The MDR and IVDR Transitional Provision Extension: What EU Sponsors Must Understand for Compliance

NAMSA sits down with Adrian Keene, Vice President of Global Biological Safety/Validation and EMEA Consulting Services, to discuss the EU Parliament’s approval of the transitional provision extension of the EU MDR and IVDR. Provided is information on how the amendment, passed on 16 February 2023, outlines new compliance dates for legacy device and removes the sell-off period for both medical and IVD products.

Meet the Expert

Adrian Keene, BSc (HONS); Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services, NAMSA

With 26 years of experience in the medical device industry, Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products.

Prior to working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS. Before working with the notified body, he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Device Directive (MDD).

He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.