The first seven months of 2022 have seen significant progress on documents, tools and new structures needed for the MDR and IVDR implementation. But with major hurdles ahead, in July it was still the problems and not the successes taking centre stage.
Three months have passed since the European Commission warned about a “grave shortage of notified body capacity,” but the situation is largely unchanged.
There is growing impetus at the highest EU levels towards ensuring the IVD Regulation is implemented as quickly and effectively as possible. Discussions at the Council of the EU have now been added to this drive.
European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.
So far, there are just six notified bodies designated under the IVDR.
The very first expert panel opinion under the Medical Device Regulation was published this summer, but quickly withdrawn. Now, a new opinion, falling under the IVD Regulation, has been made public.
The IVD Expert Panel, set up in the context of the EU’s IVD Regulation, has issued its first opinion based on a manufacturer performance evaluation report submitted by a notified body.
The seven-page document has been published on the website of expert panels on medical devices and in vitro diagnostics (Expamed) and is a review of a hepatitis E virus (HEV) test.
The advice is provided in the context of the performance evaluation consultation procedure (PECP), which is an additional element of conformity assessment by notified bodies for specific high-risk in vitro diagnostic devices (IVDR Article 48.6).
IT system deadlines are renowned for being delayed. With speculation that the full implementation of the Eudamed medical device database will be postponed again, what will this mean for stakeholders?
The timelines and deadlines for uploading information into the upgraded Eudamed database have never been easy to understand. Indeed, the complex wording and cross-referencing in Articles 123 and 113 of the Medical Device Regulation and IVD Regulation, respectively, have perplexed even the experts and lawyers over the years.
Gradually, light has been shone on Eudamed’s intricate web of compliance conditions, and the Medical Device Coordination Group has issued guidance. But in parallel, it has also emerged that there are now likely to be problems with the European Commission managing to launch the full system on its 26 May 2022 anticipated go-live date (already itself delayed by some two years compared with the date originally set).
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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