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…
Supply of medical devices in the EU: Survey & EU Authorities position
The European Commission and Members States are putting forward more steps to address the supply of medical devices in the EU. In this context, a…
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…
Annex XVI MDR: new legacy period for devices without an intended medical purpose
Today, 21 June 2023, the Official Journal of the European Union published the final text for the new legacy period of Annex XVI devices. Annex…