Understanding the Intricacies of the Finalized EU IVD and Medical Device Regulation
1 Hour Video | Gert Bos, Qserve Group
After four years of debate and discussion, the EU announced that an agreement has been reached pertaining to the regulation of medical devices and in-vitro diagnostics, with a specific focus of prioritizing safety and efficacy. The legislation represents substantial changes to the European healthcare environment with increased stringency in areas such as clinical evaluation, transparency and stakeholder involvement, particularly that of notified bodies. The system is designed to allow regulators to make adjustments over time as necessary and will improve the availability of clinical to data to strengthen patient safety. Device and IVD manufacturers looking to market products in Europe need to fully understand these regulations and begin the implementation process as soon as possible to remain compliant.
- In-depth review of key provisions within the regulation
- New expectations and requirements for notified bodies
- Transition time frames, deadlines and re-certification processes
Participants that will find this webinar most beneficial will be those involved in medical device and diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Counsel
- Compliance Officers
Executive Director and Partner
Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level. From his PhD in Biomaterial Sciences, and PostDocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession over the last 15 years he has been awarded as Fellow of RAPS.
1 Hour Video | Anindita Saha and Martin Ho, Center for Devices and Radiological Health