EU Regulatory Roundup, 2018: Year Of Dithering And Distractions Likely To Be Topped By Upcoming Year Of Turbulence And Stress
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.
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With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.
The EU Medical Device Regulation threatens the viability of many premarket innovators and SMEs in the UK, and across Europe. Eithne Lee, of ISO Life Sciences global consultancy, explains how the new requirements come as a shock for many small companies, how many are ill-prepared and how the cost of compliance relative to turnover may be too high. This is part one of a two-part article.