European Medical Device Conference 2021

Detailed programme Day 1: 9:00 am - 1:30 pm
Day 2: 9:00 am - 3:00 pm 09:00 Welcome and introduction (Chair: Dr Bassil Akra)
09:15 Erik Vollebregt Keynote: Where are we currently in the European medical device regulation?
10:00 Dr Caroline Dore Geraghty Notified Bodies at a glance

Overview about the current landscape of Notified Bodies

Which Notified Bodies are likely to experience bottlenecks?

What will happen with the Notified Bodies after 25 May 2021?

10:45 Coffee break
11:00 Dr Bassil Akra Clinical evaluation of medical devices - Current aspects of practical implementation

The changes to clinical evaluations by EU Regulation 2017/745

Annex XIV Part B

Fourth Revision of MEDDEV 2.7/1: Followed by a next update?

12:00 MinR Dr Martin Renhardt How national authorities deal with implementation

What's been done by the authorities so far: National and international

What is the implementation status?

Which points are still open (e.g. Germany/Austria)?

13:00 All speakers Panel discussion/Q&A
13:30 End of the first conference day
09:00 Welcome (Chair: Jan-Bart Hak)
09:15 Dr Arkan Zwick MDR readiness: Industry perspective

Insight on possible gaps from high-risk and combination products perspective

MDR implementation strategies

How to handle open regulatory "???"

10:00 Bastiaan Vliegenthart PMS/PMCF

What is to be observed from a regulatory point of view

Data gaps: Instructions for practice

Optimal PMS processes and integration with other iteractive processes

11:00 Coffee break
11:15 Jan-Bart Hak How's your vigilance going?

EU vigilance, regulatory innovations: How to meet reporting obligations?

Vigilance in clinical trials and the role of the state authorities

Notifications of market goods/recalls

Risk assessment by national authority

12:15 Lunch break
13:00 Dr Frank Stein How MDSAP could help you in difficult times?

Status of participating nations/NB

Procedure of MDSAP Audits

Synergies in int. audits in times of MDR

13:45 Boris Barth Product failure, recalls and patient safety: How to stay confident in critical situations

Professional risk communication in the MedTech industry

Crisis prevention: What is important and can be prepared in advance?

Question techniques of journalists and how to counter investigative questions

14:45 Concluding discussion
15:00 End of the conference

Detailed programme Day 1: 9:00 am - 1:30 pm
Day 2: 9:00 am - 3:00 pm 09:00 Welcome and introduction (Chair: Dr Bassil Akra)
09:15 Erik Vollebregt Keynote: Where are we currently in the European medical device regulation?
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