For manufacturers of legacy Class C IVDs that were self-declared under the EU IVDD, 26 September 2026 is one of the most important dates of…
Updated MDCG 2020-16 on IVD classification: revision of rule 7 rationale and revision of examples
The European Commission has published MDCG 2020-16 Rev. 5, the latest version of the guidance on the classification of in vitro diagnostic medical devices under…
EU Court clarifies the scope of distributors’ obligations under the MDR
On 9 January 2024, the Court of Justice of the European Union (CJEU) received a request for a preliminary ruling from the Bundesgerichtshof (German Federal Court of Justice). The…
EU PPWR applies from today 12 August 2026
The EU Packaging and Packaging Waste Regulation (EU PPWR) applies from today, 12 August 2026. While many provisions have later application dates, several requirements apply…
MDCG 2026-5 clarifies UDI assignment between manufacturers and distributors
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)…