On 14 February 2024, the Council of the European Union endorsed the European Commission’s proposal…
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…
Q&A on Annex XVI transitional period
In June 2023, the Official Journal of the European Union published the common specifications for…
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…
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…
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…