02002A0430(05) — EN — 22.12.2017 — 005.001

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Amended by:









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AGREEMENT

between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment







THE EUROPEAN COMMUNITY, hereinafter referred to as ‘the Community’, and THE SWISS CONFEDERATION, hereinafter referred to as ‘Switzerland’, together hereinafter referred to as ‘the Parties’, Considering the close ties that exist between the Community and Switzerland; Considering the Free Trade Agreement of 22 July 1972 between Switzerland and the European Economic Community; Desiring to conclude an Agreement providing for the mutual recognition of the results of conformity assessment procedures required for access to the respective markets of the Parties; Considering that mutual recognition in relation to conformity assessment will facilitate trade between the Parties and ensure protection for health, safety, the environment and consumers; Considering the alignment of legislation will facilitate mutual recognition; Considering their obligations as Contracting Parties to the Agreement establishing the World Trade Organisation and, in particular, to the Agreement on Technical Barriers to Trade, which encourages the negotiation of mutual recognition agreements; Considering that mutual recognition agreements contribute to harmonisation at international level of the technical regulations, standards and principles governing implementation of conformity assessment procedures; Considering that the close ties between the Community and Switzerland, of the one part, and Iceland, Liechtenstein and Norway, of the other, makes the conclusion of parallel agreements between those countries and Switzerland appropriate, Have agreed to conclude the following Agreement:







Article 1

Purpose

1. The Community and Switzerland hereby grant mutual acceptance of reports, certificates, authorisations and conformity marks issued by the ►M8 bodies recognised in accordance with the procedures of this Agreement (hereinafter recognised conformity assessment bodies) ◄ and of the manufacturer's declarations of conformity certifying conformity to the requirements of the other Party in the areas covered by Article 3.

2. In order to avoid duplication of procedures when Swiss and Community requirements are deemed equivalent, the Community and Switzerland shall mutually accept reports, certificates and authorisations issued by ►M8 recognised conformity assessment bodies ◄ and manufacturer's declarations of conformity certifying conformity to their respective requirements in the areas covered by Article 3. Reports, certificates, authorisations and manufacturer's declarations of conformity shall in particular indicate conformity with the Community legislation. Conformity marks required by the legislation of one of the Parties must be affixed to products placed on the market of that Party.

3. The Committee provided for in Article 10 shall specify the cases in which paragraph 2 shall apply.

Article 2

Definitions

1. For the purposes of this Agreement:

‘Conformity assessment’ shall mean systematic examination to determine the extent to which a product, process or service fulfils specified requirements;

‘Conformity assessment body’ shall mean a public or private law body whose activities include performance of all or any stage of the conformity assessment process;

‘Designating authority’ shall mean an authority with the legal power to designate, suspend, withdraw designation or remove suspension of conformity assessment bodies under its jurisdiction.

2. ►M8 The definitions laid down by ISO and IEC may be used to establish the meaning of the general terms relating to conformity assessment contained in this Agreement. ◄

Article 3

Scope

1. This Agreement covers the obligatory conformity assessment procedures ensuing from the legislative, regulatory and administrative provisions listed in Annex 1.

2. Annex 1 defines the product sectors covered by this Agreement. The Annex is divided up into sectoral chapters and these are subdivided in principle as follows:

section I: legislative, regulatory and administrative provisions;

section II: conformity assessment bodies;

section III: designating authorities;

section IV: special rules relating to the designation of conformity assessment bodies;

section V: any additional provisions.

3. Annex 2 sets out general rules applicable to the designation of conformity assessment bodies.

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Article 4

Origin

The provisions of this Agreement shall apply to products covered by this Agreement irrespective of their origin.

Article 5

Recognised conformity assessment bodies

The Parties hereby agree that conformity assessment bodies recognised in accordance with the procedure provided for in Article 11 fulfil the conditions of eligibility to assess conformity.

Article 6

Designating authorities

1. The Parties hereby undertake to ensure that their designating authorities have the necessary power and competence to designate conformity assessment bodies or withdraw designation, suspend or remove suspension of designated conformity assessment bodies under their respective jurisdiction.

2. For the designation of conformity assessment bodies, the designating authorities shall observe the general principles for designation set out in Annex 2, subject to the provisions of the respective section IV in Annex 1. These designating authorities shall observe the same principles when withdrawing designation, suspending or removing suspension.

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Article 7

Verification of designation procedures

1. The Parties shall exchange information concerning the procedures used to ensure ►M8 recognised conformity assessment bodies under their jurisdiction ◄ comply with the general principles of designation outlined in Annex 2 subject to the provisions of the respective section IV in Annex 1.

2. The Parties shall compare methods used to verify conformity of the bodies with the general principles of designation outlined in Annex 2, subject to the provisions of the respective section IV in Annex 1. Existing systems for the accreditation of conformity assessment bodies in the Parties may be used for the purpose of such comparisons.

3. Verification shall be carried out in accordance with the procedure implemented by the Committee under Article 10 below.

Article 8

Verification of compliance of conformity assessment bodies

1. Each Party shall, in exceptional circumstances, have the right to contest the technical competence of the conformity assessment bodies proposed by the other Party or ►M8 of recognised conformity assessment bodies ◄ under the jurisdiction of the other Party.

For this purpose, it shall submit in writing an objective and reasoned argument to the other Party ►M8 ————— ◄ .

2. In the event of a disagreement between the Parties, confirmed in the Committee, a verification of the technical competence of the conformity assessment body in question shall be undertaken in accordance with requirements jointly by the Parties, with the participation of the competent authorities concerned.

The result of that verification shall be discussed in the Committee with a view to resolving the issue as soon as possible.

3. Each Party shall ensure that the conformity assessment bodies under its jurisdiction are available for verification of their technical competence as required.

4. Unless otherwise decided by the Committee, the disputed body shall be suspended by the competent designating authority from the time disagreement has been established until agreement has been reached in the Committee. ►M8 Such suspension shall be indicated in the common list of recognised conformity assessment bodies referred to in Annex 1. ◄

Article 9

Implementation of the Agreement

1. The Parties shall cooperate with a view to ensuring the satisfactory application of the legislative, regulatory and administrative provisions listed in Annex 1.

2. The designating authorities shall ascertain by appropriate means whether the ►M8 recognised conformity assessment bodies under their jurisdiction ◄ are observing the general principles of designation listed in Annex 2, subject to the provisions listed in the respective section IV in Annex 1.

3. ►M8 The recognised conformity assessment bodies ◄ shall cooperate in an appropriate way in the framework of the coordination and comparison work conducted by each of the Parties in respect of the sectors covered by Annex 1 in order to ensure that the conformity assessment procedures provided for in the laws and regulations of the Parties covered by this Agreement are applied in a consistent manner. ►M8 The designating authorities shall use their best endeavours to ensure that recognised conformity assessment bodies cooperate in an appropriate way. ◄

Article 10

Committee

1. A Committee on mutual recognition in relation to conformity assessment (hereinafter referred to as the ‘Committee’), is hereby established. It shall be composed of representatives of the Parties, and shall be responsible for the management and monitoring of the smooth functioning of this Agreement. To that end, it shall issue recommendations and take decisions in the circumstances provided for in this Agreement. It shall act by mutual agreement.

