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…
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…
EC Proposal to extend IVD legacy period and make EUDAMED mandatory sooner
On 23 January 2024, the European Commission published a Proposal to extend the IVDs legacy period and make EUDAMED mandatory earlier than planned. With this…
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…
United Kingdom: CE marking recognition for medical devices and IVDs
Following the government’s decision to extend the CE mark recognition for a wide range of products, the UK announced that for medical devices, the deadlines…
Updated MDCG Guidance on significant changes (MDR transitional provision)
On 12 May 2023, the Medical Device Coordination Group (MDCG) published the revised Guidance on significant changes regarding the transitional provision under Article 120 of…
Feedback on amendment of common specifications for products without intended medical purpose
Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the amendment of common specifications for products without intended medical purpose.…
Team-NB: Notified Body Confirmation Letter to prove application and signed agreement
The latest developments in the implementation of the medical devices and IVD medical devices Regulations (MDR & IVDR) brought significant changes in the transitional phase…
UK: Extension of CE recognition & Registration of extended Certificates
The UK government announced that it intends to prolong the acceptance of CE marked medical devices on the Great Britain market! In Spring 2023, a…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR), the European Commission published a Q&A document to facilitate the…