December 14, 2021

[FEATURED] Timelines And Deadlines For Stakeholders To Submit Information To EU’s Eudamed Database

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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December 7, 2021

[FEATURED] Are Latest Challenges Threatening To Push Eudamed Launch Date Into 2023?

While nothing is official yet, it seems that the EU is likely to struggle to have two of the six Eudamed modules ready on time. Might this mean a further delay, or will the system be officially launched without them? 


The clinical investigations and the market surveillance modules of the new version of the EU medical device database, Eudamed, are reported to be causing the biggest challenges when it comes to setting up all six modules so that the entire database can be launched in 2022.

“We may even see Eudamed being launched officially with one or both missing, Ronald Boumans, senior consultant, regulatory affairs Emergo by UL, speculated.

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November 30, 2021

[FEATURED] FDA-Backed Tumor Mutation Database Gives Diagnostics Developers Another Premarket Submission Tool

The US FDA on 7 October recognized a portion of the Oncology Knowledge Base, or OncoKB, which test makers can use as they work to complete premarket submissions. It’s the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases.


Diagnostics developers now have another tool backed by the US Food and Drug Administration that they can lean on as they work to complete premarket submissions to the agency.

The FDA on 7 October recognized part of a tumor mutation database compiled by the Memorial Sloan Kettering (MSK) Cancer Center. The Oncology Knowledge Base, or OncoKB, is the first database of somatic variants in cancer to be listed in the agency’s Public Human Genetic Variant Databases (PHGVD).

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November 23, 2021

[FEATURED] MRA Or Not, Swiss Medtech Industry Urges Maximum Convergence With EU MDR

Swiss domestic medtech manufacturers reluctantly accept Switzerland’s new status as a third country to the EU, but the Swiss industry is anxious that new national regulations do not impose higher hurdles than the EU MDR. At present, there is a risk of that happening.


Swiss medtech manufacturers appear to have taken a pragmatic view of the country’s newfound status as a third country to the EU, in the months since the EU Medical Device Regulation took effect. In the absence of the mutual recognition agreement (MRA) with the EU, the MDR does not apply directly in Switzerland, as the medical device directives did, so Switzerland enacted its own national Medical Device Ordinance (MedDO/MepV).

The revised Swiss medical device legislation was put in place to maintain Switzerland’s orientation towards both the MDR and the future IVD Regulation, regarding product quality, safety and efficacy. At some point in the future, a Swiss referendum might lead to a situation where mutual recognition and free market access are once again in place for both parties.

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November 16, 2021

[FEATURED] Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap

The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.


The urgency of having the necessary structures in place, including notified bodies, so that manufacturers can comply with the IVD Regulation, continues to be emphasized by all stakeholders in the EU IVD sector.

Accompanying this is a general sense that there has been a lack of transparency about when additional designations will be made, which hinders companies’ preparations.

The latest figures from the European Commission show that progress is being made, but not as quickly as the sector would like.

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