31.10.2022
To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders
Please be informed that on 04.07.2022, the European Commission published the Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council.
In case of some class D in vitro diagnostic medical devices D falling under the scope of Regulation (EU) 2017/746, there are no harmonised standards as regards some requirements of Annex I to the respective Regulation and it was necessary to address public health concerns, since the risk associated with the use of the respective medical devices is vital for public health and patient safety. Thus, common specifications have been adopted for the concerned devices, as regards the respective requests.
This Regulation is available online:
https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=CELEX:32022R1107&from=EN.