The implementation of a new device identification system based on a Unique Device Identifier (UDI) is starting to become a reality. Since the New Regulations concerning medical devices were adopted on April 2017, the Medical Device Coordination Group (MDCG) and the EU UDI Working Group (UDIWG) have been drafting some guides on this topic.
As defined in the Regulation, the Unique Device Identification systemallows the unambiguous identification of a specific device on the market by means of numeric or alphanumeric characters created through a globally accepted device identification and coding standard.
This spring the MDCG published a draft clarifying the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes. In other words: certificates shall include together with the Basic UDI-DI a clear identification of the device(s) and its intended purpose as well as the declaration of conformity, among other documents.
The UDI system will be implemented together with the creation of an electronic system for Unique Device Identification (‘UDI database’), as defined in Article 28 of the new MDR. The objectives of the database are to:
· Enhance the overall transparency – through better and public access
· Avoid multiple reporting requirements
· Enhance coordination between Member States
· Streamline and facilitate the flow of information between economic operators, notified bodies or sponsors and Member States as well as Member States among themselves and with the Commission.
In spring the EU UDI Working Group also drafted a list of all the information – definition, description and format – manufacturers shall provide to the UDI database, as well as the architecture of the database.
It is important to remember that these documents reflect the latest state-of-art of the thinking on this matter and might be subject to further changes prior to final MDCG endorsement. If you wish to know more about the UDI system and the new database, please do not hesitate to contact us.
Obelis Expert Consultants, with more than 30 years of experience with EU Regulations, will gladly answer any question you may have and will assist you in safeguarding your products’ compliance.
Claudia Miralles