2. The Committee shall establish its own rules of procedure, which shall contain, inter alia, provisions on the convening of meetings, the appointment of the chairman and the chairman's term of office.

3. The Committee shall meet as and when necessary and at least once a year. Either Party may request the convening of a meeting.

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4. The Committee may consider any matter related to this Agreement. In particular, it shall be responsible for:

(a) drawing up the procedure for carrying out the verifications provided for in Article 7;

(b) drawing up the procedure for carrying out the verifications provided for in Article 8;

(c) deciding on the recognition of conformity assessment bodies contested under Article 8;

(d) deciding on the withdrawal of recognition of recognised conformity assessment bodies contested under Article 8;

(e) examining any legislative, regulatory and administrative provisions notified by one Party to another pursuant to Article 12 in order to assess their repercussions on the Agreement and to amend the appropriate sections in Annex 1.

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5. The Committee may, on a proposal from one of the Parties, modify the Annexes to this Agreement.

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Article 11

Recognition, withdrawal of recognition, modification of the scope, and suspension of conformity assessment bodies

1. The following procedure shall apply for the recognition of conformity assessment bodies in relation to the requirements set out in the relevant Chapters of Annex 1:

(a) a Party wishing to have recognised any conformity assessment body shall notify the other Party in writing of its proposal, to that effect, adding the appropriate information to its request;

(b) if the other Party agrees to the proposal or raises no objection within 60 days of the notification of the proposal, the conformity assessment body shall be considered to be a recognised conformity assessment body under the terms of Article 5;

(c) if the other Party raises objections in writing within that 60-day period, Article 8 shall apply.

2. A Party can withdraw or suspend the recognition or remove the suspension of recognition of a conformity assessment body under its jurisdiction. The Party concerned shall immediately notify the other Party of its decision in writing, together with the date of such decision. The withdrawal, suspension, or removal of suspension shall take effect at that date. Such withdrawal or suspension shall be indicated in the common list of recognised conformity assessment bodies referred to in Annex 1.

3. A Party can propose that the scope of activity of a recognised conformity assessment body under its jurisdiction be amended. For scope extensions and scope reductions the procedures provided for in Article 11(1) and (2) respectively shall apply.

4. A Party can, in exceptional circumstances, contest the technical competence of a recognised conformity assessment body under the jurisdiction of the other Party. In this case Article 8 shall apply.

5. Reports, certificates, authorisation and conformity marks issued by a conformity assessment body after the date at which its recognition has been withdrawn or suspended need not be recognised by the Parties. Reports, certificates, authorisations and conformity marks issued by a conformity assessment body before the date its recognition has been withdrawn shall continue to be recognised by the Parties unless the responsible designating authority has limited or cancelled their validity. The Party under whose jurisdiction the responsible designating authority is operating shall notify the other Party in writing of any such changes relating to a limitation or cancellation of validity.

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Article 12

Information exchange

1. The Parties shall exchange all relevant information regarding implementation and application of the legislative, regulatory and administrative provisions listed in Annex 1.

2. Each Party shall inform the other Party of the changes it intends to make to the legislative, regulatory and administrative provisions relating to the subject matter of this Agreement and shall notify ►M8 in writing ◄ the other Party of the new provisions at least 60 days before their entry into force.

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2a. Each Party shall notify changes to its designating authorities and competent authorities to the other Party in writing.

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3. Where the legislation of one of the Parties stipulates that a specific item of information must be made available to the competent authority by a person established in its territory, that authority may also approach the competent authority of the other Party or enter into direct contact with the manufacturer or, if appropriate, the latter's agent in the territory of the other Party, in order to obtain that information.

4. Each Party shall immediately notify the other Party of safeguard measures taken in its territory.

Article 13

Confidentiality

Representatives, experts and other agents of the Parties shall be required, even after their duties have ceased, not to disclose information acquired under this Agreement which is of the kind covered by the obligation of professional secrecy. This information may not be used for purposes other than those envisaged by this Agreement.

Article 14

Dispute settlement

Each Party may refer any dispute relating to the interpretation or application of this Agreement to the Committee. The Committee shall endeavour to settle the dispute, and must be supplied with any information which may facilitate a thorough examination of the situation with a view to finding an acceptable solution. For that purpose, the Committee shall consider every possible means of maintaining the smooth functioning of this Agreement.

Article 15

Agreements with third countries

The Parties hereby agree that mutual recognition agreements concluded by either Party with a country that is not party to this Agreement shall in no circumstances entail an obligation upon the other Party in terms of the acceptance of manufacturer's declarations of conformity as well as of reports, certificates, authorisations and marks issued by conformity assessment bodies in that third country, unless there is an explicit agreement between the Parties.

Article 16

Annexes

The Annexes to this Agreement shall form an integral part thereof.

Article 17

Territorial application

This Agreement shall apply, as regards the Community, to the territories in which the Treaty establishing the European Community is applied under the conditions laid down in that Treaty, on the one hand, and to the territory of Switzerland, on the other.

Article 18

Revision

1. If a Party wishes to have this Agreement revised, it shall inform the Committee. Modifications to this Agreement shall enter into force after the respective internal procedures have been completed.

2. The Committee may modify Annexes 1 and 2 to this Agreement on a proposal from one of the Parties.

Article 19

Suspension

Where a Party establishes that the other Party is failing to comply with the conditions of this Agreement, it may, after consulting the Committee, suspend application of Annex 1 in full or in part.

Article 20

Acquired rights

The Parties shall continue to recognise reports, certificates, authorisations and conformity marks and manufacturers' declarations of conformity issued in accordance with, and prior to the expiry of, this Agreement, provided that the request for conformity evaluation to be started was made before the notice of non-renewal or denunciation was given.

Article 21

Entry into force and duration

1. This Agreement shall be ratified or approved by the Parties in accordance with their own procedures. It shall enter into force on the first day of the second month following the last notification of deposit of the instruments for ratification or approval of all the following seven agreements:

Agreement on the mutual recognition in relation to conformity assessment

Agreement on the free movement of persons

Agreement on air transport

Agreement on the carriage of goods and passengers by rail and road

Agreement on trade in agricultural products

Agreement on certain aspects of public procurement

Agreement on scientific and technical cooperation.

2. This Agreement shall be concluded for an initial period of seven years. It shall be tacitly extended, unless the Community or Switzerland notifies the other Party to the contrary before the expiry of that period. Where such notification is given, the provisions of paragraph 4 shall apply.

3. The Community or Switzerland may denounce this Agreement by notifying the other Party. Where such notification is given, the provisions of paragraph 4 shall apply.

4. The seven agreements referred to in paragraph 1 shall cease to apply six months after receipt of the non-renewal notice described in paragraph 2 or the denunciation notice described in paragraph 3.

