Regulation (EU) 2022/112

What it is

to propose a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 to prevent disruption in the supply of these essential healthcare products. PROPOSED ACT: Regulation of the European Parliament and the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Regulation (EU) 2017/746 on in vitro diagnostic medical devices establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. The new Regulation will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022 and introduce substantial changes in the sector. The European Parliament adopted by 687 votes to 6, with 4 abstentions, a legislative resolution 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. The European Parliament adopted its position at first reading under the ordinary legislative procedure by taking over the Commission's proposal. The objectives of this amending Regulation are to extend the transitional periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices, to introduce additional transitional provisions in that Regulation and to defer the application of the provisions of that Regulation with regard to devices manufactured and used internally. In vitro diagnostic medical devices are essential for the health and safety of EU citizens and SARS-CoV-2 tests are particularly important for the fight against the COVID-19 pandemic. Given the unprecedented scale of the current challenges, it is very likely that Member States, healthcare institutions, notified bodies, economic operators and other stakeholders will not be in a position to ensure the proper implementation and full application of that Regulation from 26 May 2022. In order to ensure legal certainty and to avoid any disruption in the supply of these essential health products, this Regulation extends the existing transitional period for devices covered by certificates issued under Directive 98/79/EC and introduces tailor-made transitional periods for devices that are to be subject to conformity assessment involving notified bodies for the first time in accordance with Regulation (EU) 2017/746. - for low-risk devices such as Class B devices and Class A sterile marketed devices, 26 May 2027. The amending regulation also introduces a transitional period for the requirements applicable to devices manufactured and used within the same health institutions (in-house devices).

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