UPDATE OF 25 JANUARY 2022
OFFICIAL! PUBLISHED IN THE OFFICIAL JOURNAL OF THE EUROPEAN UNION REGULATION (EU) 2022/112 AMENDING REGULATION IVDR (EU) 2017/746 ON TRANSITIONAL PROVISIONS FOR CERTAIN IVD DEVICES.
With the publication of Regulation (EU) 2022/112, the European Parliament modified the transition periods initially provided by Article 110 of IVDR.
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, Official Journal of the European Union, 28 January 2022
On 15th December 2021, the Council of the European Union, and the European Parliament adopted the proposal of the progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation, establishing new transitional periods according to the risk classes of the devices.
The amendment gives more time to many Operators in the IVD industry but does not edit the date set for the start of full application of the Regulation, which remains 26th May 2022 starting from non-sterile class A IVD devices.
IVD Operators satisfied
The need to postpone the full operation of the Regulation had been conceivable for some time and the contentment of interested parties was very high, thus preventing the risk that a large number of companies producing in vitro diagnostic devices might leave the market.
Stella Kyriakides, European Commissioner for Health and Food Safety, manifested joy as well: “In the midst of an unprecedented public health crisis, we cannot risk shortages of essential Medical Devices. Health systems and routine health services have been tested like never before. The pandemic has at the same time highlighted the vital need for accurate diagnostics and a resilient regulatory framework for in vitro Medical Devices. The amendment of the In Vitro Diagnostic Medical Devices Regulation will ensure that crucial Medical Devices, such as COVID or HIV tests, continue to be available and safe. Member States, Manufacturers and Notified Bodies must now use the additional time to build up the necessary capacities, and Manufacturers must prepare to transition to the new requirements. There is no time to rest.”
At this point, it is pivotal to solve one of the main problems of the sector, namely the shortage of Notified Bodies (NBs) designated in accordance with IVDR Regulation (EU) 2017/746. The number of NBs should be implemented to enable companies to make available on the market IVDR devices in accordance with the Regulation.
What are the transition periods according to the risk class of IVD devices?
- For higher risk devices (class D) requirements apply from 26th May 2025;
- For class C devices, the implementation date is 26th May 2026;
- For class B devices and class A devices placed on the market in sterile condition, requirements apply from 26th May 2027.
IVDR Regulation applies starting from 26th May 2022 for those CE marked IVD devices that do not require the involvement of a Notified Body (that is to say non-sterile Class A devices) and for “new” In-Vitro Diagnostic Medical Devices (namely those that do not have a certificate, or a declaration of conformity issued in accordance with the Directive 98/79/CE).
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European Parliament legislative resolution of 15 December 2021 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic Medical Devices and deferred application of requirements for in-house devices