluorescent, ac-powered
Lamp, operating-room
Lamp, surgical
Lamp, surgical, incandescent
Light, surgical, accessories
Light, surgical, carrier
Light, surgical, ceiling mounted
Light, surgical, connector
Light, surgical, endoscopic
Light, surgical, fiberoptic
Light, surgical, floor standing
Light, surgical, instrument
882.5890
Transcutaneous electrical nerve stimulator for pain relief
NON-INVASIVE BLOOD PRESSURE MEASUREMENT DEVICES
870.1120
Cuff, blood-pressure
870.1130
Non-invasive blood pressure measurement system (except non-oscillometric)
880.6880
Steam steriliser (greater than 2 cubic feet)
Steriliser, steam
880.2910
Clinical electronic thermometer (except tympanic or pacifier)
Thermometer, electronic, clinical
868.5630
Nebuliser (direct patient interface)
868.5925
Powered Emergency ventilator
(except anti-stick and self-destruct)
880.5570
Hypodermic single lumen needle
Container, sharpes
Needle, hypodermic, single lumen
Port, intraosseous, implanted
880.5860
Syringe, piston
888.3020
Rod, fixation, intramedullary and accessories
(except devices with no external components)
888.3030
Single/multiple component metallic bone fixation appliances and accessories
Appliance, fixation, nail/blade/plate combination, multiple component
Smooth or threaded metallic bone fixation fastener
Pin, fixation, smooth
Pin, fixation, threaded
SELECTED DENTAL MATERIALS
872.3060
Gold based alloys and precious metal alloys for clinical use
Alloy, gold based, for clinical use
Alloy, precious metal, for clinical use
872.3200
Resin tooth bonding agent
Agent, tooth bonding, resin
872.3275
Cement, dental
872.3660
Material, impression
872.3690
Tooth shade resin material
Material, tooth shade, resin
872.3710
Metal, base
884.5300
Medical devices for possible inclusion in scope of product coverage during operational period
ANAESTHESIOLOGY PANEL
868.5160
Gas machine for anesthesia or analgesia
868.5270
Breathing system heater
868.5440
868.5450
868.5710
Electrically powered oxygen tent
868.5880
868.1040
Powered Algesimeter
868.1075
Argon gas analyser
868.1400
868.1430
Carbon monoxide gas analyser
868.1500
Enflurane gas analyser
868.1620
Halothane gas analyser
868.1640
Helium gas analyser
868.1670
Neon gas analyser
868.1690
868.1700
Nitrous oxide gas analyser
868.1720
868.1730
Oxygen uptake computer
868.2775
Electrical peripheral nerve stimulator
868.1750
868.1760
Volume plethysmograph
868.1780
Inspiratory airway pressure meter
868.1800
868.1840
868.1850
Monitoring spirometer
868.1860
Peak-flow meter for spirometry
868.1880
Pulmonary-function data calculator
868.1890
Predictive pulmonary-function value calculator
868.1900
Diagnostic pulmonary-function interpretation calculator
868.2025
Ultrasonic air embolism monitor
Breathing frequency monitor (except apnea detectors)
868.2480
Cutaneous carbon dioxide (PcCO2) monitor
Cutaneous oxygen monitor (for an infant not under gas anesthesia)
868.2550
Pneumotachomometer
868.2600
868.5665
Powered percussor
868.5690
868.5905
Nonconinuous ventilator (IPPB)
868.5935
External negative pressure ventilator
868.5895
868.5955
Intermittent mandatory ventilation attachment
870.1425
Programmable diagnostic computer
870.1450
870.2310
Apex cardiograph (vibrocardiograph)
870.2320
870.2400
Vectorcardiograph
870.2450
Medical cathode-ray tube display
870.2675
870.2840
Apex cardiographic transducer
870.2860
Heart sound transducer
Valve, pressure relief, cardiopulmonary bypass
870.1100
Blood pressure alarm
870.1110
Blood pressure computer
870.1140
Venous blood pressure manometer
870.1220
Electrode recording catheter or electrode recording probe
870.1270
Intracavitary phonocatheter system
870.1875
Stethoscope (electronic)
870.2050
Biopotential amplifier and signal conditioner
870.2060
Transducer signal amplifier and conditioner
870.2100
Cardiovascular blood flow-meter
870.2120
Extravascular blood flow probe
870.2300
Cardiac monitor (including) cardiotachometer and rate alarm)
870.2700
870.2710
870.2750
Impedance phlebograph
870.2770
870.2780
Hydraulic, pneumatic, or photoelectric plethysmographs
870.2850
Extravascular blood pressure transducer
870.2870
870.2880
870.2890
Vessel occlusion transducer
870.2900
Patient transducer and electrode cable (including connector)
870.2910
Radiofrequency physiological signal transmitter and receiver
870.2920
Telephone electrocardiograph transmitter and receiver
870.4205
Cardiopulmonary bypass bubble detector
870.4220
Cardiopulmonary bypass heart-lung machine console
870.4240
Cardiovascular bypass heat exchanger
870.4250
Cardiopulmonary bypass temperature controller
870.4300
Cardiopulmonary bypass gas control unit
870.4310
Cardiopulmonary bypass coronary pressure gauge
870.4330