Hecho en Luxemburgo, el veintiuno de junio de mil novecientos noventa y nueve. El presente Acuerdo se establecerá por duplicado en lenguas alemana, danesa, española, finesa, francesa, griega, inglesa, italiana, neerlandesa, portuguesa y sueca y cada uno de estos textos será auténtico.

Udfærdiget i Luxembourg, den enogtyvende juni nitten hundrede og nioghalvfems i to eksemplarer på dansk, engelsk, finsk, fransk, græsk, italiensk, nederlandsk, portugisisk, spansk, svensk og tysk, idet hver af disse tekster har samme gyldighed.

Geschehen zu Luxemburg am einundzwanzigsten Juni neunzehnhundertneunundneunzig in zwei Urschriften in dänischer, deutscher, englischer, finnischer, französischer, griechischer, italienischer, niederländischer, portugiesischer, schwedischer und spanischer Sprache, wobei jeder Wortlaut gleichermaßen verbindlich ist.

Έγινε στο Λουξεμβούργο, στις είκοσι μία Ιουνίου χίλια εννιακόσια ενενήντα εννέα. Η παρούδα συμφωνία καταρτίζεται εις διπλούν στα αγγλικά, τα γαλλικά, τα γερμανικά, τα δανικά, τα ελληνικά, τα ισπανικά, τα ιταλικά, τα ολλανδικά, τα πορτογαλικά, τα σουηδικά και τα φινλανδικά, καθένα από τα κείμενα αυτά είναι αυθεντικό.

Done at Luxembourg on the twenty-first day of June in the year one thousand and ninety-nine. This Agreement is drawn up in duplicate in the Danish, Dutch, English, Finnish, French, German, Greek, Italian, Portuguese, Spanish and Swedish languages, each text being equally authentic.

Fait à Luxembourg, le vingt-et-un juin mil neuf cent quatre-vingt dix-neuf, en double exemplaire, en langues allemande, anglaise, danoise, espagnole, finnoise, française, grecque, italienne, néerlandaise, portugaise et suédoise, chacun de ces textes faisant également foi.

Fatto a Lussemburgo, addì ventuno giugno millenovecentonovantanove, in due copie nelle lingue danese, finlandese, francese, greco, inglese, italiano, olandese, portoghese, spagnolo, svedese e tedesco; tutte facenti ugualmente fede.

Gedaan te Luxemburg, de eenentwintigste juni negentienhonderd negenennegentig, in tweevoud in de Deense, de Duitse, de Engelse, de Finse, de Franse, de Griekse, de Italiaanse, de Nederlandse, de Portugese, de Spaanse en de Zweedse taal, zijnde alle teksten gelijkelijk authentiek.

Feito em Luxemburgo, em vinte e um de Junho de mil novecentos e noventa e nove, em dois exemplares em língua alemã, inglesa, dinamarquesa, espanhola, finlandesa, francesa, grega, italiana, neerlandesa, portuguesa e sueca, todas as versões fazendo igualmente fé.

Tehty Luxemburgissa kahdentenakymmenentenäensimmäisenä päivänä kesäkuuta vuonna tuhatyhdeksänsataayhdeksänkymmentäyhdeksän kahtena kappaleena englannin, espanjan, hollannin, italian, kreikan, portugalin, ranskan, ruotsin, saksan, suomen ja tanskan kielellä, ja jokainen teksti on yhtä todistusvoimainen.

Utfärdat i Luxemburg den tjugoförsta juni nittonhundranittionio i två exemplar på det danska, engelska, finska, franska, grekiska, italienska, nederländska, portugisiska, spanska, svenska och tyska språket, vilka samtliga texter är lika giltiga.

Por la Comunidad Europea

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft

Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Voor de Europese Gemeenschap

Pela Comunidade Europeia

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Por la Confederación Suiza

For Det Schweiziske Edsforbund

Für die Schweizerische Eidgenossenschaft

Για την Ελβετική Συνομοσπονδία

For the Swiss Confederation

Pour la Confédération suisse

Per la Confederazione svizzera

Voor de Zwitserse Bondsstaat

Pela Confederação Suíça

Sveitsin valaliiton puolesta

På Schweiziska edsförbundets vägnar

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ANNEX 1

PRODUCT SECTORS

This Annex is divided up into the following Chapters by sector: Chapter 1 Machinery Chapter 2 Personal protective equipment Chapter 3 Toys Chapter 4 Medical devices Chapter 5 Gas appliances and boilers Chapter 6 Pressure vessels Chapter 7 Radio equipment and telecommunications terminal equipment Chapter 8 Equipment and protective systems intended for use in potentially explosive atmosphere Chapter 9 Electrical equipment and electromagnetic compatibility Chapter 10 Construction plant and equipment Chapter 11 Measuring instruments and prepackages Chapter 12 Motor vehicles Chapter 13 Agricultural or forestry tractors Chapter 14 Good laboratory practice (GLP) Chapter 15 Medicinal products, GMP Inspection and Batch Certification Chapter 16 Construction Products Chapter 17 Lifts Chapter 18 Biocidal Products Chapter 19 Cableway installations Chapter 20 Explosives for civil use

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CHAPTER 1

MACHINERY

Section I

Legislative, regulatory and administrative provisions







Provisions covered by Article 1(2) ▼M16 European Union 1. Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157, 9.6.2006, p. 24), as last amended by Directive 2009/127/EC of the European Parliament and of the Council of 21 October 2009 amending Directive 2006/42/EC with regard to machinery for pesticide application (OJ L 310, 25.11.2009, p. 29) ▼M15 Switzerland 100. Federal Law of 12 June 2009 on product safety (RO 2010 2573) 101. Ordinance of 19 May 2010 on product safety (RO 2010 2583) 102. Ordinance of 2 April 2008 on the safety of machinery (RO 2008 1785), as last amended on 20 April 2011 (RO 2011 1755) ▼M12

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Annex XI to Directive 2006/42/EC.

Section V

Supplementary provisions

1. Second-hand machinery

The legislative, regulatory and administrative provisions listed in section I shall not apply to second-hand machinery.

The principle contained in Article 1(2) of this Agreement shall apply, however, to machinery legally placed on the market and/or put into service in one of the Parties and exported as second-hand machinery to the market of the other Party.

The other provisions relating to second-hand machinery, e.g. those relating to safety in the place of work in force in the importing state, shall remain applicable.

2. Information exchange

In accordance with Article 9 of this Agreement, the Parties shall exchange information needed to ensure a proper implementation of this chapter.

The Parties hereby undertake to forward all relevant technical documents at the request of the authorities of the other Party.

3. Person named in the declaration of conformity of machines, authorised to compile the technical file

The declaration of conformity of the machinery must contain the name and address of the person authorised to compile the technical file, who must be established in the respective Parties’ territory.

The Parties shall mutually recognise this person. The manufacturer, his authorised representatives or, where neither of these is present, the person responsible for placing products on the market of one Party, shall not be obliged to designate a person, who is responsible for compiling the technical file, in the territory of the other Party.

