Senior Regulatory Affairs Consultant at ConvaTec
2 min reading time
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?!
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Gottfried Griesmayr There is no "one size fits all" DoC for medical devices, because its content will depend on the product! The applicable directives (may be more than one!), the classification of the device including reference to the applied rules, the conformity assessment procedure (e.g. Annex II) and the applied harmonized standards are mandatory content. Insufficient DoC's do likely exist for class I devices. If a notified body is involved they verify the DoC.
The DoC is signed by an authorized representative of the manufacturer. He/she must have executive responsibility. One ore more signatures depends on the organizational structure. The CEO is sufficient in any case.
An important point often ignored is the expiry date! A DoC cannot be signed forever because regulations are changing. Include a statement: "This Declaration of Conformity expires five years after date of issue". After that period verify regulatory status and sign a new declaration.
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Good timing! I am in the process of looking through our TF/DDs and I will pay closer attention to the DOCs due to this post. Thanks!
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Auke Poutsma Dear all, the first case described by Marcus indicates that the company is not aware of the regulatory requirements. The DoC is critical and confirms compliance with the regulatory requirements applicable (could be more than one Directive). Who signs is well described by Gottfried, some one who understdnads the regulations and has executive responsibility in the company!
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