Key Postmarket Surveillance Considerations for Transitioning to the New EU Medical Device Regulation
In light of recent approval of the EU Medical Device Regulation (MDR), manufacturers already in the European market must begin transitioning to meet the new expectation for continuous evaluation. In particular, the MDR elevates the importance of postmarket surveillance through manufacturer-mandated procedures to collect and review feedback from healthcare professionals and patients. A seasoned expert in the MDR will address the postmarket surveillance component and key steps manufacturers conducting business in Europe should take to adhere to the new regulation.
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:
- Post Market Surveillance
- Post Market Quality
Laure Le Calvé
Founder and Partner
LCH (Le Calvé Héricotte – Law Compliance Health)
Laure Le Calvé is a founder and partner of LCH (Le Calvé Héricotte – Law Compliance Health), a French law firm dedicated to health businesses. She holds a French Master degree in International Business Law, a UK LLM in International Business Law and was admitted magna cum laude to the Paris Bar. She mainly advises medical devices manufacturers and pharmaceutical companies, on all operational aspects of their business: clinical trials, research and development, data protection, regulatory rules applying to health products, marketing authorizations, pricing and reimbursement, advertising, product liability, royalty agreements, distribution agreements, interactions with physicians, transparency and, bribery, e-health matters. Laure Le Calvé regularly gives lectures on health law aspects in congresses and seminars (notably at SNITEM and SIDIV – French trade associations of medical devices and IVD devices manufacturers and ADVAMED) and is the author of several publications. She is member of the legal committee of Eucomed.
1 Hour Video | Anindita Saha and Martin Ho, Center for Devices and Radiological Health