The Official Journal of the European Union just published the Regulation on medical devices (MDR) and the Regulation on in-vitro diagnostic medical devices (IVDR). The MDR and IVDR enter into force on 25 May 2017. Manufacturers, importers and distributors of all kinds of medical devices will be met with important changes due to the new Regulations.
As of 25 May 2017, the MDR and the IVDR will, within a transitional period of up to five years, replace the current Medical Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In Vitro Diagnostic Medical Device Directive (98/79/EC). The MDR and IVDR will have the force of law throughout the entire EU.
The Regulations differ in several important ways from the existing regimes for medical devices, active implantable medical devices and in-vitro diagnostic medical devices, and the MDR and IVDR will introduce a series of important changes with a view to modernising the existing regimes.
Below, some of the most important changes in the MDR are described. Everyone, counting manufacturers, distributors, importers, notified bodies and even Member States, has good reason to consider how the new Regulations are likely to impact their operations.
Enhanced documentation and surveillance requirements Manufacturers will have to provide further clinical data concerning their medical devices, and they will have to adjust the present data in order to place (or keep) their medical devices on the EU market. Furthermore, together with other parties in the distribution chain, manufacturers will be obliged to verify each other’s regulatory compliance and revisit existing Quality Management Systems, Post-Market Surveillance and Vigilance procedures. These obligations are particularly important, since notified bodies will be entitled and obliged to carry out unannounced inspections to verify continued compliance.
More transparency The MDR provides for stricter rules on transparency due to in particular the creation of a European database on medical devices (Eudamed). Eudamed will provide access to information on the part of the public and healthcare professionals and streamline regulatory reporting. Furthermore, Eudamed will include the Unique Device Identification (UDI), which is a system for marking and identifying medical devices to enable better traceability and recall.
Revised classification rules The classification rules have been modified, and manufacturers will need to review the updated classification rules and update their technical documentation accordingly. Notably, manufacturers will have to assess whether their medical devices may be reclassified, such as software used for decision support or monitoring being classified in a higher risk class.
Bech-Bruun’s comments The new Regulations provide for a higher level of health and safety for the EU citizens using medical devices. In consequence, manufacturers, importers, distributors, etc., must analyse the new Regulations and adjust accordingly in order to comply with the Regulations. There will be no “grandfathering”, meaning that all currently approved medical devices and active implantable medical devices must be recertified in accordance with the new requirements. The transitional period is detailed in articles 120-123 of the new MDR allowing a transitional period of up to three years (five years in respect of the IVDR).
Many tasks await the person responsible for regulatory compliance whom manufacturers are required to designate according to the MDR, in case they have not already designated one.
The MDR and the IVDR are available in all EU languages through these links: