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Regulation (EC) No 765/2008 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance)

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Changes and effects yet to be applied to Chapter III Section 2:

Newidiadau ac effeithiau heb eu gweithredu eto ar yr eitem ddeddfwriaeth gyfan a’r darpariaethau cysylltiedig.

  • Ch. 3 Art. 27 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 23 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 16 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 29 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 19 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 17 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 22 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 21 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 15 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 24 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 28 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 26 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 20 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 18 repeal by EUR 2019/1020 Regulation
  • Ch. 3 Art. 25 repeal by EUR 2019/1020 Regulation
  • Art. 2(1) words substituted by S.I. 2019/696 Sch. 33 para. 3(c)(i) (This amendment not applied to legislation.gov.uk. Sch. 33 para. 3(c)(i) substituted immediately before IP completion day by virtue of S.I. 2020/1460, reg. 1(4), Sch. 3 para. 22(3)(a))
  • Art. 2(2) words substituted by S.I. 2019/696 Sch. 33 para. 3(d)(i) (This amendment not applied to legislation.gov.uk. Sch. 33 para. 3(d)(i) substituted immediately before IP completion day by virtue of S.I. 2020/1460, reg. 1(4), Sch. 3 para. 22(3)(b))
  • Art. 2(4) substituted by S.I. 2019/696 Sch. 33 para. 3(e) (This amendment not applied to legislation.gov.uk. Sch. 33 para. 3(e) omitted immediately before IP completion day by virtue of S.I. 2020/1460, reg. 1(4), Sch. 3 para. 3)
  • Art. 2(4) words substituted in earlier amending provision S.I. 2019/696, Sch. 33 para. 3(e) by S.I. 2020/852 reg. 4(2) Sch. 1 para. 1(s)(i) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 1(s)(i) omitted immediately before it comes into force by virtue of S.I. 2020/1460, regs. 1(3), Sch. 4 para. 1(3))

SECTION 2U.K. [F1Market] surveillance framework

Article 17U.K.Information obligations

F21.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.[F3The Secretary of State must take appropriate measures to] ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted.

Textual Amendments

Article 18U.K.Obligations F4... as regards organisation

F51.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.[F6The Secretary of State must] establish adequate procedures in order to:

(a)follow up complaints or reports on issues relating to risks arising in connection with products subject to [F7any relevant enactment];

(b)monitor accidents and harm to health which are suspected to have been caused by those products;

(c)verify that corrective action has been taken; and

(d)follow up scientific and technical knowledge concerning safety issues.

[F83.The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate to ensure that market surveillance authorities have the powers necessary for the proper performance of their duties.

The Secretary of State must entrust market surveillance authorities with the resources and knowledge necessary for the proper performance of their duties.

Regulations made under this paragraph must be made by statutory instrument.

A statutory instrument containing regulations under this paragraph may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.]

[F94.Market surveillance authorities must exercise their powers proportionately.]

[F105.The Secretary of State must establish, implement and periodically update the United Kingdom's market surveillance programme setting out the principles as to how market surveillance is to be organised and covering the sectors in which market surveillance is conducted in the United Kingdom. The Secretary of State must make this programme available to the public by way of electronic communication and, where appropriate, by other means.]

6.[F11The Secretary of State] [F12must] periodically review and assess the functioning of F13... surveillance activities [F14by market surveillance authorities]. Such reviews and assessments [F12must] be carried out at least every fourth year and the results thereof [F12must] F15... be made available to the public, by way of electronic communication and, where appropriate, by other means.

Textual Amendments

Article 19U.K.Market surveillance measures

1.Market surveillance authorities [F16must] perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they [F16must] take account of established principles of risk assessment, complaints and other information.

Market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary.

Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities [F16must] take due account of such reports or certificates.

2.Market surveillance authorities [F17must] take appropriate measures to alert users F18... within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage.

They [F17must] cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators.

[F193.Where a market surveillance authority decides to withdraw a product manufactured in the United Kingdom, it must inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying the product.]

4.Market surveillance authorities [F20must] carry out their duties independently, impartially and without bias.

[F215.Market surveillance authorities must observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirements that:

(a)information be made public under this Regulation to the fullest extent necessary in order to protect the users in the United Kingdom;

(b)the protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities.]

Textual Amendments

Article 20U.K.Products presenting a serious risk

1.[F22Market surveillance authorities must] ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on [F23the] market is prohibited, and that the [F24Secretary of State] is informed without delay thereof, in accordance with Article 22.

2.The decision whether or not a product represents a serious risk [F25must] be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk [F26does] not constitute grounds for considering that a product presents a serious risk.

Textual Amendments

Article 21U.K.Restrictive measures

1.[F27Market surveillance authorities must] ensure that any measure taken, pursuant to [F28any relevant enactment], to prohibit or restrict the product's being made available on the market, to withdraw it from the market or to recall it, is proportionate and states the exact grounds on which it is based.

2.Such measures [F29must] be communicated without delay to the relevant economic operator, which [F29must] at the same time be informed of the [F30legal] remedies available F31... and of the time limits to which such remedies are subject.

3.Prior to the adoption of a measure referred to in paragraph 1, the economic operator concerned [F32must] be given the opportunity to be heard within an appropriate period of not less than 10 days, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by health or safety requirements or other grounds relating to the public interests covered by [F33any of the relevant enactments]. If action has been taken without the operator's being heard, the operator [F32must] be given the opportunity to be heard as soon as possible and the action taken [F32must] be reviewed promptly thereafter.

4.Any measure referred to in paragraph 1 [F34must] be promptly withdrawn or amended upon the economic operator's demonstrating that he has taken effective action.

Textual Amendments

Article 22U.K.[F35Notification of serious risk]

[F361.Where a market surveillance authority takes or intends to take a measure in accordance with Article 20 it must immediately notify the Secretary of State of that measure.]

2.If a product presenting a serious risk has been made available on the market, [F37the market surveillance authority] [F38must] notify the [F39the Secretary of State] of any voluntary measures taken and communicated by an economic operator.

3.The information provided in accordance with paragraphs 1 and 2 [F40must] include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the related risk, the nature and the duration of the F41... measure taken and any voluntary measures taken by economic operators.

4.For the purposes of paragraphs 1, 2 and 3, the market surveillance [F42authority must notify the Secretary of State through the database containing information relating to market surveillance and product safety established by regulation 33(A1) of the General Product Safety Regulations 2005].

Textual Amendments

F43Article 23U.K.General information support system

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Textual Amendments

F43Article 24U.K.Principles of cooperation between the Member States and the Commission

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Textual Amendments

F43Article 25U.K.Sharing of resources

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Textual Amendments

Article 26U.K.Cooperation with the competent authorities of third countries

1.Market surveillance authorities may cooperate with the competent authorities of third countries with a view to exchanging information and technical support F44... and promoting activities relating to conformity assessment, market surveillance and accreditation.

F45...

F462.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Textual Amendments

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