European Regulations for medical devices and IVDs to enter in force in May 2017

This week the European Commission presented the current status of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR). The complexities of the new Regulations have become apparent during the English translation process. The Commission has now proposed the following timeframe for 2017:

  • End of Jan: final version of the English MDR due;
  • Mid-Feb: distribution of the English-translated MDR and all other EU languages to stakeholders;
  • Early March: Council to accept this version;
  • Early April: European Parliament to adopt the Regulations;
  • End of April: Formal publication expected;

With these proposed timelines, officially entry into power is scheduled for May 2017.

Full implementation deadlines for the MDR and IVDR would then be effective from May 2020 and May 2022, respectively.

Further news items will be posted when further publications become available.

Click here to contact us and discuss your implementation strategy.