MDCG: Guidance on transitional provision of IVDR
On 26 May 2022, the European IVD Regulation (EU) 2017/746 (In vitro Device Regulation) will enter into force. This will be accompanied by various transitional periods and requirements, which have been summarised and explained by the MDCG (Medical Device Coordination Group) in a new guidance document. The 17-page Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR is aimed at manufacturers who have so far complied with the requirements of Directive 98/79/EC and may continue to market their in vitro diagnostic devices in accordance with this Directive during the transitional periods.
The medical devices discussed therein must hold
- a valid certificate issued by a notified body in accordance with Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), and
- a declaration of conformity issued prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure under the IVDR (contrary to the IVDD) requires the involvement of a notified body.
A further requirement is that during the transition period no significant changes to the design or intended purpose have been made to devices placed on the market under the old Directive.
With practical tools such as flowcharts for self-assessment and clarification of questions on product changes, the guideline offers a clear compilation on this topic and shows in detail which changes are to be assessed as significant and which are not. Changes classified as significant result in the transitional provisions no longer being applicable to a product.
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