At present, there is no need to request a current declaration of conformity, if there are no changes, in addition to the original declaration of conformity issued before the date of application of the MDR (26 May 2021) or IVDR (26 May 2022), with reference to Art. 120 MDR or Article 110 IVDR.

However, in the event of non-significant changes that require an amendment to the declaration of conformity (e.g. change of name, change of address), the existing declaration of conformity is supplemented by an addendum or annex in accordance with the directive.

This has now been clarified by the German market surveillance authorities (AGMP) and it is particularly pointed out that there may NOT be a new declaration of conformity according to MDD/ IVDD, but only a “supplement” (see above) to the declaration of conformity issued before 2021-05-26 (MDD)/ 2022-05-26 (IVDD), which clearly states the non-significant changes (e.g. also new product variants).