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Set Alert for Policy and Regulation - Europe

EU Industry Says Real Work Starts Now On Regulations

Industry recognizes considerable work has been done on cleaning up the texts of EU's future Medical Device and IVD Regulations. But it emphasized that further work is needed in the implementation phase to bring legal certainty and clarification.

Regulation Medical Device Europe
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Latest From Europe, Policy &Regulation

Brexit Podcast: Next Steps For The UK Medtech Industry

Ashley Yeo talks to Association of British Healthcare Industries' Nishan Sunthares and Richard Phillips about the subject that will dominate the thoughts, behavior and business of medical technology companies in the UK for many years to come.

Brexit United Kingdom

New EU Regulations: Guide To Latest – Likely Final – Texts

Why are there so many more pages and articles in the latest, likely final, versions of the Medical Devices Regulation and the IVD Regulation compared to the 2016 versions? What do these changes mean for the regulations, which are due to be adopted imminently?

Regulation Medical Device

Russian Medtech Industry Wants Quicker Progress On Eurasian Bloc Plans – 2017 Now Targeted

The much-anticipated Eurasian Economic Union (EAEU) was originally targeted to come into effect at the start of 2016, but more than year later, the five-member trading bloc has yet to be ratified by all nations. The Russian medtech industry is impatient for progress, but IMEDA's Sergey Kolosov sees some promising signs in recent developments.

Russian Federation Regulation

More Tweaking Of EU Regulations ‘Unlikely’ As Latest Texts Are Issued

The Council of the European Union published the latest versions of the Medical Device and IVD Regulations, and the timelines to full implementation are now clearer.

Europe Regulation

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

Unannounced Audits In EU Not Obligatory, Commission Confirms

Will notified bodies be let off the hook when it comes to unannounced audits now that it is official they are not mandatory? And what is the role of national courts in notified body liability?

Compliance Europe
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Latest From Europe &Quality Control

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

An Auditor's Take: Unrealistic EU Demands Are Causing Notified Body Exodus, Potential Company Collapses

Demands related to auditor education, experience and affiliation are making it difficult for notified bodies to retain and hire staff. This comes on top of much tougher regulatory requirements. One notified body auditor explains why the situation might be killing notified bodies when they are needed most.

Regulation Europe

Europe – Are You Ready For Unique Device Identification?

Europe-based device companies should look to the experience of the implementation of Unique Device Identification in the US to prepare for the upcoming UDI mandate in the EU, Steve Cottrell and Madris Tomes explain in this guest column.

Regulation Europe

Warning Letter Roundup & Recap – Aug. 16, 2016

FDA finds QS and marketing violations at a host of international device-makers. FDA released warning letters to 14 device companies this week.

Policy & Regulation Quality Control
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