BAKGRUNN (fra europaparlaments- og rådsforordningen)

(1) Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a regulatory framework to ensure the smooth functioning of the internal market as regards medical devices and in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users. At the same time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of quality and safety for medical devices and in vitro diagnostic medical devices in order to meet common safety concerns as regards such devices. Furthermore, both Regulations significantly reinforce key elements of the previous regulatory framework set out in Council Directives 90/385/EEC (5) and 93/42/EEC (6) and in Directive 98/79/EC of the European Parliament and of the Council (7), such as the supervision of notified bodies, risk classification, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, and require the setting up of the European database on medical devices (Eudamed) to enable transparency and traceability in respect of medical devices and in vitro diagnostic medical devices.

(2) Regulations (EU) 2017/745 and (EU) 2017/746 require the Commission to set up, maintain and manage Eudamed, which includes seven interconnected electronic systems. The development of four electronic systems has been completed and the completion of two further electronic systems is expected in 2024. However, the development of the electronic system on clinical investigations and performance studies has been significantly delayed due to the technical complexity of the requirements and workflows to be implemented.

(3) Pursuant to Regulations (EU) 2017/745 and (EU) 2017/746, the obligations and requirements that relate to Eudamed are to apply from a certain date once the Commission has verified the full functionality of Eudamed and published a notice to that effect. The delayed development of the final electronic system therefore holds back the mandatory use of the individual electronic systems that are available.

(4) The use of the electronic systems that are completed or that are about to be completed would largely support the effective and efficient implementation of Regulations (EU) 2017/745 and (EU) 2017/746, decreasing the administrative burden for economic operators. A gradual roll-out of the individual electronic systems of Eudamed should therefore be allowed once their functionality has been verified in accordance with the procedure laid down in Regulation (EU) 2017/745.

(5) Having regard to the gradual roll-out of Eudamed’s electronic systems and to avoid overlapping periods of registration in national databases and in Eudamed, the dates of application of the obligations and requirements that relate to Eudamed and the dates of application of the corresponding national registration requirements based on Directives 90/385/EEC, 93/42/EEC and 98/79/EC should be aligned.

(6) Due to the delay of the development of the electronic system on clinical investigations and performance studies, the timeline for the application of the coordinated assessment for clinical investigations and performance studies should also be adapted, keeping the approach that Member States should first have the possibility to opt-in before participation in the coordinated assessment becomes mandatory for all Member States.

(7) Despite the increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/746, the overall capacity of notified bodies is still not sufficient to ensure the certification of the large number of in vitro diagnostic medical devices which are to undergo conformity assessment involving a notified body under that Regulation.

(8) The number of applications for conformity assessment of in vitro diagnostic medical devices submitted by manufacturers and the number of certificates issued by notified bodies to date indicate that the transition towards the regulatory framework established by Regulation (EU) 2017/746 has not progressed in a way that would ensure a smooth transition to the new rules under that framework.

(9) It is very likely that many safe and critical in vitro diagnostic medical devices, which are essential for the medical diagnosis and treatment of patients, would not be certified in accordance with Regulation (EU) 2017/746 before the end of the transitional periods. This leads to a risk of shortages, especially of highest-risk (class D) devices, by the end of the current transitional period on 26 May 2025. It is therefore necessary to ensure that there is an uninterrupted market supply of in vitro diagnostic medical devices in the Union.

(10) In order to ensure a high level of protection of public health and patient safety, while safeguarding the smooth functioning of the internal market, as well as to provide legal certainty and avoid potential market disruption, it is necessary to extend further the transitional periods laid down in Regulation (EU) 2017/746 for devices covered by certificates issued by notified bodies in accordance with Directive 98/79/EC and for devices which are to undergo conformity assessment involving a notified body for the first time under Regulation (EU) 2017/746. To achieve those objectives, the extended transitional period should concern all device classes so as to guarantee a manageable distribution of workload across notified bodies in time, and to avoid any impediment to the certification process.

