Mandatory EUDAMED. Successful? What next?

On 28 May 2026, EUDAMED became mandatory. We are only a couple of weeks in, and the system has already come under severe pressure from the sheer volume of data and submissions. We have seen significant delays in M2M uploads caused by submission queues.

The #EUDAMED support and M2M teams have been excellent, given the pressure they are under. Plenty of people in the industry are quick to criticise EUDAMED and the effort so far — but the team behind it is working exceptionally hard to make this a success. Many of them have been working on it since 2017, so now is the time to give credit where credit is due: this is one of the European Commission’s largest IT systems, and it is holding up well under a genuine deluge of data.

Consider the scale. Well over 750,000 UDIs have been added in just the past few weeks, bringing the total to almost 2.5 million. That is huge. And think about what sits behind it: if those 750,000 devices are made available across all 30 EU and EEA markets, that is around 22,500,000 market entries in a single table. That is not a spreadsheet. That is real big data.

And this is only the start. There are most likely another 2,000,000+ devices still to come, and EUDAMED will be under sustained pressure over the next six months.

The legal backdrop matters here. The mandatory date was triggered by Commission Decision (EU) 2025/2371, published in the Official Journal on 27 November 2025, which declared the modules functional and started the six-month countdown to 28 May 2026. Devices placed on the EU market from that date must be registered before they are sold. Devices already on the market have until 27 November 2026 to be registered.

That November deadline is exactly where the gamble lies. The smart people in the room are getting their data into EUDAMED now. The gamblers will wait until October and November, when there will be a frantic push from everyone who left it late — racing to get their data in before they are legally blocked from selling in the EU. In my opinion, targeting November for your EUDAMED uploads is a serious market-access gamble.

Now what?

“EUDAMED is mandatory, our data is in, so we can relax.” That is what some people are thinking. It is the wrong instinct.

Now you have to maintain the data, keep it correct, and make sure your Notified Body knows exactly what you have in there — because at your next audit, they will ask for proof. In practice, that means:

Certificate expiry monitoring, every month.

PRRCs actively monitor EUDAMED to ensure no one is counterfeiting your products or misusing your certificate numbers.

And it does not stop with manufacturers. Importers, Authorised Representatives, Distributors and procurement teams all have their own EUDAMED obligations now — their own data to check, their own lists to keep current, and their own need to prove they are on top of it. More on each of them below.

EUDAMED’s work is only just starting. So is yours.

Stop printing thousands of PDFs

I have seen posts recently telling people to print everything out of EUDAMED to PDF, so they can hand Notified Bodies thousands of pages of “proof” that their data exists. The proof is important, and it is required, but spending hours and days assembling current, dated data in an awful format is a waste of RA time. Worse, it is an exercise you will have to repeat every year to keep the data current.

Have a look at EudaMedCheck.com. The hard work is done for you, for pennies compared to RA day rates.

Importers, Authorised Representatives and Distributors

You have to check every device you represent — a huge task — and you will have to prove you did it. EudaMedCheck.com will save you weeks of pain. Send us your lists of UDIs, and we will return all the data and certificate expiry dates you need, refreshed every month, including early warnings for any certificates in your portfolio that are about to expire. It is a genuine early-warning system.

Procurement, hospitals and medical practices

You need to validate the products in your tender submissions and your stock rooms — confirming they are correct and the certificates are in date. Again, take a look at what we provide for pennies; it will save you days of effort.

SwissDaMed and #CH-Reps

Are you really going to spend weeks pulling data out of EUDAMED every time a client updates their portfolio? Or would you rather someone hand you everything you need for your client submissions?

CH-Reps and manufacturers: if you need help with SwissDaMed or turning EUDAMED into clean, human-readable data, get in touch. We have you covered.

Eudamed.com and EudaMedCheck.com