From tomorrow, 28 May 2026, the use of four key EUDAMED modules becomes mandatory under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic…
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26 May 2026: last day for Class C IVDs to apply with a notified body to maintain the EU legacy status
Today, 26 May 2026, marks an important deadline for manufacturers of legacy Class C IVDs under the IVDR. To maintain access to the EU market…
UK MDR consultation on pre-market medical devices regulation
On 11 May 2026, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a survey as part of its ongoing reform of pre-market medical…
New requirements for conformity assessment activities under EU MDR and IVDR
On 5 May 2026, the Official Journal of the EU released Commission Implementing Regulation (EU) 2026/977. This Regulation lays down uniform quality management and procedural…
Consultation on medical devices exempted from removability and replaceability requirements under EU Battery Regulation
The European Commission is seeking views on the proposed delegated regulation on derogations for the removability and replaceability of portable batteries. The list covers in…
EU guidance documents updated in April 2026
In April 2026, the European Commission issued new versions of several guidance documents for compliance of medical devices and IVDs with the EU MDR and…
Swiss authority announces inspections of PMS documentation
On 23 April, Swissmedic announced that they will be conducting a focus campaign of the requirements for post-market surveillance (PMS) of higher-risk medical devices. The…
New submission requirements for medical devices in Canada from April 2026
As of April 2026, Health Canada has implemented the Regulatory Enrolment Process (REP) as the mandatory submission pathway for medical device licence applications and related…
EU pilot programme to support breakthrough medical devices and in vitro diagnostics
The European Medicines Agency (EMA) launched a pilot programme to support breakthrough medical devices and diagnostics with a significant positive clinical impact. This initiative aims…
EU harmonised standards for sterilizers for medical purposes and hearing aids
The Official Journal of the EU published new harmonised standards for sterilizers for medical purposes and hearing aids. With Commission Implementing Decision (EU) 2026/760 published…
US FDA Quality Management System Regulation: alignment with ISO 13485:2016
In January 2024, the US Food and Drug Administration (FDA) published a final rule amending the Quality Systems (QS) regulation for medical devices. The rule entered into force on 2 February…
EU Battery Regulation for medical devices and IVDs: manufacturers and producers
The EU Battery Regulation 2023/1542 is the legislative framework for all types of batteries in the European Union, whether sold separately, built-in, or supplied with…
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