MDCG just updated its guidance document on the application of MDR requirements to legacy devices and to devices placed on the market prior to 26…
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…
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…