The text of the Medical Device Regulation (MDR) became directly applicable on the European Union market as of May 26, 2021. Nevertheless, the EU Member States have certain marge de manoeuvre when implementing the MDR into their national laws, especially related to language requirements, clinical investigations, notified bodies and penalties. Today, we look at the case of Ireland.
The Statutory Instrument S.I. No. 261 of 2021 Medical Devices Regulations 2021 (SI) published in the Official Journal on 28 May 2021 regulates . . .
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