Amendment to EP and Council Regulation 2017/746, IVDR

On 28 January 2022, Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746concerning transitional provisions for certain in vitro diagnostic medical devices and the deferral of the conditions of applicability for devices manufactured and used within medical establishments.

The change concerns:

• Article 110 Transitional provisions
• Article 112 Cancel
• Article 113 Entry into force and applicability

Details can be found under the following link:

Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferral of conditions of application for devices manufactured and used within medical devices