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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March 30, 2021

[FEATURED] Why The Humble Swab Could Be A Seriously Disruptive Element In The MDR And IVDR

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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March 23, 2021

[FEATURED] EU MDR Notified Body Designations Could Soar By A Third By End Of 2021

Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having to find ways of limiting the damage that newly erected barriers will cause after the MDR comes into force.

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[WEBINAR]

State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness

Join us for our LIVE webinar on April 21, 2021, at 11AM PST / 2 Pm EST. In this engaging presentation, Dr. Sarah Chavez will provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.