In vitro diagnostic medical devices, Regulation (EU) 2022/112w3badmin
The Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 in relation to the transitional provisions for certain medical-diagnostic devices has been published in the Official Journal of the European Union. vitro and the deferred application of conditions concerning in-house manufactured devices.
With this document we are moving towards a progressive introduction of the Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices.
Regulation (EU) 2022/112 does not modify the requirements of Regulation (EU) 2017/746 in substance, but modifies its transitional provisions (Article 110).
No change is envisaged for CE marked devices that do not require the intervention of a notified body or for “new” devices, that is, those that have neither a certificate from a notified body nor a declaration of conformity pursuant to current directive 98/79 / EC.
For these types of devices, Regulation (EU) 2017/746 will apply from May 26, 2022, as envisaged.
Furthermore, a deferred application of the requirements for devices manufactured and used within the same healthcare institution (“in-house devices”) is envisaged. Regulation (EU) 2017/746 introduced a set of common rules for such devices, which include requirements for the justification of their use and rules to ensure their safety and performance, such as an adequate quality management system.
To learn more, see the page: European regulations on medical devices