Cardiopulmonary bypass on-line blood gas monitor
870.4340
Cardiopulmonary bypass level sensing monitor and/or control
870.4370
Roller-type cardiopulmonary bypass blood pump
870.4380
Cardiopulmonary bypass pump speed control
870.4410
Cardiopulmonary bypass in-line blood gas sensor
870.5050
Patient care suction apparatus
870.5900
870.5300
DC-defibrillator (including paddles)
870.5325
870.2330
Pacemaker and Accessories
870.1750
External programmable pacemaker pulse generator
870.3630
Pacemaker generator function analyser
870.3640
Indirect pacemaker generator function anlayser
870.3720
Pacemaker electrode function tester
870.1800
Withdrawal-infusion pump
870.2800
Medical magnetic tape recorder
Batteries, rechargeable, Class II devices
872.1720
872.1740
872.4120
Bone cutting instrument and accessories
872.4465
872.4475
Spring-powered jet injector
872.4600
Intraoral ligature and wire lock
872.4840
872.4850
872.4920
Dental electrosurgical unit and accessories
872.6070
Ultraviolet activator for polymerisation
872.6350
872.3050
Gold-based alloys and precious metal alloys for clinical use
872.3250
872.3260
Dental cement (other than zinc oxide-eugenol)
872.3300
Hydrophilic resin coating for dentures
872.3310
Coating material for resin fillings
872.3590
872.3750
Bracket adhesive resin and tooth conditioner
872.3760
872.3765
Pit and fissure sealant and conditioner
872.3770
Temporary crown and bridge resin
872.3820
Root canal filling resin (other than chloroform use)
872.3920
872.1800
Extraoral source x-ray system
872.1810
Intraoral source x-ray system
872.4880
Intraosseous fixation screw or wires
872.3890
Endodontic stabilising splint
872.5470
Orthodontic plastic bracket
EAR/NOSE/THROAT PANEL
874.1050
874.1090
874.1120
Electronic noise generator for audiometric testing
874.1325
874.1820
Surgical nerve stimulator/locator
Hearing aid (for bone-conduction)
874.3310
Hearing aid calibrator and analysis system
874.3320
Group hearing aid or group auditory trainer
874.3330
874.4250
Ear, nose, and throat electric or pneumatic surgical drill
874.4490
Argon laser for otology, rhinology, and laryngology
874.4500
ENT microsurgical carbon dioxide laser
GASTROENTEROLOGY/UROLOGY PANEL
Endoscope (including angioscopes, laparscopes, ophtalmic endoscopes)
876.1500
876.4300
Endoscopic electrosurgical unit and accessories
876.1725
Gastrointestinal motility monitoring system
876.5600
Sorbent regenerated dialysate delivery system for hemodialysis
876.5630
Peritoneal dialysis system and accessories
876.5665
876.5820
Hemodialysis system for accessories
876.5830
Hemodialyser with disposable insert (kiil-type)
876.4500
876.1620
Urodynamics measurement system
876.5320
Nonimplanted electrical continence device
876.5880
Isolated kidney perfusion and transport system and accessories
GENERAL HOSPITAL PANEL
Infusion Pumps and Systems
880.2420
Electronic monitor for gravity flow infusion systems
880.2460
Electrically powered spinal fluid pressure monitor
880.5430
Nonelectrically powered fluid injector
880.5400
880.5410
880.5700
Piston syringe (except anti-stick)
880.6920
Syringe needle introducer
880.2920
880.5100
AC-powered adjustable hospital bed
880.5500
AC-powered patient lift
882.1020
Rigidity analyser
882.1610
Alpha monitor
Neuro-Diagnostic
882.1320
Cutaneous electrode
882.1340
Nasopharyngeal electrode
882.1350
882.1460
882.1480
Neurological endoscope
882.1540
Galvanic skin response measurement device
882.1550
Nerve conduction velocity measurement device
882.1560
Skin potential measurement device
882.1570
Powered direct-contact temperature measurement device
882.1620
882.1835
Physiological signal amplifier
882.1845
Physiological signal conditioner
882.1855
Electroencephalogram (EEG) telemetry system
882.5050
882.1240
882.4400
Radiofrequency lesion generator
Electrode, spinal epidural
882.4305
Powered compound cranial drills, burrs, trephines and their accessories
882.4310
Powered simple cranial drills, burrs, trephines and accessories
882.4360
Electric cranial drill motor
882.4370
Pneumatic cranial drill motor
882.4560
Sterotaxic instrument
882.4725
Radiofrequency lesion probe
882.4845
Powered rongeur
882.5500
Lesion temperature monitor
882.1870
Evoked response electrical stimulator
882.1880
Evoked response mechanical stimulator
882.1890
Evoked response photic stimulator
882.1900
Evoked response auditory stimulator
882.1950
Tremor transducer
OBSTETRICS/GYNAECOLOGY PANEL
884.1660
Transcervical endoscope (amnioscope) and accessories
884.1690
Hysteroscope and accessories (for performance standards)
884.2225
884.2600
Fetal cardiac monitor
884.2640
Fetal phonocardiographic monitor and accessories
884.2660
Fetal ultrasonic monitor and accessories
884.2675
Fetal scalp circular (spiral) electrode and applicator
