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.

Swissmedic has updated its checklist for materiovigilance inspections in hospitals, covering medical devices and IVDs, quality management, reporting, traceability, FSN/FSCA processes and staff training.

The European Commission expert panel has issued a CECP scientific opinion on a Class III implantable dual-chamber leadless pacemaker, highlighting clinical evidence, benefit-risk assessment and PMS considerations.

The MHRA has updated its guidance on the management and use of in vitro diagnostic point-of-care test devices, including POCT services in primary and secondary care settings.

MedTech Europe has responded to the European Commission’s Call for Evidence on future European Partnerships implemented as Joint Undertakings under the next Multiannual Financial Framework.

The MHRA has updated its list of UK approved bodies authorised to undertake conformity assessments for medical devices under the UK MDR 2002.

Swissmedic has updated its information sheet on clinical investigations of medical devices, including approval procedures, ISO 14155, category C investigations, reporting duties and IMDRF adverse event terminology.

From 1 July 2026, certain medical devices supplied in Australia must meet TGA Unique Device Identification requirements, starting with Class IIb and Class III devices.

FDA CBER has updated SOPP 8704 on MDUFA user fee payments and billing activities, including electronic payments, payment verification, user fee holds, refunds and establishment registration fees.

NBCG-MED has published operational elements for the application of hybrid audits to QMS assessments under the MDR and IVDR, including on-site requirements, ICT use and audit planning.

The European Commission has published a draft implementing regulation amending common specifications for certain Class D IVDs under the IVDR, including HEV, Toxoplasma gondii, Plasmodium and arboviruses.

Swissmedic has updated its information sheet on IVD performance studies, covering approval procedures, reporting duties, ISO 20916, category C studies and Swissmedic surveillance.

The MDCG has updated its guidance on standardisation for medical devices, covering harmonised standards, presumption of conformity, state of the art, common specifications and EU case law.

The MHRA has updated its guidance on clinical investigations for medical devices, including applications, assessment timelines, amendments, reporting requirements and fee waiver information.