Language requirements & sanctions under the MDR: Belgium

The text of the Medical Device Regulation (MDR) will become directly applicable on the Union market on May 26, 2021. Nevertheless, the EU Member States have certain marge de manoeuvre when implementing the MDR into their national laws, especially related to the language requirements, clinical investigations, notified bodies and penalties. Today, we look at the case of Belgium.

The Wet van 22 december 2020 betreffende medische hulpmiddelen / Loi du 22 décembre 2020 relative aux . . .

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