March 27, 2020

[FEATURED] Commission Firm on MDR Deadline But Could COVID-19 Emergency Measures Alter Date?

As COVID-19 begins to hamper EU Medical Device Regulation preparations, questions are being asked about whether the regulation might now be delayed. Medtech Insight spoke to top experts to find out more.

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December 18, 2019

[FEATURED] CE Featured Article BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow

There is not much demand currently for testing against the EU’s Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?

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August 29, 2019

[FEATURED] EU MDR: Handful Of Additional Notified Body Designations Await Go-Ahead

Recent indications from the European Commission led EU medtech stakeholders to believe that more notified bodies would have been designated by now. Not so, and the lack of any visible progress means that, for manufacturers, nerves will start to jangle again before long.

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July 25, 2019

[FEATURED] Brexit Delay Gives EU27 Yet More Time To Grow Number Of EU-Compliant Devices

Has the European Commission done enough to allow UK-certified medical devices to continue on the EU27 market in the event of the UK dropping out of the EU without a deal – a possibility that remains very real?

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July 2, 2019

[FEATURED] Notified Body Q&A: 3 NBs Talk EU MDR Enforcement, The IVDR ‘Big Bomb,’ ‘Tough’ Regulators – And More Insights

MEDCERT’s Klaus-Dieter Ziel, TÜV SÜD Product Service’s Bassil Akra and Qserve Group’s Gert Bos answered questions about the EU’s new Medical Device and In Vitro Diagnostic Regulations at MedCon 2019.

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[WEBINAR] How to Assess Your CER for MDR Readiness Part 1: State of the Art, Safety & Performance Criteria, Equivalence and Systematic Literature Review

Join our President, Laurie Mitchell, on April 29, 2020, at 11AM PST / 2PM EST to align your CER with some key MDR requirements. This live webinar will help you assess your CER and identify possible gaps for mitigation before submission.

Attendees are eligible for a free consultation and scan of their CER (or CER template). Spots are limited – click to register for this free webinar.