EU MDR and the old MDD: what changed, from a buyer’s side

The people who had to do the work were the manufacturers. But the change altered what a buyer should be looking at on a certificate, and a surprising number of buyers are still checking the old things.

The Medical Device Regulation — Regulation (EU) 2017/745, universally called the MDR — replaced the Medical Device Directive 93/42/EEC. It applied from May 2021, after a delay, with transitional arrangements that let certificates issued under the old directive stay valid for a defined period rather than expiring on a single date.

For a manufacturer that meant re-documenting a portfolio. For a buyer it means four practical differences.

1. Some devices moved up a class

The classification rules were rewritten, and a number of device types that were self-certified under the directive now need a notified body. Software that drives clinical decisions is the clearest case: much of it was Class I and is not any more.

The practical check: if a supplier offers you a device with a self-declared conformity and no notified body number, satisfy yourself that its class still permits that. A declaration that would have been correct in 2019 can be wrong now for the same product.

2. Clinical evidence is heavier

The MDR asks for more clinical evidence, more explicitly, and asks for it to be kept current rather than assembled once. "Equivalence" to another manufacturer's device — the route a lot of older files leaned on — is much harder to use.

This is why some perfectly good products simply left the European market: the evidence work cost more than the product earned. If a device you have bought before is suddenly unavailable from its European manufacturer, this is usually why, and it is not a quality signal.

3. Every device carries a UDI

Unique Device Identification means each device carries a machine-readable identifier registered in the European database, EUDAMED. For a hospital this is genuinely useful: asset registers, recall handling and traceability all key off it.

Ask whether the units you are quoted carry a UDI and get the format. If you are building an asset register anyway, building it on the UDI rather than on your own asset numbers will save a re-key later.

4. There is a named person responsible

The MDR requires manufacturers to have a person responsible for regulatory compliance, with defined qualifications. There is also a clearer chain of obligations through importers and distributors.

What this gives a buyer is somebody to write to. On a post-market question — a field safety notice, a recurring fault, a documentation gap — that named role is a faster route than a sales contact.

What to check on a certificate now

Which regime it is issued under: MDR (2017/745) or the old MDD (93/42/EEC).
If MDD: whether it is inside its transitional validity, and what the manufacturer's plan is for the MDR certificate.
The notified body number, and that the body is still designated — designations do change.
That the specific model you are buying is named, not just the product family.
The expiry date, against your expected delivery date and not against today.

None of this makes an MDD-certificated device a bad device. A great deal of excellent equipment is still moving on valid transitional certificates. It does mean that "it is CE marked" has stopped being a complete answer, and that the follow-up question is now "under which regulation, and until when".