On 22 February 2017, the Council published their positions on the in vitro diagnostic medical devices and medical devices Regulations. The texts can be found here (for IVDs) and here (for medical devices). With the publication of these positions, the Council is now expected to vote on 7 March 2017 to formally adopt the new Regulations.
In terms of next steps, votes by the European Parliament plenary are expected to follow in April 2017 and the publication of the Regulations in the Official Journal is anticipated within six weeks of the Parliament vote. The Regulations will be fully applicable three years after publication for medical devices and five years after publication for in vitro diagnostic medical devices.
MedTech Europe recognises the considerable work done by the legal linguist services in eliminating inconsistencies and typos in the official English version. A first look at the text indicates that a number of issues have been addressed since the August 2016 version. For example, the transitional provisions for both texts have been cleaned up and clarified, in particular with respect to the validity of certificates, responsibilities of notified bodies and the Eudamed database. Specifically for IVDs, conformity assessment has been made clearer. For medical devices, some elements related to clinical evaluation have been cleaned up and clarified.
Going forward, ahead of the final publication of the texts, it is important to have a clear implementation plan to ensure that all actors - including the authorities, notified bodies and economic operators - can successfully transition to the new Regulations. In this regard, we welcome plans by the European Commission and Competent Authorities to consult stakeholders to develop an implementation roadmap. To contribute to this exercise, we have identified eight priority areas for each Regulation which includes for both Regulations the putting in place of a fully functioning notified body system and of the Eudamed database. Specifically for IVDs, examples of priority areas where further work is needed in the implementation phase include classification, conformity assessment and clinical evidence. For medical devices, examples include clinical evaluation, common specifications and the vigilance system.