In July 2026, the Medical Device Coordination Group (MDCG) published MDCG 2026-5 – Position Paper on UDI Assignment Between Manufacturers and Distributors. This position paper…
Battery of IVDs, medical imaging, and radiotherapy devices excluded from removability and replaceability by end-users
On 14 July 2026, the European Commission adopted a delegated act expanding the list of exemptions to the requirements concerning the removability and replaceability of…
EU PPWR: new Packaging Regulation applicable to medical devices and IVDs
The new EU Packaging and Packaging Waste Regulation (EU PPWR) applies from 12 August 2026. While many provisions have later application dates, from 12 August…
Medical devices exempted from certain obligations under the revised MDR
On 29 June 2026, the Official Journal of the EU released new revised requirements for medical devices on the Union market. With Commission Delegated Regulation…
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…
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…
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…