Partner at Axon Lawyers: life sciences | medical devices | IVDs | medicines | biotech | AI | REACH | Batteries | EU law | Dutch law | M&A | commercial contracts | due diligence | healthcare | (regulatory) litigation
Breaking: Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply. "This proposal for targeted amendments addresses two urgent issues. Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs, which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions. Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed. The use of Eudamed – and especially its systems for the registration of economic operators, devices and certificates – will improve transparency and provide information on devices on the EU market, helping to monitor the availability of devices. In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs." #medicaldevices #invitrodiagnostics #medtech #EUMDR #EUIVDR #EUDAMED #supplychainmanagement
Most probably we are looking for the Regulations adopted in 2017 to be implemented by 2037..... Twenty years. That's good.....
The proposal would ease some pressure on the medical device manufacturers.
Erwin Waas
7mo
Hi Erik, thanks for posting. Any idea when this will be implemented officially? Or ideas on timelines?
Annet Visscher
7mo
Thanks for sharing Erik!
Great news!
Great News
Vice - President Quality and Regulatory Affairs Indigo Diabetes. Owner Verstappen MedTech Consulting BV. daniel.verstappen2@telenet.be
7moI am happy with this proposal, as it shows that there is finally some sense of urgency at the EC. EUDAMED was initially going to be introduced when….? What bothers me with the MDR / IVDR introduction is that wherever you go, whatever you read, it’s proclaimed to be a manufacturer issue (low submission dossier quality, limited sub dossiers etc) While, all our good people on the floor, know that this is not necessarily true. Just ask yourself the question why a medical device company would submit a low quality CE marking file, or why would they hold back sub dossiers? Did you ever wondered why start-ups have a difficult time finding an appropriate MDR / IVDR NB? And finally, as the MDR / IVDR introduction was partially because we wanted to increase patient safety. So, would it not make more sense to link the EUDAMED module related to SAEs ASAP to a conditional approval for existing CE mark products with a excellent safety profile? We would catch 2 flies with one stone ( increase patient safety and medical device shortage). All in all, the MHRA began to receive reports of potential problems with PIP implants in 2002, nearly a decade before the scandal broke in March 2010. We are 2024. #Senseofurgency #patientsafety