The Virtual 5th EAAR Annual Conference on

New Medical Device Regulations

Erik will provide an update on the preparations for the application of the new regulations from a Commission perspective also touching upon the priority that is being given to Covid-19 related issues.

National Competent Authorities have several tasks under MDR and IVDR.
Main task for most of them is to conduct effective market surveillance. Helena will
give some examples illustrating challenges the authorities may face when we are
reaching the date of application for MDR and IVDR.

Notified Bodies play a key role in the implementation of the MDR and are the “final step” of
the very long and extremely important “preparation and certification process” of a
manufacturer of medical devices. It is well understood that challenges of the Notified Body
have an impact also on the manufacturer and challenges of the manufacturer have also an
impact on the Notified Body.

Taking this into account, Mr. Klaus-Dieter Ziel, Managing Director of the Notified Body
MEDCERT GmbH gives a presentation on his 4 main challenges, which are 1) initial MDR
audits under COVID-19, 2) the huge number of additional guidance documents which must
be taken into account, 3) the important differences of an MDD compared to an MDR
conformity assessment process and 4) the extremely high number of MDD certificates
expiring in 2023/2024.

The new European regulations have presented the medical device industry with new challenges in order to ensure compliance to the MDR and continue placing medical devices on the EU market.  This session will identify the key challenges experienced by non-European medical device manufacturers in preparing for compliance to the MDR, 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 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. Some of this is already published and more is on its way.

Most Medical Device Manufacturers knows how to structure and analyse related risks, but not many knows how to structure the benefit analysis to be able to complete the Benefit – Risk Assessment. Helene will provide you with a method to structure and analyse this process according to the new medical device regulations.

The Essential Requirements of the Directives have become the General Safety and Performance Requirements in the regulations. The original requirements have been mostly retained, but much detail has been added. New areas have been introduced such as cybersecurity, apps, CMR substances and nanomaterials.

Helene will teach you the overall processes in conducting a clinical evaluation; understand the requirement, the different stages and what other processes are connected to the clinical evaluation process.

This session explains the goals and objectives of the non-profit organisation, Team_PRRC set up last year to support individuals in the role of PRRC under the EU medical device regulations. It covers the basics of the qualifications and role of a PRRC along with the ways in which Team-PRRC aims to help those undertaking this new responsibility.