Both MDR and IVDR now apply, wheater or not it is a reason to celebrate is unclear, but at least we have certainty around the date of application for both regulations. No more delays, no more rumours, the regulations now apply. EUDAMED, the European Medical Device Database, is central to these regulations, and we are now eagerly waiting for EUDAMED to become fully functional, effectively its date of application.
Why is “EUDAMED fully functional” important?
EUDAMED is fully functional after all planned modules are live and six months after a notice has been placed in the official journal, Q4 2023 is when this happens. Why is this so important? When EUDAMED is fully functional then all vigilance reporting happens in EUDAMED, to add any vigilance reports the device data must be in EUDAMED. Following various transition periods, all medical devices on sale within the European Union must be submitted to EUDAMED.
Until EUDAMED is fully functional the device data submissions are voluntary but remember you cannot add vigilance reports if your device data is not there first so our advice is to get your data into EUDAMED ASAP. Failure to submit your data in advance of it being fully functional can bring additional risks, in particular, if you miss the transition deadlines then you cannot legally sell your products in the EU, a disastrous outcome.
What has this to do with the importer? What problems?
The importer is supposed to check EUDAMED for the device data, does it exist, is the data correct, etc. but if EUDAMED is voluntary why worry? We all heard the anecdotical evidence that importers were insisting on non-EU manufacturers submitting their data as soon as possible. In recent weeks this is exactly what two of our clients were faced with a problem, one US and one Swiss company, “if your data is not in EUDAMED we are not importing your products”. This put huge pressure on these companies then they had to very quickly collate their device data and get it to us, Eudamed.com, for validation and final submission to EUDAMED.
These companies had a very simple choice: get your data into EUDAMED or stop selling via this importer. A big problem and a lot of added stress.
Even though the European Commission has said EUDAMED is voluntary, Authorised representatives and Importers can insist that companies submit their data asap, otherwise, companies may need to find new representatives for their products on the EU market. Issues or delays in complying with your importer’s demands could damage your company’s market share.
Is it possible distributors could insist on similar submissions in the very near future? How much pressure would that put on manufacturers?
There is no reason to delay submitting your device data to EUDAMED. Submitting your validated data takes time, to get the data collated, ensuring it meets the EUDAMED rules, and finally submitted to EUDAMED can be done now, there is no reason to wait. While not all importers are pushing hard to see their manufacturer’s data in EUDAMED, why risk your relationship? Why not get your data submitted now? After all, submitting your device data to EUDAMED is a task you will have to do either way.
Eudamed.com can help you with the required EUDAMED data submission software we can also help with exclusive EUDAMED training and consultancy.
You should also remember that EUDAMED is not necessarily a once-off data submission requirement; maintenance and data updates may also be required which means you will need new procedures for managing EUDAMED, we can help with these tasks.