Navigating the EU MDR's clinical evaluation and post market surveillance requirements can be daunting. Many manufacturers have difficulty understanding the MDR’s interpretation of the clinical evaluation and post market surveillance processes. Although these processes are already required by MDR Article 120, many are surprised by the depth of changes. The processes may seem deceivingly simple. For example, the MEDDEV 2.7/1 rev 4 is included, verbatim, in the MDR text. Nevertheless, many manufacturers are taken aback when facing their MDR notified body's questions the first time.

This webinar sheds light on these critical processes from the notified body perspective and is intended to raise awareness of all sources of information used to evaluate compliance. You will gain an understanding of key changes, concepts, and guidelines that impact your medical device certification.

Objective

To provide an overview of the clinical evaluation process and post market surveillance requirements for MDR certification.

Agenda

EU MDR manufacturers' clinical evaluation overview (focusing on differences from MDD).
Explanation of new or reinforced concepts.
Expectations where new clinical investigation is expected.
Changes in the clinical investigation plan, ethics committee, etc.
Applicable guidelines (MDCG2020-05, MDCG2020-06, MDCG2020-07, MDCG2020-08, MDCG2020-01, MDCG2021-06, MDCG2022-21, etc.).
Changed CEA workflow from the NB and CA perspective (including consultation process where applicable).

Target Audience

This webinar is aimed at regulatory professionals and legal manufacturers of medical devices intended to be sold in the EU under the MDR.

Language: English

Cost: No Charge

Can't make a live session? Register now and receive a complimentary recording after the live event.

Speakers

Balázs Bozsik
Technical Director – MDD/MDR, SGS

Mr. Balazs Bozsik, technical director of SGS North America’s medical audit team, has a passion for continuous improvement. Following his graduation as an integrated mechanical engineer from BUTE in Budapest, Hungary, he gained industrial experience in manufacturing technology and design engineering in the medical (X-ray diagnostic devices), automotive and consumer lighting industries. Prior to joining SGS, he worked for another TIC organization for over 14 years where his roles included global MDSAP program manager, certification officer, product specialist focusing on active medical devices and medical software and medical auditor for all major certification schemes.

Greg Jacobson
Sales Director – Medical Devices, SGS

Greg Jacobson is Director of Sales for SGS North America’s medical division As a senior sales and medical device professional, he contributes to strategy, recommends resourcing requirements and improves sales processes to drive client satisfaction. Greg has many years of experience in medical devices certification sales. Within the last 10 years, he has been responsible for managing high risk device accounts. He has also held other sales roles both inside and outside of the TIC Industry.

For further information, please contact:
Dominic James
Marketing Assistant
t: +1-201-508-3000