Considerations on COM(2023)10 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

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dossier COM(2023)10 - Amendment of Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices ...
document COM(2023)10 EN
date March 15, 2023
 
table>(1)Regulations (EU) 2017/745 (3) and (EU) 2017/746 (4) of the European Parliament and of the Council establish a new 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 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 introduce provisions ensuring transparency and traceability in respect of medical devices and in vitro diagnostic medical devices.
(2)Due to the impact of the COVID-19 pandemic, the date of application of Regulation (EU) 2017/745 was postponed by one year to 26 May 2021 by Regulation (EU) 2020/561 of the European Parliament and of the Council (8), while 26 May 2024 was maintained as the end date of the transitional period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC can lawfully be placed on the market or put into service.

(3)Also due to the impact of the COVID-19 pandemic, the transitional period provided for in Regulation (EU) 2017/746 was already extended by Regulation (EU) 2022/112 of the European Parliament and of the Council (9).

(4)Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2024. It appears that a large number of manufacturers, especially small and medium-sized enterprises, are not sufficiently prepared to demonstrate compliance with the requirements of Regulation (EU) 2017/745, in particular when the complexity of those new requirements is taken into account. Therefore, it is very likely that many devices that can lawfully be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017/745 will not be certified in accordance with that Regulation before the end of the transitional period, which leads to the risk of shortages of medical devices in the Union.

(5)In light of reports from healthcare professionals about the imminent risk of shortages of devices, it is necessary, as a matter of urgency, to extend the validity of certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC and to extend the transitional period during which devices that are in conformity with those Directives can lawfully be placed on the market. The extension should be of sufficient duration to give notified bodies the time needed to carry out the conformity assessments required of them. The extension aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements.

(6)The extension should be subject to certain conditions to ensure that only devices that are safe and for which the manufacturers have taken certain steps to transition towards compliance with Regulation (EU) 2017/745 will benefit from the additional time.

(7)To ensure a progressive transition to Regulation (EU) 2017/745, the appropriate surveillance regarding devices benefiting from the transitional period should eventually be transferred from the notified body that issued the certificate in accordance with Directive 90/385/EEC or Directive 93/42/EEC to a notified body designated under Regulation (EU) 2017/745. For reasons of legal certainty, the notified body designated under Regulation (EU) 2017/745 should not be responsible for conformity assessment and surveillance activities carried out by the notified body that issued the certificate.

(8)As regards the period needed to allow manufacturers and notified bodies to carry out the conformity assessment in accordance with Regulation (EU) 2017/745 of medical devices that are covered by a certificate or a declaration of conformity that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC, 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 medical devices concerned, so that the period is shorter for devices belonging to a higher risk class and longer for devices belonging to a lower risk class.

(9)Contrary to Directives 90/385/EEC and 93/42/EEC, Regulation (EU) 2017/745 requires the involvement of a notified body in the conformity assessment of class III custom-made implantable devices. Due to insufficient notified body capacity and the fact that manufacturers of custom-made devices are often small or medium-sized enterprises which lack access to a notified body under Directives 90/385/EEC and 93/42/EEC, a transitional period should be provided for, during which class III custom-made implantable devices can lawfully be placed on the market or put into service without a certificate issued by a notified body.

(10)Article 120(4) of Regulation (EU) 2017/745 and Article 110(4) of Regulation (EU) 2017/746 prohibit the further making available on the market or putting into service of devices which are placed on the market by the end of the applicable transitional period and which are still in the supply chain one year after the end of that transitional period. To prevent the unnecessary disposal of safe medical devices and in vitro diagnostic medical devices that are still in the supply chain, thus adding to the imminent risk of shortages of such devices, such further making available on the market or putting into service of such devices should be unlimited in time.

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

(12)Since the objectives of this Regulation, namely to address risks of shortages of medical devices and in vitro diagnostic medical devices in the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of their 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.

(13)This Regulation is being adopted in view of the exceptional circumstances arising from an imminent risk of shortages of medical devices and the associated risk of a public health crisis. In order to attain the intended effect of amending Regulations (EU) 2017/745 and (EU) 2017/746 and to ensure availability of devices whose certificates have already expired or are due to expire before 26 May 2024, 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. For the same reasons, it is also considered to be appropriate to invoke the exception to the eight-week period provided for in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the TEU, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community,