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Regulation (EU) 2017/746 Article 53

Regulation (EU) 2017/746 Article 53

Voluntary change of notified body

Article 53

1.   In cases where a manufacturer terminates its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device, the detailed arrangements for the change of notified body shall be clearly defined in an agreement between the manufacturer, the incoming notified body and, where practicable the outgoing notified body. That agreement shall cover at least the following aspects: (a) the date on which the certificates issued by the outgoing notified body become invalid; (b) the date until which the identification number of the outgoing notified body may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the date after which the conformity assessment tasks of the outgoing notified body is assigned to the incoming notified body; (e) the last serial number or lot number for which the outgoing notified body is responsible. 2.   The outgoing notified body shall withdraw the certificates it has issued for the device concerned on the date on which they become invalid.

Read the full instrument → · Read this in context: Section 2 — Conformity assessment →

Other provisions in Section 2 — Conformity assessment

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 53 of Regulation (EU) 2017/746 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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