July 22, 2021

EU MDR Changes to MDD DoC under EU MDR Article 120

When considering the requirements for revising an MDD (or EU MDR) Declaration of Conformity (DoC) associated with device changes (whether significant or nonsignificant), it’s important to know that there must always be a valid DoC that accurately represents required details about the subject device’s current state of conformity.  Indeed, under the MDD (by way of the EN ISO/IEC 17050 series) and the EU MDR alike, manufacturers are required to continuously update the DoC to assure it remains accurate.

Accordingly, if any change is made to an MDD-certified device to be placed on the market after 26 May 2021 [the EU MDR Date of Application (DoA)] under EU MDR Article 120’s transitional provisions, then the subject device’s Declaration of Conformity (DoC) must be revised as needed if the nature of the change impacts the accuracy of the original declaration.

As we all know, the MDD and EU MDR both generally require that the Notified Body (NB) be informed about significant changes as part of updating the DoC and technical documentation.  But if the change truly is nonsignificant, then the MDD and EU MDR permit the DoC and technical documentation to be updated without notification to the Notified Body (NB).  That said, be sure to carefully review the NB contract, as some NBs may nonetheless demand to be somehow informed even for nonsignificant changes.

Examples of changes that would directly affect the accuracy (and thus require revision) of the DoC include but are not limited to address changes, standard edition changes, part numbers obsoleted, part numbers changed, and others.  Some of these might turn out to be either significant or nonsignificant depending on the associated particulars.  So “be sure you’re sure” about whether the change is significant or nonsignificant.

Regarding the clerical aspect (e.g., the form or format) of the revised DoC, it’s noteworthy that the EN ISO/IEC 17050 series has traditionally and normatively given manufacturers the liberty to decide what format suits them best even though it informatively offers an example format.  The EU MDR has not withdrawn such liberty.  Accordingly, to assure DoC accuracy, it seems that manufacturers could either append an amendment (e.g., via memo) pursuant to EN ISO/IEC 17050-1 clause 6.2 or EU MDR Annex IV.9, or else create a new DoC altogether.  I prefer the latter, as the memo-approach seems clunky and ripe for errors and omissions.  Either way, be sure that the expiry date of the DoC remains in alignment with Article 120’s cut-off dates if such changes are made for the context of EU MDR Article 120 transitional provisions.