EUDAMED Status?

What is EUDAMED?

EUDAMED is the European Commission’s Medical Device and In Vitro Device Database. This is core to the MDR?and IVDR regulations.

What is the current EUDAMED status?

EUDAMED has three live modules, Actors, Devices, and Certificates & Notified bodies. We are still waiting for the final three modules, these are due in Q3 2024.

The currently live modules Devices, Certificates, and Actors are all working well. There is no reason not to get your company's Single Registration Number (SRN). And with the devices module working well the submission of your DIs can and should proceed ASAP. If you submit your data now, in 2024 you and your team will have a lot less EUDAMED related stress. EirMed https://eudamed.com can provide you with proven EUDAMED submission software and we can also manage your entire EUDAMED project. We offer a complete EUDAMED service from collating your data to final EUDAMED submissions and procedures for future EUDAMED management.

Why Submit to EUDAMED ASAP?

1. The UDI Device module requirements are stable, there will be no changes to the requirements before the 2027 review.
2. We expect a tsunami of company's UDI submissions in Q1/Q2 2024. This may impact the level of support available to companies. With EUDAMED fully functional in Q4 2024 the deadlines are getting dangerously close. Do not forget all serious vigilance reporting will be mandatory in EUDAMED after it is fully functional.
3. Some Competent Authorities already require companies to enter their regulation devices in EUDAMED as part of their national device registration process.

• France is asking companies to submit new MDR and IVDR products to EUDAMED
• Ireland (NSAI) also requires new regulation devices to be submitted to EUDAMED
• Finland requires manufacturers, originating in Finland, to enter new products in EUDAMED
• Others will follow, and it is possible Competent Authorities will make EUDAMED mandatory before the European Commission does.

?4.?? Some Importers and Distributors require the devices they are responsible for to be submitted to EUDAMED. We have some clients whose devices were threatened with refusal by importers because they were not in EUDAMED. This is most likely because of the legal liability importers now share with the manufacturer.

?Notified Bodies

As part of your notified body audit, you must outline your EUDAMED strategy. Having a system like EudaMed+?helps demonstrate your strategy.

The full list of notified bodies for MDR is available here and for IVDR the list is here.

Remember if you miss MDR/IVDR, and EUDAMED deadlines you,

cannot legally sell your devices in the European Union.

#eudamed #medtech #medicaldevices #regulatoryaffairs #europeancommission

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