May 4, 2021

[FEATURED] TEAM-NB Highlights Survey Figures Suggesting Massive 2024 Bulge In MDR Applications

Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.

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April 27, 2021

[FEATURED] High-Risk Class D IVDs: Some Good News, Some Bad News About IVDR Implementation

The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.

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April 20, 2021

[FEATURED] Medtech Standards Request Advances – But Too Late For MDR/IVDR First Wave

The medtech sector may, at last, be one step closer to ensuring standards are drafted or revised under the EU’s MDR and IVDR. But delays have already meant industry has had to adopt “Plan B.”

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April 13, 2021

[FEATURED] EU Regulations At A Click: Top 10 Most Useful MDR/IVDR Webpages

The EU Medical Device Regulation will have impacts in countries beyond the EU27, a fact that is keeping MedTech Europe’s international team very busy.

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April 6, 2021

[FEATURED] Device Firms In Non-EU Markets Using The CE Mark Should Expect Some MDR Disruption After May

Health care is about to suffer a major setback and some devices and IVDs are going to have to be held back from the market if the regulatory status of the humble swab is not sufficiently recognized and urgently addressed.

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[WEBINAR] How to Assess Your CER for MDR Readiness: Part 2: Clinical Data Sources, Risk-Benefit Analysis and Overall Analyses and Conclusions

In this second installment of a 2-part webinar series on Wednesday May 12, 2021 at 11AM PST / 2PM EST, we will continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, and help you identify possible gaps for mitigation prior to submission to regulatory authorities.

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