21.02.2022
To the attention of manufacturers of in vitro diagnostic medical devices in Romania and all interested parties
REGULATION (EU) 2022/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
Please be informed that on 28 January 2022, the Official Journal of the European Union published Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.
Regulation (EU) 2022/112, leaving unchanged the IVDR application date of 26 May 2022:
– provides that devices legally placed on the market through a certificate issued by a notified body in accordance with the current Directive on in vitro diagnostic medical devices (Directive 98/79/EC; IVDD) before 26 May 2022 may continue to be placed on the market or commissioned by 26 May 2025.
– introduces adapted transition periods for devices which are to be subject to a compliance assessment involving bodies notified under the Regulation (IVDR) for the first time, but which have a Declaration of Compliance issued in line with Directive (IVDD) before 26 May 2022. The length of the transition period depends on the risk class of the device in question. Lower risk devices (class B and class A devices in sterile condition) may be placed on the market or commissioned until 26 May 2027, while higher risk devices (class D and class C devices) may only be placed on the market or commissioned until 26 May 2025 and 26 May 2026 respectively. During these extended transition periods, devices must continue to comply with Directive 98/79/EC and must not have significant changes in their design and intended purpose.
– provides an additional period to healthcare institutions manufacturing devices for use in their own premises (i.e. so-called in-house devices) in order to meet the conditions set out in Article 5 of Regulation (EU) 2017/746 (IVDR).
Regulation (EU) 2022/112 is available online: EUR-Lex – 32022R0112 – EN – EUR-Lex (europa.eu)