EU medical device regulation to enter into force
BRUSSELS, Belgium: The European medical device regulation (MDR; Council Regulation (EU) 2017/745) will enter into force on 26 May 2020, replacing the active implantable medical device directive (Council Directive (EEC) 90/385) and medical device directive (Council Directive (EEC) 93/42). By then, all medical device manufacturers will need to be compliant and distributors will have a number of new obligations.
Firstly, under the MDR, distributors will be obligated to verify that the devices they distribute meet the following requirements:
- The device has received a CE marking and an EU declaration of conformity of the device has been drawn up.
- The labels and instructions for use are provided in the official languages of the member states in which the device is made available (or in languages accepted by those member states).
- For imported devices, the importer’s name, place of business and address are indicated on the device or in the accompanying documentation.
- Where applicable, a unique device identifier (UDI) has been assigned by the manufacturer.
A distributor can show that these requirements are verified through representative sampling. In addition, as long as a medical device is under the distributor’s responsibility, the distributor must make sure that it is stored and transported in accordance with the manufacturer’s recommendations.
When a device does not comply with the above requirements, a distributor should not make it available on the market. In such a case, the distributor must alert the manufacturer, authorised representative or importer. When the distributor suspects that the device has been falsified or that there is a serious risk to health, the distributor has the additional obligation to inform the authorities. Furthermore, distributors should keep a register of complaints, non-conforming devices, recalls and withdrawals.
Secondly, the MDR introduces a system of UDIs, unique codes for each device that must be affixed to the label or packaging and aim at enhancing the device’s identification and traceability. The UDI system will allow stakeholders to access basic information on devices through the European database on medical devices (EUDAMED), which will function as a registration, collaboration, notification and dissemination database. In addition, EUDAMED will include information on clinical investigations, certification and market surveillance.
Importers, manufacturers and authorised representatives will have to register themselves with the database too. Importantly, distributors are not required to register themselves or the devices they distribute on EUDAMED. Their role is limited to assuring that a UDI has been assigned and affixed to each individual device.
More information on the MDR and its implications for distributors can be found in the European Commission's Factsheet for Authorised Representatives, Importers and Distributors of Medical Devices and In Vitro Diagnostic Medical Devices.