In short:
The existence of a Quality certificate does not automatically mean that it must be entered during the manufacturer’s UDI submission. The Certificate section of the UDI registration is not a complete list of all certificates held by the manufacturer. For specific device configurations, EUDAMED requires information on the relevant Product certificate.

Product certificates

Product certificates include in particular:

• EU technical documentation assessment certificate (Annex IX Chapter II)
• EU type-examination certificate (Annex X)
• EU product verification certificate (Annex XI Part B)

The scope of a Product certificate is product-related. The devices concerned can be identified through the corresponding Basic UDI-DIs within the Certificate Scope.

Quality certificates

Quality certificates include, for example:

• EU quality management system certificate (Annex IX Chapter I)
• EU quality assurance certificate (Annex XI Part A)

The scope of a Quality certificate can be considerably broader. It may include device groups, Risk Classes, Device Names or Catalogue/Reference Numbers and does not necessarily list every individual Basic UDI-DI held by the manufacturer.

Important:
No Product certificate information in the manufacturer’s UDI submission does not mean that no certification is required. A Quality certificate may still be required under the applicable MDR conformity assessment route. It is registered by the Notified Body in the Notified Bodies & Certificates Module.

Practical example:
A Quality certificate may cover a specific device group without listing every Basic UDI-DI within that group individually. This therefore does not automatically create a direct Certificate link to every individual Basic UDI-DI.

Type of Certificate
Required where the applicable device configuration requires Certificate Information.

Notified Body ID
Required.

Certificate ID
Optional for this submission.

Revision Number
Optional for this submission.

MDR Class I / IIa

Implantable: depending on device

IIb implantable exceptions: Not applicable

UDI submission:
No Product certificate information is required under BR-UDID-109.

MDR Class IIb – non-implantable

Implantable: No

IIb implantable exceptions: Not applicable

UDI submission:
An EU type-examination certificate (Annex X) must be provided if the device is covered by such a certificate. If no applicable Type Examination Certificate exists, no Product certificate information is required.

MDR Class IIb – implantable with exception

Implantable: Yes

IIb implantable exceptions: Yes

UDI submission:
For the corresponding Annex IX route, no TDA Product certificate information is required. However, if the device is covered by an EU type-examination certificate (Annex X), the corresponding Certificate Information must be provided.

MDR Class IIb – implantable without exception

Implantable: Yes

IIb implantable exceptions: No

UDI submission:
An EU technical documentation assessment certificate (Annex IX Chapter II) or an EU type-examination certificate (Annex X) must be provided, depending on the conformity assessment route actually applied.

MDR Class III

Implantable: Yes / No

IIb implantable exceptions: Not applicable

UDI submission:
An EU technical documentation assessment certificate (Annex IX Chapter II) or an EU type-examination certificate (Annex X) must be provided, depending on the conformity assessment route actually applied.

Case 1: Implantable = Yes, IIb implantable exceptions = No

For a Class IIb implantable device to which no relevant exception applies, technical documentation assessment for the individual device is generally relevant under the Annex IX conformity assessment route.

In this case, the corresponding EU technical documentation assessment certificate (Annex IX Chapter II) is the relevant Product certificate.

An existing EU quality management system certificate (Annex IX Chapter I) does not replace this Product certificate requirement.

Case 2: Implantable = Yes, IIb implantable exceptions = Yes

Where the Class IIb implantable device falls under an applicable exception, the corresponding Annex IX route does not impose the same requirement for technical documentation assessment for every individual device.

In this scenario, the manufacturer’s UDI registration therefore does not include the corresponding TDA Product certificate information.

However, if the device is actually covered by an EU type-examination certificate (Annex X), the corresponding Certificate Information must still be provided.

Practical point:
Before UDI submission, manufacturers of Class IIb implantable devices should verify not only the Risk Class but also Implantable, IIb implantable exceptions and the conformity assessment route actually applied.

Note on the current documentation status:

The published Business Rule BR-UDID-109, Production v2.27.0 still partly uses the wording “sutures and staples”. The EUDAMED M2M documentation already uses the broader term “IIb implantable exceptions”. The current MDR legal framework should therefore also be considered when assessing the applicable regulatory exception.

1. Check the Risk Class
Is the device Class I, IIa, IIb or III?

2. Check Implantable
For Class IIb devices, the Implantable property is decisive for the next step in the Certificate logic.

3. Check IIb implantable exceptions
For implantable Class IIb devices, determine whether a currently applicable regulatory exception exists.

4. Check the Conformity Assessment Route
Determine whether Annex IX or Annex X was actually applied and which Product certificate covers the device.

5. Do not automatically submit every available certificate
A Quality certificate should not be confused with the Product certificate information required by BR-UDID-109 for specific device configurations.

Conclusion

For EUDAMED UDI registration, the decisive question is not:
“Which certificates does the manufacturer hold?”

The relevant question is:
“Which Product certificate information does EUDAMED require for this specific device configuration?”
Quality certificates may be mandatory under the MDR conformity assessment process without automatically being entered in the Certificate section of the manufacturer’s UDI submission.

Must an EU quality management system certificate be entered during EUDAMED UDI registration?

Not merely because it exists. BR-UDID-109 requires Product certificate information for the device configurations defined by the rule. Quality certificates are managed in the Notified Bodies & Certificates Module.

Does “no Certificate Information required” mean that no Notified Body certification is required?

No. The Certificate requirements of the UDI registration must be distinguished from the MDR conformity assessment requirements applicable to the device.

Which information is required when Certificate Information must be provided?

In particular, Type of Certificate and Notified Body ID. Certificate ID and Revision Number are optional for this submission.

Why is “IIb implantable exceptions” so important?

For Class IIb implantable devices, the applicable exception affects whether Product certificate information is required for the conformity assessment route actually applied.

Scope of this article:
This article covers regular MDR devices registered in the EUDAMED UDI/Devices Module. Legacy Devices, IVDR devices, Custom-made Devices and other special scenarios are outside its scope.

Note:
EUDAMED documentation and Business Rules are updated periodically. Manufacturers should always verify the latest system documentation and the regulatory requirements applicable to the specific device before registration.