On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”). The finalised versions of the draft texts are available here and here.
Final Adoption of the texts anticipated in March
The Council of the European Union is expected to hold a vote to adopt the MDR and the IVDR on 7 March 2017. This will be followed by a vote by the European Parliament on 20 March 2017.
If the above timeline for adoption is respected, the adopted MDR and IVDR texts could be published by May 2017 and enter into force in May or June 2017. In these circumstances, the MDR would be applicable by 2020 and the IVDR by 2022.
The two Regulations will replace the current Medical Devices Directive1, the Active Implantable Medical Devices Directive2 and the In Vitro Diagnostic Medical Devices Directive3. This will result in a substantial revision of the current regulation of medical devices and in vitro diagnostic medical devices in the EU.
New transitional provisions
The two Regulations include transitional provisions permitting CE Certificates of Conformity issued by notified bodies in accordance with the current Directives, and prior to the date of the entry into force of the MDR and IVDR, to remain valid until the end of the period indicated on the certificates.
There are, however, related limitations. The medical devices to which these Certificates relate may be placed on the EU market or put into service in the EU only if, from the date of application of the relevant Regulation, they continue to comply with the relevant current Directives, and provided there are no significant changes in the design and intended purpose of the medical devices. Moreover, there will be related changes in some obligations related to the devices. The requirements of the relevant Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
We will provide more detailed information and analysis concerning the changes that the new Regulations will introduce in future blogs.
1 – Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
2 – Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
3 – Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices