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Europe

Set Alert for Policy and Regulation - Europe

GDPR: The Multiple Ways In Which Medtech Is Impacted, And Needs To Comply

With just over one week to go until the General Data Protection Regulation (GDPR) fully applies, are you sure your company is fully compliant? Anything overlooked? Attorneys Renzo Marchini and Robert Fett answer Medtech Insight's questions.

Cybersecurity Europe Digital Health
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Latest From Europe, Policy & Regulation

Concerns Rise For Notified Bodies Over Potential Reopening Of PIP Case

Medtech notified bodies need to monitor PIP liability issues again as France's top court weighs in. Will it trigger a reopening of the TÜV Rheinland liability case? And what might it mean for notified bodies in general?

Europe Legal Issues

New Dutch Chair For Pivotal EU Medtech Authority Group

The new executive group chair of the Competent Authorities for Medical Devices will help steer EU medtech through one of the trickiest times in its regulatory history, as the key national authorities group loses its UK lead.

Medical Device Europe

QUOTED. May 17, 2018. Renzo Marchini & Robert Fett.

The May 25 deadline for the EU's General Data Protection Regulation is rapidly approaching. See what attorneys Renzo Marchini and Robert Fett have to say about some of the considerations for medtech companies.

Cybersecurity Digital Health

Medtech Reg Progress In Russia, CIS And Eurasian Union At Operational Level

Various economies of the Commonwealth of Independent States (CIS) and the Eurasian Economic Union (EAEU) are pressing ahead with medtech regulatory changes nationally and/or regionally, which can only be good for the delivery of quality care over the long term. But a question mark still hangs over the official start date of the EAEU medtech regulatory system; a formal postponement may be decided soon.

EAEU Belarus

Belgium Ushers In Complex New Country-Specific Registration Requirements Pending Eudamed

Belgium is introducing new registration requirements for medical device and IVD operators June 17, ahead of the full application of the EU's medtech regulations and new Eudamed medical device database.

Europe Belgium

Brexit Update: UK Medtech Industry Viewpoint, And One Notified Body's Strategy

The case for and against Brexit is only becoming more complex as the months advance toward Brexit Day (March 29, 2019) and the December 2020 end of the UK transition/implementation period. Offering what support it can, UK medical device industry association ABHI held a Brexit information seminar in April. At the gathering, UK notified body BSI revealed the thinking behind its current plans.

EU Brexit
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