C 152/86
EN
Official Journal of the European Union
6.4.2022
1.7.
The EESC notes that postponing the date of application by one year would not solve the problems regarding implementation of Regulation (EU) 2017/746 and that a gradual introduction of the requirements of the new regulation over a longer period of time should be allowed, while giving priority to high-risk in vitro diagnostic medical devices.
This can be achieved by amending Article 110 of the Regulation, which concerns transitional provisions, providing a period for existing higher risk class devices that is shorter than the one for existing lower risk class devices.
At the same time, the existing transitional period for devices covered by notified body certificates issued under Directive 98/79/EC should be extended by one year, until 26 May 2025.
1.8.
The EESC therefore supports the Commission’s proposals to:
— extend the transitional period for devices covered by a certificate issued under Directive 98/79/EC; — introduce tailor-made transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time; — introduce a transitional period for requirements applicable to devices manufactured and used within the same healthcare facility.
2.
The Commission proposal 2.1.
Directive 98/79/EC (4) on in vitro diagnostic medical devices will be replaced as of 26 May 2022 by Regulation (EU) 2017/746 (5) establishing a new regulatory framework for these devices (HIV tests, pregnancy tests or SARS-CoV-2 tests) (6). 2.2.
The new regulation aims to ensure the smooth functioning of the internal market and a high level of protection of public health, patients and users, taking into account the high number of SMEs active in this sector. 2.3.
One of the main changes concerns the involvement of independent conformity assessment bodies.
With the new Regulation, around 80 % of in vitro diagnostic medical devices will be under the control of notified bodies (compared to 8 % at present).
This means that manufacturers will have to apply to a notified body and obtain one or more certificates following a procedure that takes approximately one year. 2.4.
Article 110 of Regulation (EU) 2017/746 contains transitional provisions for devices with a certificate issued by a notified body in accordance with Directive 98/79/EC prior to 26 May 2022. 2.5.
The COVID-19 pandemic has confirmed the need for a regulatory framework for in vitro diagnostic medical devices in the EU but has also given rise to additional, unprecedented challenges for the implementation of Regulation (EU) 2017/746. 2.6.
Thus, substantial additional resources have been necessary from Member States’ competent authorities, health institutions, notified bodies, manufacturers and other economic operators to increase the availability of vitally important medical diagnostics. 2.7.
The fact that the six currently designated notified bodies are located in only three countries (Germany, France and the Netherlands) also makes the situation particularly difficult for SMEs in other Member States.
In addition, travel restrictions have hampered, and continue to hamper the proper conduct of conformity assessment by notified bodies.
2.8.
This proposal therefore aims to:
— extend the existing transitional period for devices covered by a certificate issued under Directive 98/79/EC; — introduce tailor-made transitional periods for devices that are to undergo a conformity assessment involving notified bodies for the first time, in accordance with Regulation (EU) 2017/746;
(4) (5) (6)
OJ L 331, 7.12.1998, p. 1.
EESC opinion (OJ C 18, 22.1.1996, p. 12).
OJ L 117, 5.05 2017, p. 176.
EESC opinion (OJ C 133, 9.5.2013, p. 52).
According to the Commission, around 70 % of clinical decisions are made using in vitro diagnostic medical devices.