According to the Medical Device Regulation (MDR) which is about to be fully implemented, systems and procedure packs will be subject to certain obligations in order to be compliant with the legislation.
It is the Article 22 of the Regulation which provides us with information about the obligations of the system of procedure pack manufacturer i.e. “the natural or legal person who combines medical devices bearing a CE marking alone or together with other products which are not devices and are compliant with the respective legislation which apply to them in order to place that combination on the market as either a system or a procedure pack”.
According to the Article 30 of the MDR the system or procedure pack producer will have to apply for registration to the Competent Authority and obtain a Single Registration Number (SRN) that will be required on various occasions and especially to register these specific medical devices in the Unique Device Identification (UDI) database.
Thus to comply with the New Regulations, devices that are not custom made will have to undergo the UDI registration aforementioned.
To do so, system or procedure pack producers will have to assign their devices a Basic UDI-DI and to submit it to the UDI database together with other core data elements referred to in Part B of Annex VI of the MDR detailed by the Medical Devices Coordination Group in its Document MDCG 2018-4to be assigned their own UDI (composed of the UDI-DI and the UDI-PI).
The MDCG also addressed the question of the specific consideration on UDI rules for medical devices software as they are also concerned by the UDI requirements of the New Regulations.
As systems and procedure packs, medical device software need to be assigned a Basic UDI-DI and a UDI-DI by their producer but the MDCG goes further in its guidance by providing us with key information regarding changes to UDI-DI.
According to the MDCG, medical device software would need a new UDI-DI whenever:
· The Basic UDI-DI of a software will be subject to changes;
· The original performance, safety or the interpretation of data will be subject to changes;
· The name or trade name, version or model number, critical warnings or contra-indications, user interface language will be subject to changes.
However, contrary to changes in the function of the software or major revisions, minor software revisions will only trigger a new UDI-PI.
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.
Manon Prado