Introduction & Contents

Welcome...

Over the course of a week on 12 – 16 October 2020, MedTech Summit went virtual for the first time. Over 100 top medical device, diagnostic and combination product speakers, and 15+ Competent Authority and Notified Body representatives presented 50 hours of live and on-demand sessions across 9 tracks.

Attendees from 39 countries across Europe and the rest of the world discovered the latest guidance on the EU Medical Device Regulation, Post Market Surveillance and Vigilance, clinical evaluations and investigations, EU IVD Regulation and strategy, EU medical device law, software and AI, medical device regulatory affairs in global markets, drug device combination products and biocompatibility for medical devices.

Here we have gathered together the highlights of the week in this post-event report, featuring analysis from MedTech Insight of the key discussions and stories that came out of the event.

Jump to any article using the contents on the following page, or at any time using the Contents menu in the top left. There you can also download this report as a PDF.

Contents

1. Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid

Where are the biggest challenges for notified bodies and manufacturers now there is some experience with the MDR, and can the sector manage the new regulatory requirements successfully?

2. EU Faces MDR Failure Unless It Adjusts To COVID-19 Crisis And Grows Notified Bodies

Is the current pandemic too big a hurdle for the EU’s medtech regulators and industry alike? What else might hold EU medtech back from the successful implementation of the MDR?

3. Permitting Initial Virtual Audits under the MDR: Commission Decision Hangs in the Balance

The European Commission is wavering as pressure builds for it to allow initial audits to be performed virtually under the Medical Device Regulation.

4. The Politics and the Practice of UK Standalone Devices Regulation

Taylor Wessing partner Alison Dennis and MHRA devices regulatory policy manager Gavia Taan provide updates on the UK’s device regulatory plans after the Brexit transition period ends.

5. Experts Call For Unifying Measures For EU Political And Regulatory Oversight

Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient safety throughout the EU, not least through increasing costs and impacting device availability.

6. Making The Leap From EU MDD To MDR Clinical Evidence: Practical Advice

Following her session at Medtech Summit, Medtech Insight interview Maetrics’ Dr Amie Smirthwaite for a practical overview of how to meet the new clinical evidence requirements.