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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December 30, 2018

[FEATURED] When Will EU Commission, Member States React To Calls For Extending Regulation Deadlines?

The EU medtech sector, seeing itself heading for a crisis, is hoping the authorities will imminently extend deadlines for the Medical Device and IVD Regulations. What more do we know after last week’s crucial Medical Device Coordination Group meeting?

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June 20, 2018

[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?

Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to notified bodies?

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October 4, 2017

What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices

Signing document

On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects of device regulation. (more…)

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MedTech Summit 2019

June 17-21, 2019

Crowne Plaza Brussels – Le Palace, Brussels

Don’t miss out on the early bird discount – register before March 29th to get £300 off.

Save an additional 25% off your registration fee by clicking this link.

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