Past seminar

MDR & IVDR implementation – 7 MONTHS TO DATE OF APPLICATION

When

Wednesday 2 October 2019

Where

Pakhuis de Zwijger
Piet Heinkade 179
Amsterdam

What time

Registration and coffee

15:30

Start seminar:

16:00

Drinks and snacks:

18:30

26 May 2020, the date of application of the  Medical Devices Regulation (MDR) is seven months away at the date of this seminar. Yet, the MDR regulatory system is still not finished (implementing acts and guidance), essential infrastructure is still not on line (Eudamed) and conformity assessment capacity (notified bodies) is lacking. Industry and even several non-EU countries are more and more concerned about what the effect will be on the EU medical devices market. And then there is Brexit, to complicate matters even more.

Topics

This seminar will take stock of where we are with the roll-out of the MDR, what we know and what we do not know yet, what to expect and how to develop scenarios for the coming months that may make the difference between staying on the market or seeing cash flow collapse. Topics include the state of play of EU level implementation, what companies still can do and should be doing in light of the 26 May 2020 date of application as well as what the Eudamed database will look like, how to work with it and how to implement it in your organisation.


Speakers

Erik Vollebregt

Partner at Axon Lawyers

The knowns and the unknowns until May 2020 - what to expect and what not to expect, and how to plan for it

Paul van Geffen and Sue Spencer

QA / RA expert Senior Consultant resp. Head of IVD at QServe

The last elements of implementation before 26 May 2020

Ronald Boumans

Senior Consultant Regulatory Affairs and Person Responsible for Regulatory Compliance at Emergo

Latest developments regarding Eudamed: what will it look like and how to implement it?



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