746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices - Main contents

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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
date	March 15, 2023

(1) Regulations (EU) 2017/745 ¹⁹ and (EU) 2017/746 ²⁰ 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 in Council Directives 90/385/EEC ²¹ and 93/42/EEC ²² and Directive 98/79/EC of the European Parliament and of the Council ²³ , such as the supervision of notified bodies, conformity assessment procedures, clinical evidence requirements, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding 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 has been postponed by one year to 26 May 2021 by Regulation (EU) 2020/561 of the European Parliament and of the Council ²⁴ , while the date of 26 May 2024 was maintained as end of the transition period by which certain devices that continue to comply with Directive 90/385/EEC or Directive 93/42/EEC may be placed on the market or put into service.

(3) Also due to the impact of the COVID-19 pandemic, the transition period provided for in Regulation (EU) 2017/746 has already been extended by Regulation (EU) 2022/112 of the European Parliament and of the Council ²⁵ .

(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 under 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, taking into account also the complexity of those new requirements. Therefore, it is very likely that many devices that may be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017/745 are not going to be certified in accordance with that Regulation before the end of the transition 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 under Directives 90/385/EEC and 93/42/EEC and to extend the transition period during which devices that are in conformity with those Directives can be placed on the market. The extension should be sufficiently long to give notified bodies the time needed to carry out the conformity assessments required of them. The extension aims at ensuring a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of health services, without lowering current quality and 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 steps to transition towards compliance with Regulation (EU) 2017/745 will benefit from the additional time.

(7) To ensure progressive transition to Regulation (EU) 2017/745, the appropriate surveillance regarding devices benefiting from the transition period should eventually pass over from the body that has 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 it should be provided that the notified body should not be responsible for conformity assessment and surveillance activities carried out by the outgoing body.

(8) As regards the period of time needed to allow manufacturers and notified bodies to carry out the conformity assessment in accordance with Regulation (EU) 2017/745 of medical devices that had been CE marked 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 transition 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. Having regard to insufficient notified body capacity and the fact that manufacturers of custom-made devices are often small or medium-sized enterprises that did not have access to a notified body under Directives 90/385/EEC and 93/42/EEC, a transition period should be provided during which class III custom-made implantable devices may 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 of devices which are placed on the market by the end of the applicable transition period and which are still in the supply chain one year after the end of that transition period. To prevent 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 devices, such further making available of devices should be unlimited in time.

(11) The adoption of this Regulation takes place due to 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 the amendments to 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, it is necessary for this Regulation to enter into force as soon as possible. For the same reasons it is also considered appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.