Two More Notified Bodies About To Be Designated And Surge In Publications Of New Documents
The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.
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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.