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EU Regulatory Roundup, 2018: Year Of Dithering And Distractions Likely To Be Topped By Upcoming Year Of Turbulence And Stress

 
• By Amanda Maxwell

2018 needed to be medtech's year to focus on the ongoing implementation of the EU MDR and the IVDR and the structures and documents to support them.  But lack of progress means a 2019 work bulge amid Brexit issues and recent journalistic investigations. Here's a look at the top EU regulation issues and articles of the past year.

Top Stories EU

November 2018 was the halfway point for the implementation for the Medical Devices Regulation (MDR), which fully applies on May 26, 2020. The IVD Regulation fully applies exactly two years later. As such, the sector had anticipated that 2018 would have seen a flurry of new structures and documents created to enable all players to prepare to comply in time with the new. Judging by Medtech Insight readers' high level of interest in articles related to how to implement the regulations, this is what was most needed.

But implementation progress has been slow. While the European Commission's Erik Hansson expressed confidence in October that the Commission...

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