News & Analysis as of

Software Developers Manufacturers European Union

Fenwick & West LLP

The EU Updates its Products Liability Directive to Include AI

Fenwick & West LLP on

On Dec. 8, the European Union (EU) updated its Product Liability Directive (PLD) to, inter alia, specifically address AI software. This directive must next be “transposed,” or written into law by each of the 27 member states....more

Venable LLP

Preparing for the EU Cyber Resilience Act

Venable LLP on

The European Union (EU) is poised to enact the Cyber Resilience Act (CRA), a comprehensive cybersecurity regulation with major implications for software and connected device manufacturers in the United States and globally....more

Hogan Lovells

The EU Cyber Resilience Act: what to expect

Hogan Lovells on

The European Commission recently proposed the EU Cyber Resilience Act, a regulation on cybersecurity requirements for products with digital elements. The proposal introduces wide-ranging technical and governance measures that...more

MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

MoFo Life Sciences on

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more

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