(11) The extension should be of sufficient duration to give manufacturers and notified bodies the time necessary to carry out the required conformity assessments. The extension should aim to ensure a high level of public health protection, including patient safety and an avoidance of shortages of in vitro diagnostic medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements.

(12) The extension should be subject to certain conditions to ensure that only in vitro diagnostic medical devices that are safe and for which the manufacturers have taken certain steps to transition towards compliance with Regulation (EU) 2017/746 are to benefit from the additional transitional period.

(13) To ensure a progressive transition to Regulation (EU) 2017/746, the appropriate surveillance regarding in vitro diagnostic medical devices benefiting from the transitional period should be transferred from the notified body that issued the certificate in accordance with Directive 98/79/EC to a notified body designated under Regulation (EU) 2017/746. For reasons of legal certainty, the notified body designated under Regulation (EU) 2017/746 should not be responsible for conformity assessment and surveillance activities carried out by the notified body that issued the certificate.

(14) As regards the periods needed to allow manufacturers and notified bodies to carry out the conformity assessment in accordance with Regulation (EU) 2017/746 of in vitro diagnostic medical devices that are covered by a certificate or a declaration of conformity that was issued in accordance with Directive 98/79/EC, a balance should be struck between the limited available capacity of notified bodies and ensuring a high level of patient safety and public health protection. Therefore, the length of the transitional period should depend on the risk class of the in vitro diagnostic medical devices concerned, so that the period is shorter for such devices belonging to a higher risk class and longer for devices belonging to a lower risk class.

(15) Having regard to the impact that shortages of certain medical devices and in vitro diagnostic medical devices can have on patient safety and public health, a prior notice mechanism should be introduced to enable competent authorities and health institutions, in particular, to take mitigating measures where necessary to ensure patient health and safety. Therefore, where manufacturers anticipate, for any reason, the interruption or discontinuation of supply of medical devices or in vitro diagnostic medical devices and it is reasonably foreseeable that such interruption or discontinuation can result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer should inform the relevant competent authorities as well as the economic operators to whom they directly supply such devices and, where applicable, the health institutions or healthcare professionals to whom they directly supply such devices, thereof. The risk of serious harm to patients or public health can, for example, be due to the relevance of such devices for ensuring essential healthcare services in one or more Member States, the dependency of patient health and safety on the continuous availability of such devices in one or more Member States, or the absence of suitable alternatives, also in light of the expected length of the interruption, the quantities of devices already made available on the market and available stocks or timelines for procuring alternatives for such devices. The information should be provided by the manufacturer and other economic operators in the downstream supply chain until it reaches the relevant health institutions or healthcare professionals. As the risk of shortages of such devices is particularly relevant during the transition from Directives 90/385/EEC, 93/42/EEC and 98/79/EC to Regulations (EU) 2017/745 and (EU) 2017/746, the prior notice mechanism should also apply to devices placed on the market in accordance with the transitional provisions laid down in Regulations (EU) 2017/745 and (EU) 2017/746.

(16) Regulations (EU) 2017/745 and (EU) 2017/746 should therefore be amended accordingly.

(17) Since the objectives of this Regulation, namely to address risks of shortages of in vitro diagnostic medical devices in the Union and to facilitate the timely roll-out of Eudamed, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union (‘TEU’). In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(18) This Regulation is being adopted in view of the exceptional circumstances arising from an imminent risk of shortages of in vitro diagnostic medical devices and the associated risk of a public health crisis, as well as the significant delay in the development of the electronic system on clinical investigations and performance studies of Eudamed. In order to attain the intended effect of amending Regulations (EU) 2017/745 and (EU) 2017/746 and to ensure the availability of such devices the certificates of which have already expired or are due to expire before 26 May 2025, to provide legal certainty for economic operators and healthcare providers, and for reasons of consistency as regards the amendments to both Regulations, this Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union.

(19) To allow manufacturers and other economic operators time to adapt to the obligation to provide notice of an anticipated interruption or discontinuation of supply of certain devices, it is appropriate to defer the application of the provisions related to such an obligation,