The EU has adopted the Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) to increase safety and efficiency of medical devices available in the EU market. As part of the news legislation, a medical device database will be established, esthetic medical devices will be included and devices will be traceable, among other changes.
The regulation replaces two older directives, The Medical Devices Directive and the Active Implantable Medical Devices Directive. It was adopted April 2018, and it will enter into force in May 2020.
Below are some major changes in the new regulation.
- Economic operators consist of manufacturers, importers, distributors, suppliers, subcontractors and EU authorized representatives. Their role will change as they will hold responsibility for conformity to regulations.
- The classification system—which includes: Class III, Class IIa, Class IIb and Class I—is retained as several rules were tightened. This could result in devices moving to higher classes of product, while other products previously exempt could now be included in this scope.
- Further requirements such as technical files, common specifications, clinical evidence, conformity assessments and product labeling are now included in testing to support approval.
- The economic operators and the national authorities will undertake vigilance and post-market surveillance for further regulation requirements.
- All manufacturers and their representatives must have an appropriate quality management system.
- At least one person who has access to the manufacturer and authorized representatives will hold responsibility in regulatory compliance. The conformity of devices must be checked prior to release including confirming the accuracy of technical documents and certificates.
- As part of the regulation, notified bodies will be required to be re-designated in a series of requirements, which should be complete by the end of 2018.
- Notified bodies will have the requirement to undertake unannounced audits of manufacturers and their authorized representatives, while also providing schedules of unannounced audits to their national authorities.
- The Medical Device Coordination Group (MDCG) is a pan-EU expert committee, which the legislation created to comprise of representatives from the member states. The MDCG will assist the Commission in the implementation and operation of the new legislation.
- All medical devices will be introduced to unique device identifications (UDI), which will be placed on the label of the device, implant cards for Class III devices and potentially on the device as well for the case of reusable devices. The UDIs will be used to provide traceability of each device’s use.
- The Commission will establish a centralized EU database for the storage of information on medical devices, known as EUDAMED. EUDAMED will help facilitate the communication of pre-and-post-approval product information between economic operators, the Commission, member states and, in some instances, healthcare professionals and the public. The database is targeted to be available by the end of 2018.