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Regulatory Requirements European Union Medical Device Reports (MDRs)

Gardner Law

The EU Data Act Has Arrived

Gardner Law on

The EU AI Act has arrived, and the countdown to compliance is on. As of August 2, 2025, penalties, including administrative fines, are in force. ...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 6 Of 6)

MoFo Life Sciences on

In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the...more

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