European Commission Clarifies UDI Manufacturer Obligations Under New Regs
Distributors and importers that assume the obligations of device manufacturers also assume responsibility for unique device identification labeling, the European Commission said.
This means that distributors and importers must apply for registration as manufacturers and receive a single registration number, according to Article 16 under the EU’s Medical Device Regulation (MDR).
The entities would apply for the appropriate conformity assessment procedure and provide UDI-product registration, the Commission said in five newly released guidances that provide clarification on UDI provisions.
However, if the manufacturer is identified on the label rather than the distributor or importer, the manufacturer is responsible for meeting the UDI obligations under the quality system regulation, the Article 16 guidance clarified.
Released by the Medical Device Coordination Group (MDCG), which is comprised of representatives from all EU member states, the guidances clarify roles and responsibilities for manufacturers of medical devices, in vitro diagnostics and software as a medical device.
UDIs are required for procedure packs and systems that are not custom made devices. The Commission defines procedure packs as a combination of products packaged together and placed on the market intended for use for a specific medical purpose. A system is a combination of products packaged, either together or separately, that are intended to be “inter-connected or combined to achieve a specific medical purpose.”
The Basic UDI-DI — the key device-related information identifier in the Eudamed database — identifies systems and procedure packs as having the same group of components and the same intended purpose, regardless of the original components manufacturers. For example, first aid kits and skin traction kits would be procedure packs, while x-ray systems would be an example of a system.
According to Article 29 of Annex VI, the system or procedure pack producer is required to provide the UDI database with information, including quantity per package, indication, manner in which the pack is controlled (including the expiration date, lot number and serial number), name and address of the system or pack producer, device nomenclature code, risk class and trade name along with other requirements under Article 29.
The MDCG released a trio of guidances in May that clarified devicemakers’ responsibilities for implementing UDI systems under the new MDR. Along with guidance on the basic attributes for a device identifier (DI), the group released documents on the database and the architecture for the new UDI system (IDDM, May 7).
A separate guidance on medical device software clarifies that only software that is commercially available on its own or that constitutes a device in itself is subject to UDI requirements under the EU MDR and IVDR regulations.
The guidance specifies that a new UDI-DI is required “whenever there is a modification that changes the original performance, the safety of the software or the interpretation of data,” according to Annex VI, Part C. The modifications include new or modified algorithms, database structures, operating platforms, architecture, user interfaces and new channels for interoperability, which are considered “significant changes.”
The guidance on Basic UDI-DI notes that a UDI is required “whenever there is a change that could lead to misidentification of a device and/or ambiguity in its traceability.”
Finally, a guidance on language clarifies that information in the UDI database must be publicly available and “easily understandable by any European citizen.” The user interface of the UDI database “shall be available in all official languages of the Union,” the Commission said.
Information on special storage or handling conditions as well as warnings or precautions should be provided in English as well as in the languages of the countries where the device is marketed.
Read the UDI guidances here: www.fdanews.com/10-26-18-ECGuidances.pdf.