A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the Council and the European Parliament in April 2017. This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. The MDR was envisaged to apply from 26 May 2020 . In contrast, the IVDR has a date of application of 26 May 2022. In March 2020, the Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR. The plan listed priority actions for the Member States and Commission services, to be monitored at the level of the MDCG. The MDR joint implementation plan recognised the need to carry out a similar exercise for the IVDR. The present document therefore proposes a draft joint implementation plan for the IVDR.
The short transitional period originally envisaged for the application of the MDR (3 years) is in the interest of patient safety and in response to scandals with defective medical devices in the past. It aims to ensure that the strengthened requirements of the new framework apply as soon as possible. The IVDR pursues the same objectives but has a longer transitional period of 5 years. This is to allow more time to introduce many fundamental changes in the way the sector operates: among others, a new device classification system, much greater involvement of notified bodies in conformity assessment of devices, new regulatory structures such as the EU reference laboratories and expert panels. The European Parliament and the Council of the EU as co-legislators chose the length of the transitional period to make sure that the EU IVD conformity assessment system is reinforced as early as possible. The COVID-19 pandemic has further illustrated the need for a robust framework that ensures high standards of quality on the EU diagnostics market.
The implementation of the IVDR has proven to be a very challenging task for the whole sector and all concerned: stakeholders, the European Commission and Member States.
The IVDR assigns many implementation tasks to the Commission. Other tasks are to be done by Member States to ensure that provisions are effectively applied and enforced at national level. The MDCG was established to provide advice to the Commission and to assist the Commission and the Member States in ensuring a harmonised implementation of the MDR and the IVDR. Relevant stakeholders have observer status at the MDCG. Together with its sub-groups, the MDCG serves as a platform to facilitate cooperation between Member States and the Commission, to ensure a coordinated approach among the Member States and to collect input from relevant stakeholders. The IVD sub-group in particular has the mandate to provide assistance to the MDCG on all IVD specific issues, in collaboration with other relevant sub-groups, notably the Notified Bodies Oversight sub-group.
Member States and the Commission have, together with relevant stakeholders, been working very hard to ensure effective implementation of the new rules. Significant progress has been achieved. For example, the necessary implementing acts and administrative arrangements enabling the designation of notified bodies have been put in place. Four notified bodies have been designated as of September 2020 and further applications are being processed. The Unique Device Identifier system has been set up. The Eudamed database is under development. The IVD expert panel has been designated and experts appointed. A number of new common specifications are in development. Many guidance documents either have been published or are in a mature preparation stage.
The transition represents a significant challenge also for stakeholders such as manufacturers, notified bodies, authorised representatives and laboratories. Many are very advanced in their preparation for compliance with the IVDR, engaging in tasks such as revising documentation in line with the new requirements, recruiting new staff and updating their procedures.
Despite the efforts undertaken by all, the implementation of the IVDR remains a serious challenge. It has been compounded in 2020 by the additional efforts undertaken by all actors to respond to the COVID-19 pandemic. EU stakeholder organisations have reported that significant uncertainty hampers planning and preparation of their members for compliance with the IVDR. Nevertheless, ensuring patient access to safe and effective IVDs must be the focus of the implementation efforts. Member States and the Commission, together with concerned stakeholders, have a joint responsibility to ensure that the new legislation is operational from 26 May 2022.
To meet the challenges related to implementation of the IVDR, it is essential that all actors involved further step up their efforts and work closely together. This paper re- assesses the implementation priorities as of September 2020 and sets out a joint plan of the Member States and the Commission services, including concrete priority actions in order to have an operational system in place before the date of application.
The actions mentioned in this paper have already been identified as priorities and work on them is ongoing. The main aim of this paper, however, is to agree on where to focus limited resources in the shorter term to ensure delivery as soon as possible and 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 key to the new legislation, as well as the most urgent needs of the stakeholders. The choice of priorities is further constrained by the fact that work to combat the COVID-19 pandemic must continue in parallel and therefore a resource balance must be found.
The priorities are split into two sets. Set A includes actions that are vital for devices to have access to the market (those related to a framework for contingency planning, availability of notified bodies and designation of EU reference laboratories). Set B includes legislation and guidance documents that, while not obligatory, would greatly facilitate the work of the actors.
It should be recognised that focusing on a specific set of jointly agreed priorities could temporarily result in less resources being invested into other areas. While these short-term priorities are necessary now, they must be seen in the wider context of medium and longer-term actions for effective implementation and operation of the IVDR.
This Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. It has been endorsed in principle in the MDCG meeting of 28 May 2021. In addition to setting the priorities, the Plan will serve as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.
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