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CHAPTER 2

PERSONAL PROTECTIVE EQUIPMENT

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)







European Union 1. Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51). Switzerland 100. Federal Law of 12 June 2009 on product safety (RO 2010 2573) 101. Ordinance of 19 May 2010 on product safety (RO 2010 2583) as last amended on 25 October 2017 (RO 2017 5865) 102. Ordinance of 25 October 2017 on the safety of personal protective equipment (RO 2017 5859) 103. Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261)

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter V of Regulation (EU) 2016/425.

Section V

Supplementary provisions

1. Economic operators

1.1. Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

(a) for the purpose of the obligations in Articles 8(6) and 10(3) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted. In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;

(b) for the purpose of the obligations in Article 8(3) and 10(8) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keeps the technical documentation and the EU declaration of conformity for 10 years after the PPE has been placed on the market in either the European Union or Switzerland. In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keeps a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensures that the technical documentation can be made available to those authorities upon request for 10 years after the PPE has been placed on the market in either the European Union or Switzerland;

(c) for the purpose of the obligations in Article 8(4), second subparagraph, and 10(6) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.

1.2. Authorised representative

For the purpose of the obligation in Article 9(2) of Regulation (EU) 2016/425 and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 9(1) of Regulation (EU) 2016/425 or the corresponding Swiss provisions.

1.3. Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a PPE with the legislation in section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the PPE.

2. Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 35 of Regulation (EU) 2016/425.

3. Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 36 of Regulation (EU) 2016/425, directly or by means of designated representatives.

4. Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5. Procedure for dealing with PPE presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a PPE covered by this Chapter presents a risk to the health or safety of persons covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

— the results of the evaluation and of the actions which they have required the economic operator to take;

— where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the PPE being made available on their national market, to withdraw the PPE from that market or to recall it.

This information shall include all available details, in particular the data necessary for the identification of the non-compliant PPE, their origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

— failure of the PPE to meet requirements relating to the health or safety of persons referred to in the legislation in section I, or

— shortcomings in the harmonised standards referred to in the legislation in Section I.

Switzerland or Member States shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the PPE concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the PPE concerned, such as withdrawal of the PPE from their market, without delay.

6. Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure is considered:

— justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant PPE is withdrawn from their markets, and shall inform the Commission accordingly;

— unjustified, the Member State concerned or Switzerland shall withdraw that measure.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7. Compliant PPE which nevertheless present a risk

Where a Member State or Switzerland finds that, although a PPE that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the PPE concerned, the origin and the supply chain of the PPE, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and, where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8. Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.

Where the Committee considers that the measure is:

(a) justified, the Parties shall take the measures necessary to ensure that the PPE is withdrawn from their market;

(b) unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.

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CHAPTER 3

TOYS

Section I

Legislative, regulatory and administrative provisions







Provisions covered by Article 1(2) European Union 1. Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1, as last amended by Commission Directive (EU) 2017/898 (OJ L 138, 25.5.2017, p. 128) (hereinafter referred to as ‘Directive 2009/48/EC’) Switzerland 100. Federal Law of 20 June 2014 on foodstuffs and commodities (RO 2017 249) 101. Ordinance of 16 December 2016 on foodstuffs and commodities (RO 2017 283) as last amended on 2 May 2017 (RO 2017 2695) 102. Ordinance of the Federal Department of Home Affairs (FDHA) of 15 August 2012 on the safety of toys (RO 2012 4717) as last amended on 1 May 2017 (RO 2017 1525) 103. Ordinance of the FDHA of 16 December 2016 on the enforcement of foodstuff legislation (RO 2017 359 104. Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 20 April 2016 (RO 2016 261)

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and with Article 24 of Directive 2009/48/EC.

Section V

Supplementary provisions

1. Exchange of information concerning the certificate of conformity and the technical documentation

The market surveillance authorities of the Member States or Switzerland may, on reasoned request, ask for the technical documentation, or a translation of parts thereof from a manufacturer based in the territory of either Switzerland or a Member State. The market surveillance authorities of the Member states and Switzerland may request from a Swiss or a European Union-based manufacturer the relevant part of the technical documentation into an official language of the requesting authority or in English.

When a market surveillance authority requests the technical documentation or a translation of parts thereof from a manufacturer, it may set a deadline for receipt of 30 days, unless a shorter deadline is justified in the case of serious and immediate risk.

If the manufacturer based on the territory of either Switzerland or a Member State does not comply with this provision, the market surveillance authority may require it to have a test performed by a designated body at its own expense within a specified period in order to verify compliance with the harmonised standards and essential requirements.

2. Information requests to designated bodies

The market surveillance authorities of the Member States and of Switzerland may request a designated body in Switzerland or in a Member State to provide information relating to any type examination certificate which that body has issued or withdrawn, or which relates to any refusal to issue such a certificate, including the test reports and technical documentation.

3. Information obligations of designated bodies

In accordance with Article 36(2) of Directive 2009/48/EC, designated bodies shall provide the other bodies designated under this Agreement which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.

4. Exchange of experience

Swiss national authorities may take part in the exchange of experience between the Member States’ national authorities responsible for the notification procedure referred to in Article 37 of Directive 2009/48/EC.

5. Coordination of designated bodies

Designated Swiss conformity assessment bodies may take part in the coordination and cooperation mechanisms and sectoral groups or groups of notified bodies provided for in Article 38 of Directive 2009/48/EC, directly or by means of designated representatives.

6. Market access

Importers based in the European union or Switzerland shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the toy or, when that is not possible, on its packaging or in a document accompanying the toy.

The Parties mutually recognise this indication of the coordinates of the manufacturer and importer, registered trade name or registered trade mark and the address at which they can be contacted, which must be mentioned as above. For the purpose of this specific obligation, ‘importer’ shall mean any natural or legal person established within the territory of either the European Union or Switzerland who places a toy from a third country on the European Union or on the Swiss market.

7. Harmonised standards

Switzerland recognises harmonised standards conferring a presumption of conformity with the legislation referred to in Section 1 of this Chapter. Where Switzerland considers that compliance with a harmonised standard does not entirely satisfy the requirements which are set out in the legislation listed in Section I, it shall bring the matter before the Committee and give its reasons.

The Committee shall consider the case and may ask the European Union to act in accordance with the procedure provided for in Article 14 of Directive 2009/48/EC. The Committee shall be informed of the result of the procedure.

8. Procedure for dealing with toys presenting a non-compliance that is not restricted to their national territory ( 1 )

Pursuant to Article 12(4) of this Agreement, in cases where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reasons to believe that a toy covered by Section I of the present Chapter presents a risk to the health or safety of persons, and if they consider that the non-compliance is not restricted to their national territory, they shall inform each other and the European Commission immediately of:

— the results of the evaluation they have carried out and of the actions which they have required the relevant economic operator to take;

— provisional measures taken to prohibit or restrict the toy being made available on their national market, to withdraw the toy from that market or to recall it when the relevant economic operator does not take adequate corrective action. This includes the details set out in Article 42(5) of Directive 2009/48/EC.

The market surveillance authorities of the Member States or Switzerland other than the one initiating this procedure shall inform without delay the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the toy concerned.

