On 15 March 2023 (Regulation (EU) 2023/607), the EU extended both the transition period for the EU Medical Device Regulations (EU MDR) and the…
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In its white paper published last month, the UK Government set out its principles-based, adaptive approach to regulating AI. The UK approach stands in…
In brief Royal Decree 192/2023 on Medical Devices, which adapts Spanish national regulations to the provisions of Regulation (EU) 2017/745, was published on March…
In brief In a draft compromise text obtained by Politico, the European Council has dropped a key provision seeking…
In brief On 6 October 2022, Advocate General Medina issued an Opinion in three joined appeal cases brought by the…
Impact on medicines and medical devices In brief Medicines and medical devices are subject to the EU’s general…
In brief The UK government has recently published its roadmap for regulating AI as a medical device (AIaMD)…
In brief On 1 December 2022, Switzerland’s new Human Genetic Testing Act (HGTA) will enter into force. The…
Ukraine has adopted the new law on pharmaceuticals (“Law”) that fundamentally changes the regulatory framework for pharmaceuticals. The…