In order to ensure a continuous supply of in vitro diagnostic medical devices, the European Commission proposes to extend the periods initially foreseen in the Regulation concerning the transitional provisions.
Please note that this proposal does not aim to change the date of application of the Regulation. For all new devices and for class A devices, the Regulation will therefore apply from 26 May 2022.
However, for devices already placed on the market under the Directive, the EC is proposing various measures:
1) To extend the period of validity of certificates of conformity to the Directive 98/79/EC and thus extend the period of placing on the market and putting into service of devices covered by such a certificate
This measure concerns devices covered by Annex II of the Directive and self-diagnostics for which the conformity assessment therefore involved a notified body.
As a reminder, it was initially foreseen that certificates of conformity to the Directive would no longer be valid after 26 May 2024. If the proposal is accepted, certificates of conformity could remain valid for a further year, i.e. until 26 May 2025 at the latest. Notified Bodies that have limited the validity of certificates of conformity will then have to re-issue certificates with a new validity date and define the conditions for this re-issuance.
Devices with a valid certificate of conformity could therefore continue to be placed on the market and put into service until their expiry date, and at most until 26 May 2025.
2) Extend the period of placing on the market and putting into service of devices covered by a declaration of conformity to the Directive
This measure concerns devices that do not require the intervention of a notified body under the Directive. These devices, if covered by a declaration of conformity with the Directive drawn up before 26 May 2022, could continue to be placed on the market or put into service, depending on the class they take under the Regulation, i.e:
- until 26 May 2025 for Class D devices
- until 26 May 2026 for Class C devices
- until 26 May 2027 for Class B devices
- until 26 May 2027 for Class A sterile devices
3) Extend the period of availability on the market of devices covered by a certificate of conformity with the Directive or a declaration of conformity with the Directive.
If they have a certificate or a declaration of conformity with the Directive, devices placed on the market from 26 May 2022 onwards could continue to be made available on the market:
- Until 26 May 2026 for Class D devices
- Until 26 May 2027 for Class C devices
- Until 26 May 2028 for Class B devices and Class A sterile devices
This extension would only apply to devices placed on the market from 26 May 2022. For those placed on the market BEFORE 26 May 2022, no change is foreseen, they can continue to be made available on the market until 26 May 2025.
Let’s now wait for the opinion of the European Parliament and the Council for the adoption of this proposal… which could prove to be excellent news for manufacturers even if it promises a complex stock management system!
https://ec.europa.eu/commission/presscorner/detail/fr/IP_21_5209
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