The European Council has released the final versions of its Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). According to JDSupra, the Council of the European Union will vote on March 7, 2017 whether to adopt the MDR and the IVDR. That vote will be quickly followed on March 20, 2017 by a vote by the European Parliament. If adopted, the MDR and IVDR texts could be published by May 2017 and enter into force in May or June 2017. The MDR would be applicable by 2020 and the IVDR by 2022.
The final texts retain much of the same information of the current Directives released in May 2016. According to Regulatory Affairs Professionals Society (RAPS), an EU official stated that:
The content of the two regulations on medical devices and in vitro diagnostic medical devices is still the same as in the agreement reached between the Council of the EU and the European Parliament in May 2016 which has been approved by the Council on 20 September 2016… The difference between these ‘old’ documents and the ‘new’ documents is that the new documents have undergone a legal-linguistic review to make sure that the texts are coherent and equivalent in all 24 official EU languages. So in other words: the wording might have changed, but apart from corrections of some obvious mistakes and addition of necessary clarifications the new EU rules remain unchanged.
The regulations generally strengthen pre-market requirements and post-market surveillance, including establishment of a unique identification system. For example, some experts note that under the current IVD Directive, a manufacturer is able to self-certify about 80% of all IVDs on the EU market. However, when the IVDR becomes applicable five years after its publication, this ratio will flip so that approximately 80% of all IVDs on the EU market will require approval from a notified body.
JDSupra also reports that the two Regulations include transitional provisions that allow CE mark certificates issued in accordance with the current Directives to remain valid until the end of the period indicated on the certificates. According to the Emergo Group consulting company, CE mark certificates issued prior to final implementation of the new regulations in late 2019 or early 2020 will have a maximum validity of five years. CE mark certifications issued before implementation of the new regulations will expire automatically four years after the new regulations come into force.
As the Regulations will impact nearly every device manufacturer that sells products in the EU, device manufacturers are well-advised to consider their existing products and procedures in view of the Regulations to avoid future problems when marketing their devices.