The medical device industry faces growing pressure to align U.S. and EU regulations, with the EU’s Medical Device Regulation ...

The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes ...

A European Union regulation for medical devices produced and sold in the bloc has boosted cross-border expansion opportunities for firms that have adapted to the new rules, according to Mark Braganza, ...

The European Union's Medical Device Regulation (EU MDR) has become much more sophisticated and specific. Since taking effect in May 2017 the EU MDR includes more challenging protocols, including new ...

The evolving EU MDR and IVDR present key opportunities for companies to enhance compliance strategies, engage with notified bodies, and optimize market access. Staying informed and proactively ...

Good morning Eurohubsters, it’s Craig McGlashan here with the Dealflow. We’re always keen to look into ways that the European private equity market differs from the US and one of the biggest sectors ...

The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic. According to the European Commission, the Medical Devices ...

At the end of each year, we have a habit of looking back at lessons learned, the ups, the downs, the works. And like in 2020 and 2021, the COVID-19 pandemic and related shortage of medical devices ...

In May 2021, Europe’s medical device regulation (EU MDR) will go into effect, replacing the existing medical device directive (MDD) that is currently in place. The impact of this regulatory change in ...

LONDON (Reuters) - One year on from a breast implant scandal that shook confidence in Europe's light-touch system for regulating medical devices, lawmakers and manufacturers are at loggerheads on ways ...

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