I. Introduction and legal background
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR) introduce a "Unique Device Identification system" based on a "Unique Device Identifier" (UDI). Under those Regulations, the manufacturer is required inter alia to assign a UDI to all his devices (Articles 27(3)of the MDR and Article 24(3) of the IVDR), to place the relevant UDI carrier and relevant levels of packaging on the device (Article 27(4)of the MDR and Article 24(4) of the IVDR) and to transmit the data related to UDI to the future EU database (Eudamed) on medical devices (Article 27(3) of the MDR and Article 24(3) of the IVDR ).
In accordance with Article 27(2) of the MDR and Article 24(2) of the IVDR, the Commission shall designate one or several entities to operate a system for assignment of UDIs provided that they satisfy certain criteria listed in those articles. The entities selected will be designated via an implementing act.
II. Conditions for designation
1. Criteria for designation
In accordance with Article 27(2) of the MDR and Article 24(2) of the IVDR, the entity shall satisfy all of the following criteria:
- (a) the entity is an organisation with legal personality;
- (b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements the MDR and the IVDR
- (c) its system for the assignment of UDIs conforms to the relevant international standards;
- (d) the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions;
- (e) the entity undertakes to do the following:
- (i) operate its system for the assignment of UDIs for at least ten years after its designation;
- (ii) make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs;
- (iii) remain in compliance with the criteria for designation and the terms of designation.
2. Explanation/illustration of the criteria
The Commission considers that, in order to demonstrate and to assess compliance with the criteria (including the commitments) laid down in Article 27(2) of the MDR and Article 24(2) of the IVDR, and having due regard to the responsibility of the Commission in ensuring the good functioning of the future EU database (Eudamed), the following elements should inter alia be taken into account:
Criterion (b) [adequateness and compliance with the MDR and the IVDR]
- Procedures in place to prevent and correct deficiencies in the system for the assignment of UDIs
- Procedures in place to take necessary and timely follow-up actions, up to and including restricting the use of the company prefix or prefixes for UDI purposes
- Ensuring that entity standards on Basic UDI-DI take into account guidance provided by the Commission and the Medical Device Coordination Group
Criterion (c) [compliance with the relevant international standards]
- Compliance with standards ISO 15459-2, ISO/IEC 15459-4, ISO/IEC 15459-6
Criterion (d) [accessibility for all users]
- Provision of support to the manufacturers in the assignment of UDIs and placement of the UDI carrier
- Making available to manufacturers of appropriate and comprehensive guidelines and other materials explaining the UDI requirements within the EU and how to ensure compliance of their products
- Independence of the entity, including the absence of conflicts of interest
- Non-discriminatory and proportionate fee system, which takes into account the interests of SMEs
Criterion (e)(ii) [communication of information to the Commission and the Member States], in combination with criteria (b) and (d)
- Provision of information and involvement of the Commission in relation to planned additions or changes in the system for the assignment of UDIs
- Provision of information and involvement of the Commission in relation to changes and update of documents that the company makes available to manufacturers
- Provision of timely notification to the Commission whenever the company becomes aware of repeated and/or deliberate misuse of the organisation requirements and has restricted the use of the appropriate company prefix related to UDI
- Making available to the Commission of information related to the list of company prefixes restricted for use for UDI purposes and whether any change to the restriction status occurs
Criterion (e)(iii) [continuous compliance with the criteria]
- Ensuring continuous cooperation with the Commission services in charge of the EU database (Eudamed) including making available tools and/or services allowing to check data quality in the database
3. Terms of designation
Issuing entities are appointed for a period of five years.
The Commission may suspend or revoke the designation of an issuing entity at any time if it finds that the entity does not comply with criteria (including the commitments) laid down in Article 27(2) of the MDR or Article 24(2) of the IVDR.
III. Application for designation
The application should include the following information, material and supporting documentation:
- Name, address, and phone number of the applicant;
- Detailed information regarding the applicant's organisation, including the description of any financial or other relationship between the applicant and any manufacturer or governmental institutions or organisation;
- Detailed description of its system for the assignment of UDIs, including description of any standard or criteria applied;
- Copies of the application forms, guidelines, instructions, and other materials the applicant will send to manufacturers who plan to use the applicant's system for the assignment of UDIs. Where those materials are still under preparation, the applicant shall provide a detailed plan for adoption of those materials;
- Detailed description of the applicant's policies and procedures for determining whether manufacturers may use the applicant's system;
- Description of the applicant’s policies/procedures for dealing with manufacturers’ deficiencies in using correctly the system for the assignment of UDIs, including for monitoring corrections;
- Description of business model and fee system, with an explanation and rationale of any fee waiver or reduction available;
- Detailed description of the applicant's electronic data management system;
- Description of the tools or services made available by the applicant allowing to check data quality in the EU database (Eudamed);
- The form “Applicant’s undertakings”, signed by the applicant organisation’s legal representative in the European Union;
- Detailed information and, if available, market studies on the readability of UDI carriers which are compliant with the applicant's technical specification by the readers generally available to economic operators and healthcare institutions within the EU.
All requested documentation shall be presented in a way which is easily readable and facilitates the Commission's evaluation against the relevant criteria for designation.
All documentation shall be signed by the applicant organisation's legal representative.
Documentation shall be sent to the following email GROW-D4@ec.europa.eu by 25 January 2019.
For any further information on the selection procedure please contact:
Mr Salvatore Scalzo, Telephone: (32-2) 29-67897, e-mail: Salvatore.Scalzo@ec.europa.eu
Mr Pierre-Francois Ryelandt: (32-2) 29 -66503, email: Pierre-Francois.Ryelandt@ec.europa.eu
IV. Assessment of the applications
A Commission's panel composed of three experts from the "Health Technology and Cosmetics" Unit of DG GROW and chaired by the Head of the “Health technology and Cosmetics” Unit of DG GROW within the Commission, will be in charge of evaluating the applications received.
The Commission might ask the applicants to complement their application dossier whenever it considers that additional information is needed to verify the applicant's suitability.
Moreover, in accordance with Article 27(2) of the MDR and Article 24(2) of the IVDR, in order to minimising the financial and administrative burdens for economic operators and health institutions, the issue of readability of the UDI carrier will be subject to specific consideration.
V. Designation of the issuing entities
On the basis of the evaluation/assessment, the Commission will designate one or several issuing entities, in accordance with Article 27(2) of the MDR and Article 24(2) of the IVDR.