Status Update- MDR Surprises and Key Regulatory Developments
1 Hour and 30 Minute Video | Erik Vollebregt, Axon Lawyers
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
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Counsel
- Compliance Officers
Erik has 16 years experience as IP and regulatory lawyer. After his traineeship in the antitrust department of the European Commission he spent several years at international law firms. He is one of the founding partners of EU life sciences niche firm Axon and of the Alliance of European Life Sciences Law Firms. His practice comprises advice to and litigation for clients from the pharmaceutical, medical device and biotechnology industry in legal, regulatory, intellectual property and anti-trust matters. Erik is author of a numerous of publications on legal and regulatory subjects relating to pharmaceuticals and medical devices as well as editor of two Dutch (JGR and JGRPlus) and one international legal journal (eHealth Law & Policy) in the field of pharmaceutical law and medical technology law. He frequently speaks at national and international conferences of among others Advamed, DIA and RAPS and author of the acclaimed medical devices lblog Medicaldeviceslegal.com. Erik is member of Eucomed’s Data Protection Task Force and COCIR’s eHealth committee. He sits on European Commission’s Medical Devices Expert Group on New and Emerging Technology’s Special Interest Groups on mHealth, 3D printing and Horizon Technologies. Erik is member of the mHealth Stakeholder Group chaired by DG Connect of the European Commission.
1 Hour Video | Anindita Saha and Martin Ho, Center for Devices and Radiological Health