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Manufacturers New Guidance European Union

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

Hogan Lovells on

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

McDermott Will & Schulte

‘Pay-for-Delay’ Agreements can be Restrictions of Competition by their very Nature

On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...more

Latham & Watkins LLP

European Commission Publishes Chemicals Legislation Roadmaps

Latham & Watkins LLP on

The European Commission published two evaluation and fitness check roadmaps in May this year. These roadmaps will assist the Commission in assessing whether the current legislative framework for chemicals, including REACH, is...more

Latham & Watkins LLP

China Revises Hazardous Substances Restriction Laws

Latham & Watkins LLP on

China’s Ministry of Industry and Information Technology (MIIT) has recently announced a revised version of the Restriction of Hazardous Substances (RoHS 1), which will come into effect on July 1, 2016. The revised...more

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