Leveraging Post-Market Surveillance and Clinical Follow-Up Data to Support EU MDR Compliance

Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) have been an important part of conformity to the Medical Device Directive 93/42 EEC (MDD) and Active Implantable Device Directive 90/385/EEC (AIMD). However, there is an increased emphasis on PMS and PMCF compliance under the new EU Medical Device Regulation 2017/745 (MDR). 

The absence of any grandfathering of product conformity means that all existing products will need to demonstrate they fully comply with the increased expectations of the new EU regulation. Further, there is a significant risk of the removal of products from the EU market as a result of not meeting the new requirements for CE certification – even for manufacturers currently holding CE marks. As a result, there is an urgent need for manufacturers to:

• Ensure that existing PMS processes and outputs are robust
• Plan and implement PMCF activities to fill any gaps and support maintenance on the EU market
• Confirm the availability of clinical data to support ongoing CE certification upon MDR implementation
  

This NAMSA webinar will be offered in partnership with Xtalks, and will be presented by Adrian Keene, NAMSA’s Director of Product Development Strategy and former Head of Notified Body SGS in the UK.

Following this online event, attendees will:  

1.  Understand the impact of the MDR to devices that are currently CE-marked
2.  Evaluate weaknesses in existing PMS data
3.  Learn how to leverage PMS data to support compliance with the new regulation

Time will also be allotted for questions.

Speaker

Adrian Keene, Director of Product Development Strategy, NAMSA

Adrian is Director of Product Development Strategy at NAMSA, where he utilizes his broad experience in changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He has worked with a broad range of devices, including drug-device combination products.

Adrian was previously the Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In total, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London 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.

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