January 22, 2024

Are DoC Updates Required for Software Version Changes?

In general, yes.  I explain:

Remember that the MDR requires the manufacturer to “continuously update the EU declaration of conformity”.  For example, if the Technical Documentation (TD) is different for version 3.0 compared to 3.1 to 3.1.1 to 3.2, then the DoC needs to be updated accordingly along the way. Indeed, as soon as the TD is updated, the prior corresponding DoC is no longer valid.  The Blue Guide states that the DoC is specific to each individual product, even if they are manufactured in series. The Blue Guide also states that, in practice, the same version of the DoC may be applicable to many individual products (or versions) which are manufactured in series. However, as soon as any of the elements of the EU declaration of conformity changes, the version of the DoC will have to be updated.

But we do have some flexibility with the format of the DoC. Ultimately, multiple different devices or versions may be encompassed by a single DoC.  This is based on traditional precedent from the Blue Guide, EN ISO/IEC 17050-1, etc.  As long as all the required fundamental DoC contents/elements (e.g., per Annex IV of 2017/745) are clearly distinguished for each subject device or version, then multiple devices or device versions can be present on the DoC.