|Author (Corporate)||Council of the European Union, European Parliament|
|Series Title||Official Journal of the European Union|
|Series Details||L 19, Pages 3-6|
|Content Type||Legislation, Policy-making|
Regulation (EU) 2022/112 - formally signed by the co-legislators on 25 January 2022 - introducing amendments to Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices. This is a text with EEA relevance.
Regulation (EU) 2017/746 - also known as the In Vitro Diagnostic Medical Devices Regulation - updated rules on placing on the EU market, making available and putting into service in vitro diagnostic (IVD) medical devices for human use and their accessories. It also contains rules on the conduct of performance studies carried out in the European Union concerning IVD medical devices (or accessories).
This draft law proposed a progressive roll-out of the Regulation to prevent disruption in the supply of these healthcare products. The challenges posed by the COVID-19 (coronavirus) pandemic diverted resources from Member States, health institutions and economic operators towards addressing the crisis, thereby hampering the capacity to comply on time with the changes introduced. It did not change requirements in substance but changed the transitional provisions to allow the Regulation's progressive rollout.
The proposal was tabled by the European Commission on 14 October 2021. The draft Regulation was adopted by the European Parliament on 15 December, followed by the Council of the European Union on 20 December. The Act was signed by the co-legislators on 25 January 2022, and published in the Official Journal on 28 January 2022. The rules became applicable on 26 May 2022.
|Subject Categories||Health, Internal Markets|
|Subject Tags||Consumer Rights | Protection, Medicines | Medical Devices, Public Health|
|International Organisations||European Union [EU]|