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 16, 2021

[FEATURED] Signs Of Hope But Obstacles Remain For Swiss Device MRA With EU

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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February 9, 2021

[FEATURED] Common Regulatory Starting Point Means EU-UK Are On Track For Medtech MRA, Say German Firms

With Brexit less than a month old, Germany’s medtech industry has renewed its push for an MRA between the EU and UK in medtech regulation.

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October 5, 2020

[FEATURED] Industry Awaits Commission Ruling On Virtual Audits Under MDR

Many medtech companies are ready to demonstrate compliance with the EU MDR, but COVID-19 notified body auditing restrictions have brought their plans to a halt. The EU is trying to break the impasse.

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August 25, 2020

[FEATURED] Unprecedented Number Of EU Medtech Guidance Documents Now Available On New Commission Website

The European Commission’s output of guidance documents over the last few months has been extraordinary, and unprecedented. A new website gives users access to all these documents and shows what has changed.

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