The US Food and Drug Administration (FDA) has opened the annual establishment registration renewal period for medical device companies marketing their devices in the United…
UK government confirms indefinite recognition of CE marked medical devices and IVDs
Today, 21 October, the UK government confirmed the indefinite recognition of CE marked medical devices and IVDs in Great Britain. This decision comes a few…
Swissdamed October updates: importers and CH-REP mandate validity
The gradual roll-out of Swissdamed continues as October 2026 brings two new functions: Linkage of importers to the devices they import. Automatic expiration of mandates…
EUDAMED deadline to register medical devices and IVDs: 28 November 2026
The end of next month marks another important deadline for medical devices and IVDs on the Union market. In case the first unit of a…
New EU Standardisation Regulation: what changes for European standards
On 6 October 2026, the European Commission proposed a revision of the current European standardisation system. With the new Proposal for a Regulation on European…
26 September 2026: EU deadline for legacy class C IVDs
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…