The Virtual 6th EAAR Annual Conference on

New Medical Device Regulations

Anna-Eva Ampelas will present the new EU legislative framework for medical devices (MDR) & in-vitro diagnostic medical devices (IVDR). A state of play on the implementation of the New Regulations will be provided, including an overview of the main deliverables so far, challenges identified and next steps to achieve implementation priorities.

Amanda Maxwell will consider: the impact on the sector of the altered timelines for the implementation of the Medical Device and IVD Regulations; the challenges at notified body level; and other critical MDR implementation issues. Specific topics covered will include progress and shortfalls related to the Eudamed medical device database, expert panels and standards, amongst others. Mention will also be given to political changes in the EU.

The new European regulations have presented the medical device industry with new challenges in order to ensure compliance to the MDR/IVDR and continue placing medical devices on the EU market.  This session will identify some unique key challenges experienced by non-European medical device manufacturers in preparing for compliance to the MDR/IVDR, and the lessons learned and/or strategies being used by medical device manufacturers to address these challenges.

The changes in the scope and classification brought about by the new medical device regulation are evolutionary rather than revolutionary. They mainly reflect lessons learned and technological changes. A significant change is the addition of devices without a medical purpose within the scope of the regulation.

The borderline between medical devices and medicinal products is becoming sharper with new, more detailed definitions for pharmacological, immunological and metabolic means. 

The impact of technological change can be seen in the new rules on software, nanotechnology and closed loop systems.

The new requirements add to the complexity of compliance and imply the need of guidance. Although much relevant guidance is published, some of it is still in preparation, but likely to be issued soon.

Medical device manufacturers are obliged to demonstrate that their devices meet the General Safety and Performance Requirements (GSPRs) established in Annex I of the  MDR. In the past, under the MDD, an Essential Requirements “checklist” was frequently used to show conformity. However, the MDR now requires specific information to be  included to verify, validate and justify that GSPRs are met and a similar checklist  document may no longer be adequate. In this presentation, we will explore these new  requirements and provide insights into how to provide more robust justifications, with  and without the benefit of presumption of conformity conferred by common  specifications and/or technical standards harmonised with the MDR. In addition, we will  look at some common issues related to GSPRs and lessons learned when submitting  technical documentation for review. Early engagement with GSPRs to integrate them  into design requirements and device specifications is key to ensure that adequate  evidence is generated throughout the device development life-cycle to provide the basis for justification. Finally, meeting the GSPRs is an ongoing exercise to be ensured each time that devices are placed on the market. The Regulatory Compliance Strategy applied by the manufacturer therefore needs to include how applicable GSPRs are identified and met on an ongoing basis, in particular in the event of design changes, emerging risks or changes to the related standards.