STATUS UPDATE- MDR SURPRISES AND KEY REGULATORY DEVELOPMENTS

The MDR is currently being translated into each of the official EU languages and is expected to enter into force in Q1 of 2017. Last minute political negotiations have resulted in a variety changes and interpretations that will have a significant impact on device manufacturers. These changes include the revision of the mandatory clinical evaluation consultation procedure, reclassification of clinical decision support software and amendments to the transition regime. In order to fully prepare for successful implementation and management of the regulation, manufacturers must have a better understanding of the most recent changes and how they apply to their organization.

• Next steps in regulation approval- “Date of entry into force”
• Real world timelines and application of transitional regime

Speaker:
Erik Vollebregt
Partner
Axon Lawyers