The Declaration of Conformity (DoC) is arguably the most important document, from a regulatory perspective, that a medical device company shall draft and sign. It is the sole document that declares the product(s) listed conform to the regulations governing their placing on the market. The legal importance and relevance of the DoC cannot be underestimated, however there seems to be a great deal of inconsistency in DoC content which can lead to a host of issues – such as customs stopping shipments of devices from entering certain Middle Eastern countries because the DoC does not contain certain information even though the devices have the CE mark legally affixed (these incidents do bode the question however on the competency of the importer who review the DoC beforehand and fail to notice such error – but that’s a different discussion!)

The DoC is always requested by the notified body for review, either within the initial CE mark submission, or a scheduled recertification audit, or as part of an unannounced audit, and it is one document which often has minor (and major) non-conformities attached to it. Interestingly, in spite of its importance, the DoC content is not described within the medical device directive. It is however described (Annex III) within the proposed regulations and I assume this is because of the inconsistencies observed.

However, to ensure the DoC is applied correctly, can I offer a number of suggestions to ensure compliance? Many of these are ‘common sense’ but are suggestions based on observations that I have seen and heard about talking to colleagues in the device industry;

1) Ensure you have a DoC and understand its importance and relevance. I have heard of device companies who affix the CE mark and ‘distance sell’ their products over the internet not realising they require a DoC. It doesn’t matter whether you ‘distance sell’ or sell in the ‘traditional’ face-to-face manner, or a combination of the both, manufacturers who apply the CE mark to their product must draft and sign a DoC.

2) This leads me to the second observation – signatories. Who signs the DoC, and how many signatures are required? I believe this should be decided upon by individual companies – I have seen DoCs with one signature, conversely I have seen DoCs with four signatures. There isn’t a set rule on the number of people who sign the DoC, however it is important that the persons signing the DoC understand and appreciate its content, relevance and legal importance. They must have an understanding of the products conformity assessment to be qualified to sign the DoC. After all, would you sign a legal document you don’t understand?!

source: https://www.linkedin.com/groups/78665/78665-6052866037160960000