The In Vitro Diagnostic Devices Regulation 2017/746 (“IVDR”) became fully applicable on 26 May 2022. Together with the Medical Devices Regulation 2017/745 ("MDR"), which became applicable last year on 26 May 2021, IVDR is set to overhaul the regulatory regime for medical devices and reinforce the regulatory framework for medical tests which has been in place for over 20 years under Directive 98/79/EC ("IVDD") and Directives 93/43/EEC and 90/385/EEC ("MDD").
As highlighted in our previous update in January 2022, the European Parliament and the Council amended the transitional provisions of the IVDR for those devices already on the market. While the amendment allowed for a progressive roll-out of the IVDR (with the length of the transition periods depending on the risk class of the device), IVDR applies fully across all EU Member States from 26 May 2022.
In Ireland, two new regulations were enacted on the same day to strengthen the enforcement of IVDR. The In Vitro Diagnostic Regulations 2022 (S.I. 256 of 2022) (the "IVDR Regulations") and European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022 (S.I. 257 of 2022) (the "National IVDR Office Regulations") establish a range of offences for failure to implement IVDR and expand the role of the Irish national regulator, the HPRA. Irish businesses in particular should be aware of these Regulations which raise the stakes in ensuring compliance with the IVDR.
The Regulations enhance regulatory oversight and enforcement through expansion of the HPRA's remit, establishing a national body tasked with upholding ethical standards in the conduct of performance studies required under the IVDR, called the National Office for National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices (the "National IVDR Office") and formalising the rules around the conduct of ‘Performance Studies’.
The IVDR Regulations give the HPRA a new role in enforcement of IVDR. At the extreme end of the scale, the HPRA's "authorised officers" may now conduct 'dawn raids' or unannounced inspections, accompanied by the Gardaí, in circumstances where the HPRA has grounds to suspect non-compliance with the IVDR. At the lower end of the scale, the HPRA may issue notices and orders requiring corrective action be taken to comply with the IVDR.
The IVDR Regulations establish a number of Irish criminal law offences for non-compliance with IVDR. Businesses, in their role as manufacturers, authorised representatives, importers, distributors and organisers of performance studies, can be prosecuted for the relevant offences on a summary basis or on indictment, and face sanctions of up to €300,000 and / or 10 years imprisonment. As one would expect, the offences include non-compliance with IVDR requirements involving compliance with safety and quality requirements before placing IVDs on the market, including during performance studies, and compliance with post-market surveillance requirements.
Overall, all involved in the supply of IVDs should raise awareness within their businesses of the enhanced powers of enforcement and severe new Irish criminal sanctions and ensure full compliance with all provisions of the IVDR at the end of the transitional periods.