Finland (FIMEA) makes EUDAMED mandatory. Others to follow?

Finland (FIMEA) makes EUDAMED mandatory. Others to follow?

Finland is the first of the competent authorities to make EUDAMED mandatory ahead of the European Commission deadlines. It is mandatory for medical device manufacturers that are established in Finland to submit data.

This is very interesting as we have now seen importers and now a competent authority (CA) making EUDAMED mandatory way ahead of the European Commission deadlines. If one CA makes EUDAMED mandatory, what is to stop others from doing it?

For the mandatory device registrations, FIMEA has set short deadlines:

The device information shall be submitted to the Eudamed database no later than within 60 days of the date when the device module of the Eudamed database had been put into service. 

NOTE! The IVD-legacy device shall be submitted to the Eudamed database by 25 August 2022 at the latest (applies to devices already registered in Fimea’s old device register or CERE register).

For companies still thinking about starting with EUDAMED, this is another warning that your timelines may not be shared by regulators or the market in general. As we have said many times you need to get your data in ASAP to avoid potentially stressful deadlines being imposed on you.

One last note on this point if you decide to wait until EUDAMED is fully functional, Q4 2023, then please remember from Q1 2024 all serious vigilance incidents must be reported via EUDAMED. To report an incident in EUDAMED your Device data must already be submitted, otherwise, you can submit your vigilance reports, this is why Dec 2023 should be considered a hard deadline for getting your data into EUDAMED.

For all the information from FIMEA click here

If you require any assistance with your EUDAMED submissions, from software and training to consultancy please do contact us.

For everything, EUDAMED visit eudamed.com

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