You may have noticed that the UDI rules are quite complex and involve different actors.
If you are in the MedTech industry, it is even more important to be clear about which specific supervising actors exist and what their tasks are in order to avoid uncertainties and misunderstandings.
Notified Body? Competent authority? Issuing agency? Authorised representative? Get a clear overview here of what the tasks of the supervising actors in the UDI process are.
1. Notified Body (NB) are private inspection bodies notified and supervised by the state, which act on behalf of manufacturers in order to accompany and control the conformity assessment of manufacturers of industrial products of various kinds. 18 bodies are currently designated under the EU MDR (Medical Device Regulation) and 4 under the EU IVDR (In Vitro Diagnostic Regulation) to test, audit and certify medical device (now possible remotely, under justification).
The list of the Notified Body changes and grows over time:
2. Competent Authorities (CA) are supervising entities responsible for the approval of medical devices and the compliance with national statutes and regulations. They issue the Single Registration Number (SRN), and are responsible for specifying one or more Notified Bodies.
Each country within the EU and partner countries has a Competent Authority, here is their contact points.
Competent Authority of non-EU countries make the manufacturers, national associations and chambers of commerce aware of the new rules, timelines and obligations under the new Regulations.
3. Issuing Agency (IA) are accredited by the FDA or the European Commission to operate a system for the assignment of UDIs (UDI-DI Code). More exactly, they are responsible for the operation of a system for the allocation of UDI within the framework of the unique device identification for medical devices.
Issuing agencies accredited by the FDA to date are:
- GS1 (Global Standard One)
- HIBCC (Health Industry Business Communications Council)
- ICCBBA (International Council for Commonality in Blood Banking Automation), for labeling products of human origin (such as blood plasma or transplants).
Issuing agencies accrdited by the EU to date are:
- GS1 AISBL (Global Standard One)
- HIBCC (Health Industry Business Communications Council)
- ICCBBA (International Council for Commonality in Blood Banking Automation), for labeling products of human origin (such as blood plasma or transplants).
- IFA GmbH (Informationsstelle für Arzneispezialitäten), the only one based in Europe.
4. Authorised Representative (AR) are any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation; (Article 2(32) of Regulation 2017/745).
In other words, if a manufacturer not established in the EU wants to place a device in the Union Market, he must make a mandate for a sole authorised representative. The AR will have the ultimate responsibility of conformity, as it will verifiy the registration request before passing it to the national competent authority for assessment. Read more about it here.
The Article 11 of the MDR defines the responsibilities of the authorised representative:
- verify that the EU declaration of conformity and technical documentation have been drawn up.
- verify that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- verify that the manufacturer has registered the requested information in EUDAMED.
- keep copies available of all documents and make them accessible to authorities on request.
- comply with the registration obligations and verify that the manufacturer has complied with the registration obligations.
- cooperate with the competent authorities on any preventive or corrective action.
- inform the manufacturer about complaints and reports.
But the Authorised representative IS NOT allow to act within these scopes (manufacturer responsability only):
- device design
- Quality Management System
- drafting of technical documentation
If the manufacturer is not located in the EU and doesn´t comply with the obligations under the Regulations, the Authorised Representative shall be legally liable for defective devices. Therefore the manufacturer acts contrary to the obligations, the Authorised representative can terminate the mandate.
Related Posts