The implementation of the IVDR has proven to be a very challenging task for the whole sector and all groups concerned – stakeholders, the European Commission and Member States. To meet the challenges related to the implementation, it is essential that all actors involved further step up their efforts and work closely together. The implementation plan re-assesses the implementation priorities and sets out a joint plan of the Member States and the Commission services. The latter includes specific priority actions in order to have an operational system in place before the date of application and provide key supporting elements as soon as possible.
The actions mentioned in the document have already been identified as priorities, and are already being processed. The main purpose of this paper, however, is to agree on where to focus limited resources at short notice to ensure swift delivery by the date of application. The priorities set out in this document have been identified based on the objectives of public health, patient safety and transparency, which are of key importance to the new legislation, also reflecting the most urgent needs of the stakeholders. The choice of priorities is further constrained by the fact that pandemic-related counter-measures must continue in parallel and therefore a resource balance must be found.
The priorities are split into two sets. Set A includes actions vital for devices to have access to the market (related to a framework for contingency planning and availability of notified bodies). Set B includes legislation and guidance documents that, while not obligatory, would greatly facilitate the work of the actors as well as designation of EU reference laboratories for high-risk IVDs.