11.05.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that on 10 May 2023, the European Commission posted the final draft of the Commission’s Implementing Regulation, amending the transitional provisions established in Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose, on the Commission’s website and is open for comments until 06.05.2023. Comments can be sent to the Commission.
This project is proposed for reasons of coherence and in order to provide legal certainty to economic operators by aligning the provisions relating to the transition periods in the Implementing Regulation R(EU) 2022/2346 for products covered by a certificate issued by a notified body according to Directive 93/42/EEC with those of Regulation R(EU) 2017/745, as amended by Regulation R(EU) 2023/607.
The notification of the European Commission is available online at: Amendment of common specifications for products without intended medical purpose listed in Ann. XVI – Reg. (EU) 2017/745 (europa.eu)
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