The Parties shall ensure that appropriate restrictive measures in respect of the toy concerned, such as withdrawal of the toy from their market, are taken without delay.

9. Safeguard procedure in case of objections against national measures

Should it disagree with the notified national measure, Switzerland or a Member State shall inform the European Commission of its objections.

Where, on completion of the procedure set out in paragraph 8 above, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State respectively, or where the European Commission considers a national measure to be non-compliant with the legislation referred to in this Chapter, the European Commission shall without delay enter into consultation with the Member States, Switzerland and the relevant economic operator or operators and shall evaluate the national measure in order to determine if it is justified or not.

In case of an agreement between the Parties on the results of their investigations, the Member States and Switzerland shall take the measures necessary to ensure that appropriate restrictive measures are taken in respect of the toy concerned, such as the withdrawal of the toy from their market, without delay.

In case of a disagreement between the Parties on the results of their investigations, the issue will be forwarded to the Committee, which may decide to have an expert study carried out.

Where the Committee considers that the measure is:

(a) unjustified, the national authority of the Member State or Switzerland which took the measure shall withdraw it;

(b) justified, the Parties shall take the measures necessary to ensure that the non-compliant toy is withdrawn from their market.

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CHAPTER 4

MEDICAL DEVICES

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)







European Union 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, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1). 2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) 3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as last amended by Regulation (EC) No 1882/2003 of the European Parliament and the Council of 29 September 2003 (OJ L 284, 31.10.2003, p. 1) and corrected by Corrigenda (OJ L 22, 29.1.1999, p. 75 and OJ L 6, 10.1.2002, p. 70). 4. Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16.5.2002, p. 17). 5. Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, p. 43). 6. Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 22, 9.8.2012, p. 3). 7. Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, p. 41). 8. Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation (OJ L 379, 28.12.2006, p. 98). 9. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L 247, 21.9.2007, p. 21). 10. Commission Decision 2011/869/EU of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (OJ L 341, 22.12.2011, p. 63). 11. Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and the Council on in-vitro diagnostic medical devices (OJ L 341, 22.12.2011, p. 50). 12. Directive 2011/65/EU of the European Parliament and the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88). 13. Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed) (OJ L 102, 23.4.2010, p. 45). 14. Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, p. 28). 15. Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p. 8). 16. Chapter IV and Annex VII of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 17. Chapter IV and Annex VII of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). Switzerland 100. Federal Law of 15 December 2000 on medicinal products and medical devices (RO 2001 2790), as last amended 1 January 2014 (RO 2013 4137) 101. Federal Law of 24 June 1902 concerning the electrical weak and heavy current installations (RO 19 252 et RS 4 798), as last amended on 20 March 2008 (RO 2008 3437) 102. Federal Law of 9 June 1977 on metrology (RO 1977 2394), as last amended on 17 June 2011 (RO 2012 6235) 103. Federal law of 22 March 1991 on radiation protection (RO 1994 1933), as last amended on 10 December 2004 (RO 2004 5391) 104. Ordinance of 17 October 2001 on medical devices (RO 2001 3487), as last amended on 25 October 2017 (RO 2017 5935) 105. Ordinance of 18 April 2007 on import, transit and export of animals and animal products (RO 2007 1847), as last amended on 4 September 2013 (RO 2013 3041) 106. Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261) 107. Federal Act on Data Protection of 19 June 1992 (RO 1992 1945), as last amended on 30 September 2011 (RO 2013 3215)

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies under this Chapter, the designating authorities shall:

— comply with the general principles contained in Annex 2 to this Agreement,

— as laid down in Regulation (EU) No 920/2013, comply with the assessment criteria set out in Annex XI to Directive 93/42/EEC, in Annex 8 to Directive 90/385/EEC and in Annex IX to Directive 98/79/EC, and

— comply with the assessment criteria set out in Chapter IV and Annex VII of Regulation (EU) 2017/745 and of Regulation (EU) 2017/746.

The Parties shall make available assessors for the pool established under Regulation (EC) No 920/2013, Article 40 of Regulation (EU) 2017/745 and Article 36 of Regulation (EU) 2017/746. The designating authorities of the Parties shall cooperate for the assessment of notified bodies in line with Article 39 of Regulation (EU) 2017/745 and Article 35 of Regulation (EU) 2017/746. They shall participate in peer reviews pursuant to Article 48 of Regulation (EU) 2017/745 and Article 44 of Regulation (EU) 2017/746.

Section V

Supplementary provisions

1. Registration of the person responsible for placing devices on the market

Any manufacturer or his authorised representative who places on the market of one of the Parties the medical devices referred to in Article 14 of Directive 93/42/EEC or Article 10 of Directive 98/79/EC shall inform the competent authorities of the Party in which he has his registered place of business of the particulars referred to in those Articles. The Parties shall reciprocally recognise that registration. The manufacturer shall not be obliged to designate a person responsible for placing devices on the market established in the territory of the other Party.

2. Labelling of medical devices

Manufacturers of both Parties shall indicate their name or trade name and address on the label of medical devices specified in Annex 1, point 13.3(a) to Directive 93/42/EEC and in vitro diagnostic medical devices specified in Annex 1, point 8.4(a), to Directive 98/79/EC. They shall not be obliged to indicate the name and address of the person responsible for placing the device on the market, of the representative or of the importer established within the territory of the other Party on the label, outer packaging or instructions for use.

For devices imported from third countries, in view of their distribution in the Union and Switzerland, the label, or the outer packaging, or instructions for use, shall contain the name and address of the single authorised representative of the manufacturer established within the Union or Switzerland, as appropriate.

3. Information exchange and cooperation

In accordance with Article 9 of the Agreement,

— the Parties shall in particular exchange the information referred to in Article 8 of Directive 90/385/EEC, Article 10 of Directive 93/42/EEC, Article 11 of Directive 98/79/EC and Article 3 of Regulation (EU) No 920/2013,

— the Parties shall in particular cooperate according to Articles 102 and 103 of Regulation (EC) No 2017/745 and Articles 97 and 98 of Regulation (EU) 2017/746.

— Switzerland may submit the application of expert laboratories for designation by the Commission in accordance with Article 106 of Regulation (EU) 2017/745 or the application of reference laboratories for designation by the Commission in accordance with Article 100 of Regulation (EU) 2017/746.

4. European databases

The competent Swiss authorities shall have access to the European databases established under Article 12 of Directive 98/79/EC, Article 14a of Directive 93/42/EEC, Article 3 of Regulation (EU) No 920/2013, Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746. They shall transmit to the Commission and/or body responsible for managing the databases the data provided for in those Articles collected in Switzerland for entry into the European databases.

5. Transitional provisions

By way of derogation to the legislation in Section I, devices which comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may be placed on the market of both Parties respectively.

By way of derogation to the legislation in Section I, notified bodies which are designated and notified in accordance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may carry out assessment procedures laid down in these regulations and issue certificates in accordance with these Regulations. Such certificates shall be recognized by the Parties.

