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The New EU Medical Device Regulations

The New EU Medical Device Regulations
Prepare for and explore the strategic implications of the new medical device and IVD regulations and discuss potential solutions with policy makers and key opinion leaders.


This conference will hear from the European Commission, who will provide an introduction on the new legislation including background reasons for it, timelines for implementation, transition periods etc. Following this we will hear from various competent authorities, notified bodies, industry and lawyers about the impact upon them and how they intend to plan for the changes.

The programme of 11 speakers is now confirmed with Erik Hansson of the EU Commission, Ricco Buitink of Ministry of Health, The Netherlands, Matthias Neumann of Federal Ministry of Health, Germany, Bassil Akra of TUV SUD, Germany, Petra Zoellner and Thecla Sterk of MedTech Europe, Peter Bogaert of Covington and Burling LLP, Belgium, Margareth Jorvid of LSM, Sweden, Janine Jamieson of JCombinations, Sweden, Dirk Stynen of Qarad, Belgium and chaired by Neil Adams of Ilumina, UK.

In the afternoon we will break into four workshops to discuss the concerns raised throughout the morning and to think strategically about how these concerns might be addressed. The four workshops are:
General Medical Devices concerns
General IVD concerns
Increasing convergence of medical devices and IVD’s with medicines
Economic Operators 

This is a Horizons conference to introduce the regulatory community to the new EU regulations. These regulations were adopted on 5 April 2017 with implementation 3 years after publication for medical devices and 5 years for IVD, see   http://europa.eu/rapid/press-release_IP-17-847_en.htm

Further TOPRA courses will follow on more detailed industry specific training, especially for IVD industry.

Download the programme

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Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.

Course Price (£):
Member: £550 + VAT
Non-member: £675 + VAT

Those working for regulatory agencies or government agencies or academic institutions: 
Member: £412.50 + VAT
Non Member: £506.25 + VAT
Those working for charities or patient groups:
Member: £275 +VAT
Non Member: £337.50 + VAT

For the discount code please contact meetings@topra.org

- Please note the number of discounted places may be limited.
- All fees are shown in Pounds Sterling and do not include VAT 
- Fee excludes accommodation and travel. The delegate ticket includes refreshments at coffee breaks and buffet lunches (if applicable).
Radisson Blu Royal Hotel Brussels Rue du Fosse-aux-Loups 47 B-1000 BRUSSELS BELGIUM
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