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MDCG 2025-1
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MDCG 2025-1
EMDN Ad hoc procedure form
January 2025
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
| Form for the submission of proposals under the ad-hoc update procedure | Date: |
|---|
All fields in the form are mandatory except for field 13. Requests should be submitted to SANTE-EMDN@ec.europa.eu
| 1 | Name of NCA1 / NB 2 |
|---|---|
| 2 | Indication if the request is needed for the registration in the UDI-DI module of EUDAMED |
| 3 | Established need demonstration, justification as to why the request should be assessed under the ad-hoc procedure |
| 4 | Justification as to why currently existing codes cannot be utilised |
| 5 | Manufacturer’s name and authorised representative (where applicable) |
| 6 | Device name or technology name under question |
| 7 | Detailed description of the device or technology under question, including its intended purpose; |
| 8 | Indication if this is considered a novel device 3 |
| 9 | Indication if the device has or will undergo an expert panel assessment |
| 10 | EMDN Category, Group, and Type where the code could be added |
| 11 | Draft term description for the new code |
| 12 | Reference to other devices on the market with similar technology, potentially also requiring the use of this new code (where applicable) |
| 13 | Additional information (e.g. reference to other nomenclature, if any) |