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…
Important deadline for legacy manufacturers: 26 September 2024
By 26 September 2024, manufacturers of legacy devices must have signed a written agreement with a notified body for MDR CE certification. Before this deadline,…
Switzerland: alignment with IVDR extension and Swissdamed implementation
On 14 August 2024, the Swiss Federal Department of Home Affairs (FDHA) announced Switzerland’s alignment with the EU extension for legacy IVDs, labelling simplification for…
MDCG on appropriate surveillance for legacy devices
On 27 May 2024, the MDCG (Medical Device Coordination Group) published an updated version of MDCG 2022-4. This document is a guidance on appropriate surveillance…
Parliament votes in favor of IVDR legacy extension and EUDAMED mandatory use
On 25 April 2024, the European Parliament voted in favour of the Proposal to extend the transitional provisions for IVDR legacy devices, introduce a gradual…
Council adopts IVDR legacy extension and sooner mandatory use of EUDAMED
On 14 February 2024, the Council of the European Union endorsed the European Commission’s proposal for a gradual roll-out of EUDAMED as well as for…
Q&A on Annex XVI transitional period
In June 2023, the Official Journal of the European Union published the common specifications for the new legacy period of Annex XVI devices. The Medical…
New flowchart on the scope of MDR legacy period extension
On 23 August 2023, the European Commission has released a new flowchart to assist manufacturers in deciding whether the MDR transitional period extension covers a…
NB Position Paper on the new MDR transition timelines
On 10 August 2023, Team-NB, the European Association of Medical Devices Notified Bodes, published a position paper on the “New MDR Transition Timelines and Notified…
European Commission updates factsheet for non-EU/EEA authorities
The European Commission has published an updated factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices. This factsheet seeks…