Team-NB has released a document to clarify the concept of “medical device lifetime”. The Medical Devices Regulation (MDR) does not specifically provide a definition 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…
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…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are being up-classified by the Regulations and benefit from a special…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023…
IVD legacy devices: MDCG Guidance on appropriate surveillance
The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the activities to be performed by the notified bodies as part…
IVDR progressive roll-out has been officially published!
The Official Journal of the European Union (OJEU) has officially listed the amendment of the In Vitro Devices Regulation 2017/746, extending the transitional period for…