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Software Surveillance European Union

Akin Gump Strauss Hauer & Feld LLP

Guidelines on the Export of Cyber-surveillance Items Under Article 5 of Regulation 2021-821

In 2021, the European Union (EU) updated the EU Dual-Use Regulation, setting unified standards for EU member states to control exports of dual-use items. A key addition in Regulation (EU) 2021/821 is Article 5’s “catch-all...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 4 Of 6)

MoFo Life Sciences on

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more

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