Europe - May 2021

EU: Commission issues proposal for a regulation on a European approach for artificial intelligence
EU: New and revised harmonised standards to support the medical device Directives
EU: Proposals for two Implementing Regulations announced by Commission
EU: Proposal on a Directive to adapt liability rules to take account of the digital age and artificial intelligence
EU: MDCG issues question-and-answer style guidance on clinical investigations
EU: MDCG provides answers to frequently asked questions on custom-made devices
EU: MDCG guidance on the application of transitional provisions for certification of Class D IVDs according to the IVDR
EU: MDCG publishes guidance on standardisation for medical devices
EU: Release of next two EUDAMED modules delayed
EU: Commission issues information on management of legacy devices in EUDAMED
EU: Proposed administrative practices and alternative technical solutions until EUDAMED is fully functional
EU: Commission’s second standardisation request sent to CEN and CENELEC
France: Functioning of CPPs has been simplified by new Decree
Norway: Legislative changes proposed to implement European MDR
Switzerland: Expected changes to the requirements for clinical trials involving medical devices
UK: ‘Medicines and Medical Devices Act 2021’
UK: Revised guidance on the application of the EU Regulations in Northern Ireland
UK: Pilot programme to streamline reviews of clinical investigations of medical devices

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