April 11, 2019

[FEATURED] IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU’s IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

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March 18, 2019

[FEATURED] Notified Bodies And EU Industry Voice Separate, But Aligned Frustrations Over Slow Progress In NB Designations

Notified body and medtech industry trade associations both issued formal statements pointing out that delays in designating notified bodies are the biggest barrier to products being able to comply with the new EU Medical Device Regulation before deadlines. Time is running out.

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March 1, 2019

[FEATURED] 33-Country Single Market For MDR And IVDR, And Bigger Reach Beyond

More often than not, the new EU Medical Device and IVD Regulations are talked about in the context of the 28 countries of the European Union (including the UK, for now). In reality, the regulations will have a much wider reach and influence, with Australia making particular efforts to align with the EU.

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February 16, 2019

[FEATURED] 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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February 4, 2019

[FEATURED] Complying On Time With MDR/IVDR: What Options Are Open To Those In Trouble?

Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.

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MedTech Summit 2019

June 17-21, 2019

Crowne Plaza Brussels – Le Palace, Brussels

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Already registered? We’ll see you there! Book a meeting with us at booth #9.