Thanks Christie for the first pass on this. The IVDR is the gift that certainly keeps on giving! This is going to take several reads to identify not only the new requirements but also potential impact and expectations. We will be following up with a more in-depth review, we have some hindsight from the implementation of the MDR and need to look at how this may impact the IVDR. This will have long term impact for Notified Bodies, if manufacturers press pause on the application process. If all manufacturers apply at the last minute it will create a giant bottleneck, in addition it will bunch the future renewal of certificates creating unsustainable peaks of activity for years to come. This may seem like a problem for the NBs to manage; however, if you are trying to make a change to a device or launch a new one during these peak periods there will be consequences. In the past I have said "Don't take you foot of the gas", I would now say "Time to change gear". The gear should still be a forward gear and should take into consideration how to benefit from the additional time. NBs are less likely to be understanding if there is insufficient data when there has been additional time to gather PMS data or run studies. Time to renew your strategy but not shelve it! Qserve Group #ivdr
🚨 New Proposed Amendments to IVDR with Further Extensions for Transition 🚨 The proposed new transition periods will push out the already staggered transition deadlines for legacy devices as follows: * a shorter transition period for high risk class D IVDs (31 December 2027) and * longer periods for medium risk class C and lower risk class B IVDs (31 December 2028 and 31 December 2029 respectively). The Commission has also proposed postponing the application of one of the requirements for devices manufactured and used in health institutions (notably the requirements to show that there is no alternative and equivalent commercial device on the market). This requirement is postponed to 31 Dec 2030 [beware that Q&A #4 states this is 26 May 2030, but that actual proposal states 31 Dec 2030]. This gives health institutions more time to first have an overview of available IVDs on the market. At the link provided are further links to the actual proposed legislation, a press release, a factsheet, and FAQs. I'd love to hear your thoughts on this and the other additional amendments (yes, there's more!) as you dive into the details. #medicaldevices #europeanunion #healthcare #compliance #regulatoryaffairs #diagnostics #laboratory #biotech #IVDR #clinicaltrials
Lubna Syed
7mo
Thank you Christie!
Business Development Manager @ BSI | Regulatory Services - Supporting IVD Manufacturers to Achieve Regulatory Compliance and Market Access.
7moThank you. I could not agree more!