CHAPTER 5

GAS APPLIANCES AND BOILERS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(1)







European Union 1. Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17), as subsequently amended Switzerland 100. Ordinance of 16 December 1985 on Air Pollution Control (OAPC) (Annex 3 and 4) (RS 814.318.142.1, as subsequently amended

Provisions covered by Article 1(2)







European Union 1. Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99). Switzerland 100. Federal Law of 12 June 2009 on product safety (RO 2010 2573) 101. Ordinance of 19 May 2010 on product safety (RO 2010 2583), as last amended on 25 October 2017 (RO 2017 5865) 102. Ordinance of 25 October 2017 on gas appliances (RO 2017 5865) 103. Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261)

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter IV of Regulation (EU) 2016/426.

Section V

Supplementary provisions

1. Economic operators

1.1. Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

(a) for the purpose of the obligations in Articles 7(6) and 9(3) of Regulation (EU) 2016/426 and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark, and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted. In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;

(b) for the purpose of the obligations in Article 7(3) and 9(8) of Regulation (EU) 2016/426 and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keeps the technical documentation and the EU declaration of conformity for 10 years after the appliance or the fitting has been placed on the market in either the European Union or Switzerland. In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keeps a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensures that the technical documentation can be made available to those authorities upon request for 10 years after the appliance or the fitting has been placed on the market in either the European Union or Switzerland;

(c) for the purpose of the obligations in Article 7(4), second subparagraph, and 9(6) of Regulation (EU) 2016/426 and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.

1.2. Authorised representative

For the purpose of the obligation in Article 8(2) of Regulation (EU) 2016/426 and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 8(1) of Regulation (EU) 2016/426 or the corresponding Swiss provisions.

1.3. Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of an appliance or fitting with the legislation in section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the appliance or the fitting.

2. Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 34 of Regulation (EU) 2016/426.

3. Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 35 of Regulation (EU) 2016/426, directly or by means of designated representatives.

4. Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5. Procedure for dealing with appliances or fittings presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that an appliance or fitting covered by this Chapter presents a risk to the health or safety of persons or to domestic animals or property covered by the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

— the results of the evaluation and of the actions which they have required the economic operator to take;

— where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the appliances or fittings being made available on their national market, to withdraw the appliance or fitting from that market or to recall it.

This information shall include all available details, in particular the data necessary for the identification of the non-compliant appliance or fitting, their origin, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

— failure of the appliance or fitting to meet requirements relating to the health or safety of persons or to domestic animals or property referred to in the legislation in section I, or

— shortcomings in the harmonised standards referred to in the legislation in Section I.

Switzerland or Member States shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the appliance or fitting concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the appliance or fitting concerned, such as withdrawal of appliance or fitting from their market, without delay.

6. Safeguard procedure in case of objections against national measures

Should Switzerland or a Member State disagree with the national measure in paragraph 5, it shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators. It shall evaluate the national measure, in order to determine whether the national measure is justified or not.

If the national measure relating to an appliance or fitting is considered:

— justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant appliance or fitting is withdrawn from their markets, and shall inform the Commission accordingly;

— unjustified, the Member State concerned or Switzerland shall withdraw that measure.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7. Compliant appliances or fittings which nevertheless present a risk

Where a Member State or Switzerland finds that, although an appliance or fitting that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to domestic animals or property, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the appliance or fitting concerned, the origin and the supply chain of the appliance or fitting, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and, where necessary, propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8. Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee established under Article 10 of this Agreement, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.

Where the Committee considers that the measure is:

(a) justified, the Parties shall take the measures necessary to ensure that the appliance or fitting is withdrawn from their market;

(b) unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.

9. Information exchange

In accordance with Article 12 of this Agreement, the Parties shall exchange information on the types of gas and the corresponding supply pressures of gaseous fuels used on their territory referred to in Annex II of Regulation (EU) 2016/426. Further Switzerland shall inform about the changes thereof within six months after the announcement of the envisaged changes. The European Union shall inform about the changes thereof within six months after it received the notification by a Member State.

▼M18

CHAPTER 6

PRESSURE VESSELS

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)







European Union 1. Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45) 2. Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164) 3. Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1), hereinafter referred to as ‘Directive 2010/35/EU’ 4. Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13) Switzerland 100. Federal Law of 12 June 2009 on product safety (RO 2010 2573) 101. Ordinance of 19 May 2010 on product safety (RO 2010 2583), as last amended on 15 June 2012 (RO 2012 3631) 102. Ordinance of 25 November 2015 on the safety of simple pressure vessels (RO 2016 227) 103. Ordinance of 25 November 2015 on the safety of pressure equipment (RO 2016 233) 104. Ordinance of 31 October 2012 relating to the placing on the market of dangerous goods receptacles and the market surveillance (RO 2012 6607) 105. Ordinance of 29 November 2002 on the transport of dangerous goods by road (RO 2002 4212), as last amended on 31 October 2012 (RO 2012 6535 and 6537) 106. Ordinance of 31 October 2012 on the transport of dangerous goods by rail and cableway (RO 2012 6541) 107. Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261)

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, the designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter 4 of Directive 2014/29/EU, Chapter 4 of Directive 2014/68/EU or Chapter 4 of Directive 2010/35/EU.

Section V

Supplementary provisions

1. Economic operators

1.1. Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

(a) for the purpose of the obligations in Article 6(3) of Directive 2010/35/EU, respectively Articles 6(6) and 8(3) of Directive 2014/29/EU, or Articles 6(6) and 8(3) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted. In cases where the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;

(b) for the purpose of the obligations in Articles 4(3) and 6(6) of Directive 2010/35/EU, respectively Articles 6(3) and 8(8) of Directive 2014/29/EU or Articles 6(3) and 8(8) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the product has been placed on the market in either the European Union or Switzerland. In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity or, where applicable, the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the product has been placed on the market in either the European Union or Switzerland;

(c) for the purpose of the obligations in Articles 6(4), second subparagraph, and 8(6) of Directive 2014/29/EU or Articles 6(4), second subparagraph, and 8(6) of Directive 2014/68/EU and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.

1.2. Authorised representative

For the purpose of the obligation in Article 5(2) of Directive 2010/35/EU, respectively Article 7(2) of Directive 2014/29/EU, or Article 7(2) of Directive 2014/68/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 5(1) of Directive 2010/35/EU, respectively Article 7(1) of Directive 2014/29/EU, or Article 7(1) of Directive 2014/68/EU or the corresponding Swiss provisions.

1.3. Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of a product with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the product.

2. Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 28 of Directive 2010/35/EU, Article 32 of Directive 2014/29/EU and Article 37 of Directive 2014/68/EU.

3. Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 29 of Directive 2010/35/EU, Article 33 of Directive 2014/29/EU and Article 38 of Directive 2014/68/EU, directly or by means of designated representatives.

4. Mutual assistance of market surveillance authorities

Pursuant to Article 9(1) of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

5. Procedure for dealing with products presenting a risk not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have taken action or have sufficient reason to believe that a product covered by this chapter presents a risk to the health or safety of persons or to other aspects of public interest protection referred to in the relevant legislation in Section I of this Chapter and if they consider that non-compliance is not restricted to their national territory, they shall inform the European Commission, the other Member States and Switzerland without delay of:

— the results of the evaluation and of the actions which they have required the economic operator to take,

— where the relevant economic operator does not take adequate corrective action, all appropriate provisional measures taken to prohibit or restrict the product being made available on their national market, to withdraw the product from that market or to recall it.

