The common specifications for non-therapeutic use devices under Annex XVI of the MDR have been published in the Official Journal of the European Union.
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Two Commission Implementing Regulations (EU) were published on 2 December 2022
- 2022/2346 laying down common specifications for the product groups without an identified medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
- 2022/2347 laying down detailed rules for the implementation of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the reclassification of groups of certain active products without an intended medical purpose
Both Regulations enter into force on the twentieth day after their promulgation (22 December 2022). However, Regulation No 2022/2346 shall apply from 22 June 2023, except for the provisions of Article 2(3), which shall apply from 22 December 2022. This is a transitional provision for products with a valid certificate under Directive 93/42/EEC covered by this Regulation.