Written and maintained by CASRAI Editorial Board
Last updated
This page describes products and general use; it is not medical advice.
Who this is for: clinic staff, buyers and procurement teams who hold a supplier’s CE certificate for a medical device and need to confirm it is real and current. After reading you can check the issuing body, look the certificate up in the public EU database, and tell which route applies if the device is sold in Great Britain.
How do you verify a CE certificate for a medical device?
Work in two lookups, not one. First confirm the issuing notified body is designated, using the European Commission’s NANDO information system. Then look for the certificate itself in EUDAMED, the EU medical device database, whose Notified Bodies and Certificates module is public. A PDF from a supplier is a copy; the database record is where a notified body must register certificates and later changes to them (checked 2026-11-01).
For what the mark itself means, see what CE marking is. This page covers the checking workflow only.
Where each check happens
| Check | Where | What the source says |
|---|---|---|
| Is the notified body designated? | NANDO | The Commission publishes the list of designated notified bodies in NANDO, filterable by Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). |
| Is the certificate registered, and is it still in force? | EUDAMED, Notified Bodies and Certificates module | Notified bodies must register certificates issued, amended, suspended, reinstated, withdrawn or refused, and restrictions. This information is accessible to the public. |
| Is the device sold in Great Britain? | MHRA guidance on GOV.UK | UKCA marking applies in Great Britain; CE-marked devices are accepted until stated dates. |
Step 1: confirm the notified body in NANDO
Take the notified body named on the certificate and find it in NANDO. Filter by the legislation the device falls under: MDR for medical devices, IVDR for in vitro diagnostic devices. If the body does not appear under the relevant regulation, raise it with the supplier before relying on the certificate. The Commission’s notified bodies page is the source for this list. For how designation and audits work, see notified body designation and audits.
Step 2: match the certificate in EUDAMED
The Notified Bodies and Certificates module holds the certificate records. Under the MDR and IVDR, notified bodies must register information on certificates they issue, amend, supplement, suspend, reinstate, withdraw or refuse. Notified bodies could enter data voluntarily from October 2021. Commission Decision (EU) 2025/2371 of 26 November 2025 declared the module functional, and the Commission states that from 28 May 2026 use of the module is mandatory.
A match means the certificate record agrees with what you were given: the same notified body, the same manufacturer and the same device. The status is the point of the lookup. A suspended or withdrawn certificate is recorded as such, which a copy sent by a supplier may not show. For the wider module-by-module picture, see the EUDAMED guide.
Why a record may be missing
Some elements referenced in a certificate must be registered first: the manufacturer, the authorised representative (where applicable), the system or procedure pack producer, and the Basic UDI-DI(s). If you cannot find a record, ask the supplier which notified body and certificate number to search, and treat an unverified certificate as unverified. See also the role of the EU authorised representative.
What to ask the supplier for
- The certificate, with the name of the issuing notified body, so you can run both lookups above.
- The manufacturer’s declaration of conformity; see the declaration of conformity.
- For a device from outside the EU, the name of the authorised representative.
The declaration of conformity is a separate document from the certificate; compare the manufacturer and device named in each.
UKCA marking for medical devices and supplies in Great Britain
The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices. It is not accepted in the EU, EEA or Northern Ireland. The MHRA (checked 2026-11-01, page last updated 20 February 2026) states:
- CE-marked devices are accepted on the Great Britain market until 30 June 2030 at the latest. Devices placed under the former directives (MDD or AIMDD) are accepted until the sooner of certificate expiry or 30 June 2028. Devices certified under the EU MDR or IVDR are accepted until 30 June 2030. IVDD devices are accepted until the sooner of certificate expiry or 30 June 2030.
- EU authorities no longer recognise UK notified bodies. UK notified bodies cannot issue CE certificates and became UK approved bodies. Where third-party conformity assessment is required for UKCA marking, a UK approved body is needed.
- Non-sterile, non-measuring Class I devices and general IVDs can be self-certified against UKCA, so no third-party certificate exists for them.
- A manufacturer outside the UK must appoint a UK responsible person, who must provide written evidence of the manufacturer’s authority. Devices must be registered with the MHRA before being placed on the GB market. Importers and distributors do not need to appoint a UK responsible person.
The same rules apply to UKCA marking on medical supplies as on devices generally: the question is whether the product is a medical device under the regulations, and which class and route apply. For the background to the UK change, see what changed from the MDD to the MDR.
Common mistakes
- Treating a PDF certificate as proof without looking up its status in EUDAMED.
- Checking the notified body but not the certificate, or the reverse.
- Expecting a certificate for every device. A UK self-certified Class I device, for example, has none.
- Assuming a UKCA mark is accepted in the EU or Northern Ireland. It is not.
- Assuming the US route is the same. For the equivalent US check, see what to check instead of “FDA certified”.
Frequently asked questions
How to verify a CE certificate for a medical device?
Confirm the notified body in NANDO under the MDR or IVDR, then look up the certificate and its status in the public EUDAMED Notified Bodies and Certificates module.
Is there one CE certificate verification database?
Two public sources are involved: NANDO for the notified body and EUDAMED for certificate records, per the European Commission’s pages.
What is UKCA marking for medical devices?
It is the UK product marking for certain goods including medical devices. It applies in Great Britain and is not accepted in the EU, EEA or Northern Ireland.
Does UKCA marking apply to medical supplies?
It applies to products that are medical devices under the UK regulations. CE-marked devices are accepted in Great Britain until the dates set out above.
Sources
- European Commission, Notified bodies, checked 2026-11-01.
- European Commission, EUDAMED: Notified Bodies and Certificates module, checked 2026-11-01.
- GOV.UK / MHRA, Regulating medical devices in the UK, last updated 20 February 2026, checked 2026-11-01.