This information shall include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, it shall be indicated whether the non-compliance is due to either:

— failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection in the legislation in Section I, or

— shortcomings in the harmonised standards referred to in the legislation in Section I.

Switzerland or Member States other than the Member State initiating the procedure shall without delay inform the European Commission and the other national authorities of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned.

Member States and Switzerland shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.

6. Safeguard procedure in case of objections against national measures

Should it disagree with the notified national measure in paragraph 5, Switzerland or a Member State shall inform the European Commission of its objections within three months of the receipt of the information.

Where, on completion of the procedure set out in paragraph 5, objections are raised by a Member State or Switzerland against a measure taken by Switzerland or a Member State or where the Commission considers a national measure to be contrary to the relevant legislation referred to in Section I, the European Commission shall without delay enter into consultation with the Member States and Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measure, in order to determine whether the national measure is justified or not. If the national measure is considered:

— justified, all Member States and Switzerland shall take the measures necessary to ensure that the non-compliant product is withdrawn from their markets, and shall inform the Commission accordingly,

— unjustified, the Member State concerned or Switzerland shall withdraw that measure.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

7. Compliant products which nevertheless present a risk

Where a Member State or Switzerland finds that, although a product that an economic operator has made available on the EU and on the Swiss market is in compliance with the legislation referred to in Section I of this Chapter, it presents a risk for the health or safety of persons or to other aspects of public interest protection referred to in the relevant legislation in Section I of this Chapter, it shall take all appropriate measures and immediately inform the Commission, other Member States and Switzerland. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

The Commission shall without delay enter into consultation with the Member States, Switzerland, and via the Swiss authorities the relevant economic operator or operators, and shall evaluate the national measures taken, in order to determine whether the national measure is justified or not, and where necessary propose appropriate measures.

A Party may forward the issue to the Committee established under Article 10 of this Agreement, pursuant to paragraph 8.

8. Safeguard clause in case of remaining disagreement between the Parties

In case of a disagreement between the Parties on measures at stake in paragraphs 6 and 7 above, the issue will be forwarded to the Committee, which will decide on an appropriate course of action, including the possibility to have an expert study carried out.

Where the Committee considers that the measure is:

(a) justified, the Parties shall take the measures necessary to ensure that the product is withdrawn from their market;

(b) unjustified, the national authority of the Member State or Switzerland shall withdraw the measure.

CHAPTER 7

RADIO EQUIPMENT AND TELECOMMUNICATIONS TERMINAL EQUIPMENT

Section I

Legislative, regulatory and administrative provisions

Provisions covered by Article 1(2)







European Union 1. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62) 2. Commission Decision 2000/299/EC of 6 April 2000 establishing the initial classification of radio equipment and telecommunications terminal equipment and associated identifiers (OJ L 97, 19.4.2000, p. 13) (1) 3. Commission Decision 2000/637/EC of 22 September 2000 on the application of Article 3(3)(e) of Directive 1999/5/EC to radio equipment covered by the regional arrangement concerning radiotelephone service on inland waterways (OJ L 269, 21.10.2000, p. 50) 4. Commission Decision 2001/148/EC of 21 February 2001 on the application of Article 3(3)(e) of Directive 1999/5/EC to avalanche beacons (OJ L 55, 24.2.2001, p. 65) 5. Commission Decision 2005/53/EC of 25 January 2005 on the application of Article 3(3)(e) of Directive 1999/5/EC of the European Parliament and of the Council to radio equipment intended to participate in the Automatic Identification System (AIS) (OJ L 22, 26.1.2005, p. 14) 6. Commission Decision 2005/631/EC of 29 August 2005 concerning essential requirements as referred to in Directive 1999/5/EC of the European Parliament and of the Council ensuring access of Cospas-Sarsat locator beacons to emergency services (OJ L 225, 31.8.2005, p. 28) 7. Commission Decision 2013/638/EU of 12 August 2013 on essential requirements relating to marine radio communication equipment which is intended to be used on non-SOLAS vessels and to participate in the Global Maritime Distress and Safety System (GMDSS) (OJ L 296, 7.11.2013, p. 22) 8. Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (recast) (OJ L 96, 29.3.2014, p. 357) (2) 9. Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast) (OJ L 96, 29.3.2014, p. 79) (2) Switzerland 100. Federal Law of 30 April 1997 on Telecommunications (LTC); (RO 1997 2187), as last amended on 12 June 2009 (RO 2010 2617) 101. Ordinance of 25 November 2015 on Telecommunications Equipment (OIT) (RO 2016 179) 102. Ordinance of 26 May 2016 of the Federal Office of Communications (OFCOM) on Telecommunications Equipment; (RO 2016 1673), as last amended on 15 June 2017(RO 2017 3201) 103. Ordinance of 17 June 1996 on the Swiss accreditation system and on the designation of test laboratories and conformity assessment bodies (RO 1996 1904), as last amended on 25 November 2015 (RO 2016 261) 104. Ordinance of 9 March 2007 on Telecommunication Services (RO 2007 945), as last amended on 5 November 2014 (RO 2014 4035) (1) The reference to the class identifier in Article 2 of Commission Decision 2000/299/EC does not apply. (2) Without prejudice to Chapter 9.

Section II

Conformity assessment bodies

The Committee established under Article 10 of this Agreement shall draw up and keep up to date, according to the procedure described in Article 11 of the Agreement, a list of the conformity assessment bodies.

Section III

Designating authorities

The Committee established under Article 10 of this Agreement shall draw up and keep up to date a list of the designating authorities notified by the Parties.

Section IV

Special rules relating to the designation of conformity assessment bodies

For the designation of conformity assessment bodies, designating authorities shall comply with the general principles contained in Annex 2 to this Agreement and the assessment criteria set out in Chapter IV of Directive 2014/53/EU.

Section V

Supplementary provisions

1. Amendments to legislative, regulatory and administrative provisions of Section I

Without prejudice to Article 12(2) of this Agreement, the European Union shall notify Switzerland of implementing and delegated acts of the Commission under Directive 2014/53/EU adopted after 13 June 2016 without delay after their publication in the Official Journal of the European Union.

Switzerland shall notify the European Union without delay of the relevant amendments of the Swiss legislation.

2. Economic operators

2.1. Specific obligations of economic operators pursuant to the legislation under Section I

Pursuant to the legislation under Section I, economic operators established in the EU or Switzerland are subject to equivalent obligations.

