Version in force , Modified +1,158 −58§
Amended by Regulation (EU) 2023/503 32023R0503 on EUR-Lex (external, EUR-Lex)
dates added to the text: 2023-03-11
Explanation, written by a model and checked against the cited text
The interval for the complete re-assessment of a notified body changed from three years after notification and every fourth year thereafter to five years after notification and every fifth year thereafter, and the reference to the joint assessment team procedure now cites Article 35 alone rather than Articles 34 and 35.
Two new subparagraphs were added allowing the authority responsible for notified bodies to conduct a complete re-assessment earlier than the scheduled dates upon the notified body's request or based on concerns from annual assessments, and addressing the continuation, suspension or termination of complete re-assessments already underway before 11 March 2023.
Cited: Art. 40, v1 (external, EUR-Lex) · Art. 40, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 28 January 2022 02017R0746-20220128 → this version, in force 11 March 2023 02017R0746-20230311
Article 40
Monitoring and re-assessment of notified bodies
1. Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in … 552 unchanged words … in Article 41.
9. The authority responsible for notified bodies shall document and record any findings regarding non-compliance of the notified body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective and preventive actions.
10. Three 5 years after notification of a notified body, and again every fourth year 5 years thereafter, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII shall be conducted by the authority responsible for notified bodies of the Member State in which the body is established and by a joint assessment team appointed for the purpose of in accordance with the procedure described in Articles 34 Article 35.
The authority responsible for notified bodies of the Member State in which the notified body is established may conduct a complete re-assessment prior to the dates referred to in the first subparagraph upon request by the notified body or where, based on the results of the annual assessments performed in accordance with paragraph 4 of this Article, it has concerns regarding the continued fulfilment by the notified body of the requirements set out in Annex VII.
Complete re-assessments that have already started prior to 11 March 2023 shall continue to be conducted, unless the authority responsible for notified bodies of the Member State in which the notified body is established decides to suspend or terminate the ongoing complete re-assessment taking into account its own resources and 35. the resources of the notified body already spent on the re-assessment, as well as the results of the annual assessments conducted in accordance with paragraph 4 of this Article. Before suspending or terminating an ongoing complete re-assessment, the authority responsible for notified bodies shall hear the notified body concerned.
11. The Commission is empowered to adopt delegated acts in accordance with Article 108 in order to amend paragraph 10 of this Article to modify the frequency at which the complete re-assessment referred to in that paragraph is to be carried out.
12. The Member States shall report to the Commission and to the MDCG, at least once a year, on their monitoring and on-site assessment activities regarding notified bodies and, where applicable, subsidiaries and subcontractors. The report shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be treated as confidential by the MDCG and the Commission; however, it shall contain a summary which shall be made publicly available.
The summary of the report shall be uploaded to the electronic system referred to in Article 52.