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Set Alert for Policy and Regulation - Europe

Critical EU Authorities Meeting Next Week Could Be Make-Or-Break For Many Medtech Companies

The EU medtech industry is trying to put the brakes on the full application of the new Medical Devices and IVD Regulation as a logjam looms. What is it doing to succeed? And why is time running out?

Europe Policy & Regulation Policy

Latest From Europe, Policy & Regulation

IVDR Notified Body Pulls Applications As The EU System Struggles To Cope

European Commission figures have already suggested IVD testing capacity could be woefully short of demand. Now one notified body applicant is dropping out. What are the implications?

Europe Regulation

Can EU Regulations Be Changed To Allow For More Time? MedTech Europe Says 'Yes'

Huge numbers of products risk failing to comply the new EU regulations in time. Are efforts to extend deadlines legally and practically possible and will they be supported? MedTech Europe's Oliver Bisazza talks with Medtech Insight.

Europe Regulation

French Supreme Court Finalizes PIP Fraud Rulings And Executive Sentencings

Medtech notified body TÜV Rheinland has been recognized as a victim of large-scale fraud in a final-instance ruling in the French criminal case that has led to the conviction and sentencing of the executives at the center of the EU PIP breast implant scandal.

Legal Issues Europe

Brexit: UK Promises Medtech Brexit 'No-Deal Consultation' As UK Teeters On Cliff Edge

The UK's MHRA is promising a consultation process to seek feedback on how medtech would be impacted by a no-deal Brexit; industry is currently left with many unanswered questions and a lack of informed, expert speculation.

Brexit Medical Device

Questions Abound: UK MHRA Brexit Proposal For Medtech Leaves Much Unsaid, Much To Fear

Questions outnumber answers for medtech following the UK's recently issued "technical notices" on the implications if the UK does not reach a Brexit agreement with the EU before March 2019. Below we list the critical outstanding questions based on a Medtech Insight analysis and discussion with several top experts in the field. These questions have also been put directly to the UK's MHRA and the European Commission.

Brexit Europe

EU Regulatory Roundup, August 2018: More Push For Reg Delays; Brexit Planning Raises Questions

Device companies, under increasing time pressures, gained the support of some EU member state ministers to lengthen transitions for the new regulations. Also, the UK disclosed more about what could happen in the event of a no-deal Brexit. That, and more, in Medtech Insight's August top 10 articles covering EU regulations.

Regulation Policy
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