In order to avoid unnecessary duplication of obligations:

(a) for the purpose of the obligations in Articles 10(7) and 12(3) of Directive 2014/53/EU and the corresponding Swiss provisions, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the manufacturer established within the territory of either the European Union or Switzerland can be contacted. In cases where the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient to indicate the name, registered trade name or registered trade mark and the postal address at which the importer established within the territory of either the European Union or Switzerland can be contacted;

(b) for the purpose of the obligations in Articles 10(4) and 12(8) of Directive 2014/53/EU and the corresponding Swiss provisions, it shall be sufficient that the manufacturer established within the territory of either the European Union or Switzerland keep the technical documentation and the EU declaration of conformity or, where applicable, the attestation of conformity for 10 years after the radio equipment has been placed on the market in either the European Union or Switzerland. In case the manufacturer is not established within the territory of either the European Union or Switzerland, it shall be sufficient that the importer established within the territory of either the European Union or Switzerland keep a copy of the EU declaration of conformity or, where applicable, the attestation of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities upon request for 10 years after the radio equipment has been placed on the market in either the European Union or Switzerland;

(c) for the purpose of the obligations in Article 10(5), second subparagraph, and 12(6) of Directive 2014/53/EU and the corresponding Swiss provisions, it shall be sufficient that such obligations be fulfilled by the manufacturer established within the territory of either the European Union or Switzerland, or, in case the manufacturer is not established within the territory of either the European Union or Switzerland, by the importer established within the territory of either the European Union or Switzerland.

2.2. Provision of information on radio equipment and software by manufacturer

(a) Manufacturers shall ensure that radio equipment shall be so constructed that it can be operated in at least one Member State or Switzerland without infringing applicable requirements on the use of the radio spectrum. In cases of restrictions on putting into service or of requirements for authorisation of use of radio equipment, information on the packaging shall identify restrictions existing in Switzerland, Member States or geographical areas within their territory.

(b) For radio equipment within the scope of Article 4 of Directive 2014/53/EU and the corresponding Swiss legislation, manufacturers of radio equipment and of software allowing radio equipment to be used as intended shall, where required in the legislation under Section I, provide and continuously update the Member States, Switzerland and the Commission, with information on the compliance of intended combinations of radio equipment and software with the essential requirements set out in Directive 2014/53/EU and the corresponding Swiss legislation, in the form of a statement of compliance which includes the elements of the declaration of conformity.

(c) As from 12 June 2018, where required in the legislation under Section I, manufacturers shall, prior to placing on the Parties' markets radio equipment within categories designated by the European Commission as affected by a low level of compliance, register their types within the central system mentioned in Article 5 of Directive 2014/53/EU. The European Commission shall allocate to each registered radio equipment type a registration number, which manufacturers shall affix on radio equipment placed on the market.

The Parties shall exchange information on registered radio equipment types affected by a low level of compliance.

The Parties shall take into account information on compliance of radio equipment provided by Switzerland and Member States when designating categories of radio equipment affected by a low level of compliance.

2.3. Authorised representative

For the purpose of the obligation in Article 11(2) of Directive 2014/53/EU and the corresponding Swiss provisions, authorised representative shall mean any natural or legal person established within the European Union or Switzerland who has received a written mandate from a manufacturer to act on his behalf pursuant to Article 11(1) of Directive 2014/34/EU or the corresponding Swiss provisions.

2.4. Cooperation with market surveillance authorities

The competent national market surveillance authority of a Member State of the European Union or Switzerland may, on reasoned request, ask the relevant economic operators in the European Union and in Switzerland to provide all the information and documentation necessary to demonstrate the conformity of radio equipment with the legislation in Section I.

That authority may contact the economic operator established within the territory of the other Party either directly or with the assistance of the competent national market surveillance authority of the other Party. It may request manufacturers or, where applicable, authorised representatives and importers to provide the documentation in a language easily understood by that authority. It may request the economic operators to cooperate on any action taken to eliminate the risks posed by the radio equipment.

3. Assignment of radio equipment classes

Member States and Switzerland shall notify each other the interfaces they intend to regulate on their territory in cases foreseen under Article 8(1) of Directive 2014/53/EU. When establishing the equivalence of regulated radio interfaces and assigning a radio equipment class, the European Union shall take account of the radio interfaces regulated in Switzerland

4. Interfaces offered by public telecommunications network operators

The Parties shall inform each other of interfaces offered on their territory by public telecommunications network operators.

5. Application of essential requirements, putting into service and use

(a) When the Commission intends to adopt a requirement related to categories or classes of radio equipment pursuant to Articles 2(6), 3(3), 4(2), 5(2) of Directive 2014/53/EU, it shall consult Switzerland on the issue before submitting it formally to the Committee, unless a consultation took place with the Telecommunication Conformity Assessment and Market Surveillance Committee.

(b) Member States and Switzerland shall allow the putting into service and use of radio equipment if it complies with the legislation in Section I when it is properly installed, maintained and used for its intended purpose. They may only introduce additional requirements for the putting into service and/or use of radio equipment for reasons related to the effective and efficient use of the radio spectrum, to the avoidance of harmful interference, to the avoidance of electromagnetic disturbances or to public health.

6. Coordination of conformity assessment bodies

Swiss designated conformity assessment bodies may take part in the coordination and cooperation mechanisms provided for in Article 38 of Directive 2014/53/EU, directly or by means of designated representatives.

Conformity assessment bodies shall inform the other bodies recognised under this chapter concerning type examination certificates which they have refused, withdrawn, suspended or restricted, and upon request concerning certificates they have issued.

Conformity assessment bodies shall inform the Member States and Switzerland of type examination certificates issued and/or additions thereto, in those cases where harmonised standards have not been applied or not been fully applied. The Member States, Switzerland, the European Commission and the other bodies may, on request, obtain a copy of the type examination certificates and/or additions thereto, a copy of the technical documentation and the results of the examinations carried out.

7. Exchange of experience

Swiss designating authorities may take part in the exchange of experience between the Member States' national authorities referred to in Article 37 of Directive 2014/53/EU.

8. Telecommunication Conformity Assessment and Market Surveillance Committee

Switzerland may participate as observer in the Telecommunication Conformity Assessment and Market Surveillance Committee work and that of its sub-groups.

9. Cooperation between market surveillance authorities

Pursuant to Article 9 paragraph1 of the Agreement, the Parties shall ensure efficient cooperation and exchange of information between their market surveillance authorities. The market surveillance authorities of Member States and Switzerland shall cooperate and exchange information. They shall give each other assistance on an adequate scale by supplying information or documentation concerning economic operators based in a Member State or in Switzerland.

10. Objections to harmonised standards

Where Switzerland considers that compliance with a harmonised standard does not guarantee that the essential requirements of its legislation as listed in Section I will be fulfilled, it shall inform the Committee and give its reasons.

The Committee shall consider the case and may ask the European Commission to act in accordance with the procedure provided for in Article 11 of Regulation (EU) No 1025/2012 of the European Parliament and of the Council ( 2 ). The Committee shall be informed of the result of the procedure.

11. Procedure for dealing with equipment presenting a risk caused by non-compliance not restricted to the national territory

Pursuant to Article 12(4) of this Agreement, where the market surveillance authorities of a Member State or Switzerland have found that equipment covered by this chapter does not comply with requirements laid down in the legislation in Section I of this Chapter, and if they consider that non-compliance is not restricted to their national territory, they shall inform the