Which are the first steps towards compliance with the MDR?
The clock is ticking for the medical device industry in the European Union, from May 2020 they will have to start complying with the new regulation in which each of the medical products will have a Unique Device Identification (UDI).
The EU regulations on medical devices (EU MDR 2017/745) and on in vitro diagnostic devices (EU IVDR 2017/746) provide the legal requirements for the Identification System (UDI) within Europe. A distinctive feature is that the regulation introduces the “basic UDI-DI” as new identifier which allows to group medical devices with similar characteristics within the EUDAMED regulatory database.
The entities designated as UDI issuers are: HIBCC, ICCBBA, IFA GmbH and GS1. GS1 has developed a new key to support the implementation of the Basic UDI-DI: the GMN. The assignment must be done by the manufacturer or authorized representative of the medical device, before the product can be submitted for registration and / or approval by the competent authorities.
EUDAMED (European Database on Medical Devices) is the database created by the European Commission for the identification of these medical devices that will include basic elements of identification of each product that has a UDI, as well as economic operators, clinical research and subsequent surveillance to marketing. This information can be uploaded through certified catalogs GDSN (Global Data Synchronization Network).
One of the first steps is the registration in EUDAMED. When is the deadline?
Some aspects of the regulation will take effect even before May 2020, and as of this date to report serious incidents and notify corrective safety actions, it is necessary that the medical device is registered in EUDAMED.
On the other hand, document MDCG 2019-5 clarifies that devices with a valid Directive Certificate that are marketed after the date of application, must be registered in EUDAMED at the time of application of the regulation.
The new categorization of the classes of devices and the new regulatory requirements for each of them, result in a great challenge for manufacturers of medical devices, that is why the sooner they begin to prepare, the more time they will have to perform the tests and avoid errors or failures when complying with the regulation.
Verifarma, as experts in serialization and traceability for the health industry, is prepared to accompany its clients in compliance with the regulation, offering the necessary consultancy during the process.