Team-NB updates its consensus position paper on the MDR certification process, standardizing pre-application, technical file review, and EUDAMED logging.

European Union publishes Regulation (EU) 2026/1744 (Digital Omnibus on AI), amending the EU AI Act to streamline compliance, adjust timelines, and relieve SMEs.

FDA issues new guidance on cancer clinical trial eligibility, recommending broader inclusion of patients with ECOG PS2 and KPS 60–70 performance status.

Discover the new FDA guidance on oncology trial eligibility criteria, risk-based washout periods, and concomitant medication management for clinical studies.

The MHRA has updated its guidance on clinical investigations for medical devices, covering notification requirements, fees, applications, assessment, amendments, reporting and Northern Ireland requirements.

The MHRA has updated its guidance on determining whether a clinical investigation is required for medical devices in Great Britain, covering pre-clinical testing, PMCF, medical purpose, research tools and notification requirements.

Commission Implementing Decision (EU) 2024/2120 renews the designation of UDI issuing entities for medical devices and IVDs for a further five-year period, until 27 June 2029.

FDA has issued draft guidance on biocompatibility testing of medical devices under the ASCA Program, covering recognized standards, laboratory accreditation, test methods and premarket submission content.

MDCG 2026-5 clarifies that only the manufacturer can assign UDIs to devices placed on the EU market, even where distributors market devices under their own brand.

The European Commission and EU Member States have launched the second phase of the COMBINE pilot programme, expanding coordinated assessment to additional types of combined clinical trials involving medicines and medical devices.

Regulation (EU) 2017/745 sets out the European regulatory framework for medical devices, covering market access, economic operators, clinical evaluation, vigilance, PMS, UDI and notified bodies.

The European Commission has published Member State summaries of the 2025 annual reports on monitoring and on-site activities regarding notified bodies under the MDR and IVDR.

Swissmedic has updated its information sheet on performance studies of IVDs, covering study categories, approval processes, ISO 20916, reporting duties, safety measures and sponsor obligations.

The MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices, including classification, custom-made devices and examples.

The MHRA has updated its guidance on custom-made medical devices in Great Britain, covering definitions, conformity assessment, UKCA marking, statements, PMS, vigilance and registration.

The MHRA has updated its guidance on registering medical devices, IVDs, custom-made devices, systems and procedure packs for the Great Britain and Northern Ireland markets.

MDSAP has extended its voluntary pilot program allowing eligible Medical Device Organizations to participate in and apply for MDSAP certification until April 2027.

The World Health Organization has published a transitional list of WHO Listed Authorities for medical devices, supporting regulatory reliance for medical devices and IVDs.

The European Commission has commissioned a study to monitor the availability of medical devices on the EU market, including dashboard data and surveys of notified bodies, economic operators and health service providers.

Health Canada has issued a notice to industry on Class III and IV medical device licence applications, advising applicants to submit only relevant information, clear summaries and accurate supporting evidence.