884.2700
Intrauterine pressure monitor and accessories
884.2720
External uterine contraction monitor and accessories
884.2740
Perinatal monitoring system and accessories
884.2960
Obstetric ultrasonic transducer and accessories
884.1720
Gynecologic laparoscope and accessories
884.4160
Unipolar endoscopic coagulator-cutter and accessories
884.4550
Gynecologic surgical laser
884.4120
Gynecologic electrocautery and accessories
Ophthalm. Implants
886.3320
Eye sphere implant
Polymethylmethacrylate (PMMA) diagnostic contact lens
Rigid gas permeable contact lens (daily wear only)
Ophthalmic camera
Euthyscope (AC-powered)
Retinoscope (AC-powered device)
AC-powered slitlamp biomicroscope
Transilluminator (AC-powered device)
886.3130
Ophthalmic conformer
(Diagnostic/Surgery Equipment)
886.3340
Extraocular orbital implant
886.3800
886.5725
Infusion pump (performance standards)
886.3100
Ophthalmic tantalum clip
886.3300
Absorbable implant (scleral buckling method)
Radiofrequency electrosurgical cautery apparatus
Ophthalmic electrolysis unit (AC-powered device)
Operating headlamp (AC-powered device)
Ophthalmoscopes, replacement batteries, hand-held
888.3010
Bone fixation cerclage
Single/multiple component metallic bone fixation appliance and accessories
Smooth or threaded metallic bone fixation
888.3050
Spinal interlaminal fixation orthosis
888.3060
Spinal intervertebral body fixation orthosis
888.1240
AC-powered dynamometer
888.4580
Sonic surgical instrument and accessories/attachments
Accessories, fixation, spinal interlaminal
Accessories, fixation, spinal intervertebral body
Monitor, pressure, intracompartmental
Orthosis, fixation, spinal intervertebral fusion
Orthosis, spinal pedicle fixation
System, cement removal extraction
PHYSICAL MEDICINE PANEL
890.1225
890.1375
Diagnostic electromyograph
890.1385
Diagnostic electromyograph needle electrode
890.1450
Powered reflex hammer
890.1850
or (Therapy)
890.5850
890.5100
Immersion hydrobath
890.5110
890.5500
890.5720
Water circulating hot or cold pack
890.5740
Powered heating pad
RADIOLOGY PANEL
892.1610
Diagnostic x-ray beam-limiting device
892.1620
Cine or spot fluorographic x-ray Camera
892.1630
Electrostatic x-ray imaging system
892.1670
892.1710
Mammographic x-ray system
892.1820
Pneumoencephalographic chair
892.1850
892.1860
Radiographic film/cassette changer
892.1870
Radiographic film/cassette changer programmer
892.1900
Automatic radiographic film processor
892.1980
Radiologic table
892.5050
Medical charged-particle radiation therapy system
892.5300
Medical neutron radiation therapy system
892.5700
Remote controlled radionuclide-applicator system
892.5710
Radiation therapy beam-shaping block
892.5730
892.5750
Radionuclide radiation therapy system
892.5770
Powered radiation therapy patient support assembly
892.5840
Radiation therapy stimulation system
892.5930
Therapeutic x-ray tube housing assembly
892.1170
892.1200
Emission computed tomography system
892.1310
Nuclear tomography system
892.1390
Radionuclide rebreathing system
GENERAL/PLASTIC SURGERY PANEL
878.4630
Ultraviolet lamp for dermatologic disorders
Electrosurgical Cutting Equipment
Laser surgical instrument for use in general and plastic surgery and in dermatology
878.4400
Electrosurgical cutting and coagulation device and accessories
Powered suction pump
(1) It is understood that the date of entry into force will not occur prior to 1 June 1998, unless the Parties decide otherwise.
Authorities responsible for designating conformity assessment bodies
Ministère de la Santé publique, de l'Environnement et de l'Intégration sociale
Ministerie van Volksgezondheid, Leefmilieu en Sociale Inetgratie
Sosiaali-ja terveysministeriö/Social-och hälsovårdsministeriet
Conformity assessment bodies located in the EC shall be designated by the Authorities identified in Appendix 3.
Conformity assessment bodies located in the US shall be designated by the Authorities identified in Appendix 3.
to the Agreement on Mutual Recognition between the European Community and the United States of America
The Parties agree that, although in this exceptional case the Agreement on Mutual Recognition between the United States of America and the European Community is being signed while the consistency of the various linguistic versions of the Agreement is being verified, notification of the completion of their respective procedures for the entry into force of the Agreement, as referred to in Article 21(1) of the Agreement, will be made only after the Parties have completed the verification of the texts signed today and, through agreement between the Parties, any discrepancies have been brought into conformity with the English text.