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MDCG 2026-4: new responsibilities for SS(C)P management in EUDAMED
In June 2026, the MDCG published a position paper on the management of the Summary of Safety and Clinical Performance (SSCP) and of Summary of…
Full list of newly EU harmonised standards for medical devices
On 17 June 2026, the Official Journal of the EU released Commission Implementing Decision (EU) 2026/1231. This Decision amends the annex to Implementing Decision (EU)…
New harmonised standard: updated EU authorised representative symbol to EU-REP
Following today’s publication in the Official Journal of the EU, EN ISO 15223-1:2021/A1:2025 is officially harmonised. ISO 15223-1:2021 (Amd. 1:2025) was updated by the International…
Swissdamed device registration becomes mandatory from 1 July 2026
From 1 July 2026, manufacturers of medical devices and IVDs on the Swiss market will have to ensure that their devices are registered in Swissdamed.…
EUDAMED becomes mandatory on 28 May 2026
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…
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…
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