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Europe

Set Alert for Policy and Regulation - Europe

Making Sense Of The Muddle Of EU Device Registration Timelines

The recent document from the European Commission's Medical Devices Coordination Group concerning device registration timelines is difficult to follow, with its many unexplained references. This article aims to clarify how the MDCG's findings affect the way manufacturers should prepare for MDR compliance.

EU Regulation Medical Device
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Latest From Europe, Policy & Regulation

Sharp Rise In EU MDR Notified Body Applicants Is Pleasant Surprise

The number of EU notified bodies applying for designation against the EU MDR has risen by over a third in the past nine months, the European Commission reports. IVDR applicant numbers are up slightly too. But are the increases enough to ease the anticipated bottlenecks?

EU Regulation

Commission Told New EU Regulation ‘Clearly Untenable’ And ‘Not Ready To Function’

With just over 13 months until the EU Medical Devices Regulation is fully applicable, EU medtech manufacturers are imploring the European Commission to speed readiness of the new regulatory system or patients and industry will suffer.

EU Regulation

Legacy Devices In Eudamed Database: MDCG Proposes Regulatory Solution

The new EU medical device regulations  ̶  the MDR and IVDR – left a gap in how manufacturers of legacy products should comply with critical reporting requirements. A solution has been found.

EU Regulation

Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices

Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?

Brexit EU

German Industry Is Winning Medtech Aids Quality Battle, If Slowly

The price versus quality standoff surrounding the supply of medtech aids and assistive-care products prescribed in the German primary- and ambulatory-care settings goes on. A ban on tenders, which can imbalance the market with large supplies of lower-quality imports, has soothed industry’s frustrations, but the battle is not over yet. 

Germany Policy

The Legal Gap Allowing Competitors To Exploit Eudamed

Will Eudamed, the European Database for Medical Devices, offer a free source of information for competitors which disadvantages original companies? Vincenzo Salvatore of international law firm BonelliErede highlights how the legal gap around the further utilization of data may be detrimental to some and advantageous to others.

EU Regulation
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