Other relevant information

1. What are the UDI and device data sets to be provided in EUDAMED?

Dedicated guidelines containing information on this aspect are available at:

Further information on EUDAMED is available at:

2. Is there an adjudication process for ad-hoc exemptions foreseen for medical devices?

An adjudication process to allow for ad-hoc exemptions is not envisaged in the EU. All devices are therefore subject in principle to UDI requirements, with the only exceptions explicitly stated in the Regulation.

However, the UDI Expert Group will analyse requests for adaptation of UDI requirements to certain specific device types and recommend the Medical Device Coordination Group (MDCG) to issue dedicated guidelines, where necessary.

3. What is the EMDN and how to get access to it?

The EMDN has primarily a regulatory purpose to support MDR and IVDR requirements. It also plays a key role in MDR/IVDR device documentation and technical documentation, sampling of technical documentation conducted by notified bodies, post-market surveillance, vigilance and post-market data analysis, etc.

It is intended to support all actors in their activities under the MDR/IVDR and provides key device descriptions to patients as regards their own devices and all other devices available on the market and registered in EUDAMED.

It also aims at supporting the functioning of the European database on medical devices (EUDAMED). Among its various uses, it will be utilized by manufacturers for the registration of medical devices in EUDAMED, where it will be associated to each Unique Device Identifier – Device Identifier (UDI-DI). The EMDN is fully available in the EUDAMED public site:

The EMDN can also be accessed and downloaded in pdf and excel format following this link:

This platform is also a submission platform for any linguistic, syntax, translation feedback users and the wider healthcare community may wish to provide.

More information can be found in the EMDN Q&A endorsed by the MDCG:

4. What are technical files and the Declaration of Conformity and why are they needed?

The technical file is a set of documents providing objective evidence that the applicable MDR or IVDR requirements have been fulfilled for a specific device or group of devices. The technical documentation should include the elements set out in Annexes II and III of the MDR or IVDR.

For devices, other than class I (MDR) and class A (IVDR) devices, the technical documentation is part of the assessments conducted by the notified body of the legal manufacturer.

Upon request by a competent authority, the manufacturer should provide the technical documentation in its entirety, or a summary thereof.

With the Declaration of Conformity (DoC), the legal manufacturer declares under its sole responsibility that all medical devices covered by the signed DoC are compliant with the corresponding applicable requirements of the MDR or IVDR.

The minimum content of the DoC is provided in Annex IV of both regulations (MDR/IVDR).

5. Should custom-made devices be registered in EUDAMED?

Custom-made devices (CMD) shall be accompanied by a classification statement. This statement shall be made available to the particular patient or user identified by a name, an acronym or a numerical code.

A conformity assessment procedure covering QMS certification by a notified body is applicable to class III implantable CMDs. The registration of QMS-certificates issued for class III implantable CMD shall be entered into EUDAMED.

CMD manufacturers are exempt from device UDI registration, assignment and labeling requirements. As such, and although they must appoint a person responsible for regulatory compliance (PRRC) they are not required to register these persons in EUDAMED.

6. What are technical files for configurable devices, accessories and system and procedure packs?

Description on technical files:

According to Annex II, Section 1.1. (h):

“a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with it”

The information about the combination must be provided in the corresponding technical files of the devices to be combined.

If the combination of the devices is defined as a system or procedure pack as defined in Article 22 of MDR 2017/745, the following applies:

Those systems and procedure packs are required to be aligned to a UDI (see Annex VI, Part C; Section 6.3.1). The assignment of a Basic UDI for a system or procedural pack (as defined in article 22) is identified in Article 29, Section 2 of MDR 2017/745.

For systems and procedure packs, a statement according to Article 22, Section 2 has to be created.

In case the system or procedure packs are subject to Article 22, Section 4 of MDR:

“Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52. The natural or legal person shall assume the obligations incumbent on manufacturers.”

In case the “combination” of devices is considered a “device in its own right” a technical file and a conformity procedure is required.