How should a medical device website show CE and ISO 13485?
On a medical device manufacturer’s website, CE marking is shown with the notified body’s identification number if a notified body took part in the assessment; the EN ISO 13485 certificate sits with its number, scope and expiry date, and the notified body’s certificate with its record in EUDAMED. Four EUDAMED modules have been mandatory since May 28, 2026; the proposal to revise the MDR had not been adopted as of November 10, 2026.
Medical devices do not appear as a separate row in TİM’s sector table; they entered the cluster with their own guide because their certification regime is different. This guide is the detail of the medical device row of the certificate map by sector; what the declaration behind CE marking is, is explained in the EU declaration of conformity entry.
Which certificate does a medical device buyer ask for?
Three things: whether the device carries CE marking under the EU’s Medical Device Regulation (MDR, 2017/745), the manufacturer’s quality management system and, where the device’s class requires it, the certificate issued by a notified body. For the quality management system, EN ISO 13485:2016/A11:2021 is a harmonized standard under the MDR; having the certificate on the site with its number and scope answers the buyer’s first question. If a notified body took part in the conformity assessment, its identification number is shown together with the CE marking.
The second question is the transition period. For devices placed on the market under the old directives, Regulation 2023/607 extended the deadline: December 31, 2027 for class III and most class IIb implantable devices, and December 31, 2028 for other class IIb, class IIa and sterile or measuring class I devices. The extension is conditional: the manufacturer had to have a quality management system in place, to have applied by May 26, 2024 and to have signed a written agreement with a notified body by September 26, 2024. So the page of a device in transition says until when it is in transition.
How are the certificates shown on the website?
Each with its own record. CE marking sits on the device’s page; if a notified body took part, its identification number sits next to it, and that number leads the buyer to the body in NANDO. The EN ISO 13485 certificate appears on the certificate page with its number, scope, certification body and expiry date. The certificate issued by the notified body is written with the devices it covers; these certificates are recorded in EUDAMED’s “Notified bodies and certificates” module.
For a device in the transition period, the place where the site has to be honest is the date. If the device is certified under the old directive and meets the transition conditions, the page says so and until when the transition runs; presenting the old certificate as an MDR certificate promises the buyer a record that does not exist. Voluntary “CE certificates” issued by a company that is not a notified body have no legal standing; they have no place on the site.
| Item | On the website | Basis |
|---|---|---|
| CE marking, with the identification number if a body took part | Yes, on the device page | MDR 2017/745 · NANDO |
| EN ISO 13485 certificate | Yes, with number, scope and expiry date | Harmonized standard under the MDR |
| Notified body certificate | If the class requires it; with the devices covered and the EUDAMED record | EUDAMED |
| Legacy device under the old directive, in transition | If the transition conditions are met; with the transition date | Regulation (EU) 2023/607 |
| Voluntary “CE certificate” | No | Your Europe |
Where certificates belong on a medical device website
- 01CE marking, with the identification number if a body took part
- 02EN ISO 13485 certificate
- 03Notified body certificate, with its EUDAMED record
- 04Legacy device under the old directive, in transition
- 05Voluntary “CE certificate”
What should a medical device website not say?
- Showing CE without the identification number when a notified body took part in the assessment.
- A voluntary “CE certificate” obtained from a company that is not a notified body: such documents have no legal standing.
- Presenting an old-directive certificate as an MDR certificate.
- Describing the EN ISO 13485 certificate as an approval of the device itself: the certificate belongs to the manufacturer’s quality management system.
- Writing about the revision proposal as if it were in force: the proposal had not been adopted as of November 10, 2026.
What changed for medical devices in 2026?
Four EUDAMED modules (actor, UDI/device, notified bodies and certificates, market surveillance) have been mandatory since May 28, 2026, on the basis of a Commission Decision published in November 2025 (2025/2371). This brings the records of the manufacturer, the device and the certificate together in a single EU database. The Commission’s proposal to revise the MDR (COM(2025) 1023), on the other hand, had not been adopted as of November 10, 2026: it is at committee stage in Parliament, and there is no general approach in the Council. A sentence based on the proposal is not written on the site until it has been adopted and published.
The practical consequence: because the records of the manufacturer, the device and the certificate are gathered in one database, the information on the site has become comparable with what is there. The name and address in the actor record should match the site’s company details, and the model name in the device record should match the product page; any difference between the two sources becomes the first question a buyer asks the company.
How does a buyer verify the certificate?
Depending on the type of record. The notified body’s identification number is searched in NANDO; the certificate it issued and the records of the manufacturer and the device are in EUDAMED. If the EN ISO 13485 certificate was obtained from an accredited body, it can be searched in CertSearch; the four-step path is in the is a company’s ISO certificate real guide. In the Turkish market, Article 34 of Turkey’s Medical Device Regulation also sets obligations related to the Product Tracking System (ÜTS); stating on the site that the ÜTS record exists answers a Turkish buyer’s question from the start.
How are the product page and the machine layer built?
The device page carries the device’s class, the identification number next to CE and, if there is one, the UDI record together; the device’s intended purpose is written on the page with the same wording as on the label and in the instructions for use. In our reading, writing an intended purpose on the site that the label does not state means making a claim for which the device was not assessed. For a device with several models, it is clearly mapped which certificate covers each model.
In the machine layer, the certificate can be marked up as a Certification identical to the record visible on the page, knowing that Google does not use this markup for medical devices: Google supports certification markup only in merchant listings, for the EU energy label and vehicle CO2 classes. Adding a certificate to the markup that the page does not state tells neither the buyer nor the machine anything true.
A short checklist for a medical device website
- On CE-marked devices, is the identification number there if a notified body took part?
- Is the EN ISO 13485 certificate shown with number, scope and expiry date?
- Is it written which devices the notified body certificate covers?
- Is the transition date correct for devices in the transition period?
- Is a voluntary “CE certificate” left on the site?
- Does the intended purpose match the wording on the label and in the instructions?
- For the Turkish market, is the ÜTS record known and written?
The information here is not legal advice; confirm which rule applies to you from official sources and from your certification body’s current requirements.
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FREQUENTLY ASKED QUESTIONS
Which number is written next to CE marking under the MDR?
If a notified body took part in the conformity assessment, the body’s identification number. The body itself is searched in NANDO.
When did EUDAMED become mandatory?
Four of its modules (actor, UDI/device, notified bodies and certificates, market surveillance) have been mandatory since May 28, 2026.
Is the MDR revision in force?
No. As of November 10, 2026, the proposal (COM(2025) 1023) is at committee stage in Parliament, and there is no general approach in the Council; it has not been adopted.