As of Dec. 1, 2022, the European Commission published the definitions of common specifications for the devices without a medical purpose listed in Annex XVI of the MDR (Regulation (EU) 2022/2346. The implementing regulation contains, in particular, specifications for the conformity assessment procedure and the requirements to be taken into account - so-called common specifications.

In particular, specific requirements and transition periods are defined for all those products that were previously not subject to medical device law but must meet the requirements of the MDR. The basic requirement is that the product has already been lawfully placed on the Union market before 22 June 2023 and continues to meet the legal requirements. Furthermore, the design and intended purpose of the product must not undergo any significant changes ( as defined in Art. 120 (3) MDR and MDCG 2020-3).According to Article 2 (2) of Regulation (EU) 2022/2346, these products may be placed on the market or put into service from September 22, 2023, until June 22, 2025, if a written agreement on the performance of the conformity assessment has been signed between the Notified Body and the manufacturer.

Special deadlines have also been set for devices for which a clinical investigation is carried out as part of the initial conformity assessment as a medical device.

Furthermore, we would like to refer to the current European discussion regarding the transition periods for already MDD-certified products, which may also affect products regulated under Annex XVI MDR.

We will inform our existing customers about the possibilities and procedures at mdc in time to meet these deadlines.