Entry into force of the MD (MDR) and IVD (IVDR) Regulations: Publication of the Regulation and Q&A from the European Commission confirm the implementation modalities

Regulation (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards transitional arrangements for certain medical devices and certain in vitro diagnostic medical devices was published in the Official Journal of the European Union (OJEU) of 20 March 2023.

The entry into force of the MD and IVD regulations has therefore been officially postponed. This regulation extends the transition periods initially provided for by these regulations.

The practical details of these legislative changes were detailed in our previous article: " Postponement of the entry into force of the MDR and IVD Regulations ".

In order to go further, the European Commission has just published a question and answer on the practical aspects related to the implementation of this Regulation (EU) 2023/607. It sheds light on the scope, the evidence to be provided to demonstrate that legacy devices can continue to be placed on the market, the conditions for benefiting from the new transitional provisions and the monitoring of legacy devices by the notified bodies.

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