06.12.2022
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
We hereby inform you that on 1 December 2022, Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices was published in the Official Journal.
Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. Regulation (EU) 2017/745 further requires the Commission to adopt for groups of products without an intended medical purpose listed in its Annex XVI, common specifications addressing, at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding safety.
Classification rules 9 and 10 on active devices in sections 6.1. and 6.2. of Annex VIII to Regulation (EU) 2017/745 refers to an intended medical purpose, namely for therapy and diagnosis, and therefore cannot be applied to active products without an intended medical purpose, referred to in Article 1 paragraph (2) of this Regulation. Therefore, such products must be classified in class I in accordance with rule 13 of section 6.5. of Annex VIII to Regulation (EU) 2017/745.
The announcement of the European Commission is available online at: EUR-Lex – 32022R2346 – EN – EUR-Lex (europa.eu) și EUR-Lex – 32022R2347 – EN – EUR-Lex (europa.eu).
download document …
download document …