MDCG Publishes Position Paper on UDI Assignment Between Manufacturers and Distributors
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.
COMBINE Programme Advances to Second Phase of Coordinated Assessment Pilot for Combined Clinical Trials
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.
EU MDR Establishes Comprehensive Framework for Medical Devices in the European Union
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.
European Commission Publishes 2025 Member State Summaries on Notified Body Monitoring
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 Updates Information Sheet on IVD Performance Studies
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.
MHRA Updates Guidance on Legal Requirements for Specific Medical Devices
The MHRA has updated its guidance on legal requirements for prosthetic, orthotic and ophthalmic devices, including classification, custom-made devices and examples.
MHRA Updates Guidance on Custom-Made Devices in Great Britain
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.
MHRA Updates Guidance on Registering Medical Devices for the UK Market
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 Extends Pilot Program Allowing Medical Device Organizations to Apply for Certification
MDSAP has extended its voluntary pilot program allowing eligible Medical Device Organizations to participate in and apply for MDSAP certification until April 2027.
WHO Publishes Transitional List of WHO Listed Authorities for Medical Devices
The World Health Organization has published a transitional list of WHO Listed Authorities for medical devices, supporting regulatory reliance for medical devices and IVDs.
European Commission Study Monitors Availability of Medical Devices on the EU Market
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 Clarifies Expectations for Class III and IV Medical Device Licence Applications
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 Updates Checklist for Materiovigilance Inspections in Hospitals
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.
European Commission Expert Panel Issues CECP Opinion on Dual-Chamber Leadless Pacemaker
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.
MHRA Updates Guidance on IVD Point-of-Care Test Devices
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 Responds to European Commission Call for Evidence on Joint Undertakings
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.
MHRA Updates List of UK Approved Bodies for Medical Devices
The MHRA has updated its list of UK approved bodies authorised to undertake conformity assessments for medical devices under the UK MDR 2002.
Swissmedic Updates Information Sheet on Clinical Investigations of Medical Devices
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.
TGA UDI Requirements for Medical Devices Commence in Australia
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 Updates SOPP on MDUFA User Fee Payments and Billing Activities
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.