Senior Regulatory Affairs Consultant at ConvaTec
2 min reading time
3) Ensure the DoC includes all directives applicable to the product. Even though devices are governed by their ‘primary’ directive, a number of devices require compliance to other directives before the CE mark can be affixed, e.g. many electrical and electronic devices fall under the RoHS 2 Directive (2011/65/EU). This is a ‘CE marking’ directive which requires compliance to before the CE mark can be affixed (even if the device has the CE mark to its relevant medical device directive granted). The RoHS 2 Directive requires a specific DoC is drafted and signed which declares compliance of the device to the directive. Ensure all DoCs are drafted and signed which are applicable to a device. These individual DoCs can be collated together as a single DoC covering the device, or as single DoCs.
4) The DoC is used by regulatory bodies for identifying the products placed on the market by individual companies. Traceability of the products is therefore vital and so the DoC should contain unambiguous data to support full identification of the products placed.
5) Ensure all technical standards are listed within the DoC, and ensure the references to the standards are full and identical to the standard name – do not abbreviate or shorten their name.
To ensure consistency in DoC content it is essential a company devises and maintains a procedure for DoC content and control. I draw up DoCs meeting the requirements of BS EN ISO/IEC 17050-1:2010 ‘Conformity assessment – Supplier’s declaration of conformity – Part 1: General requirements’. This details the minimum, and product specific details, required within a DoC. I also have started transitioning DoCs so they contain the information described within Annex III of the proposed regulations – there has been no debate on this section of the proposed regulations – so ensuring all DoCs are compliant ahead of time.
Even though these suggestions are ‘common sense’, it is worth reiterating the importance of the DoC; a single document whose relevance and legal importance is often lost within the mountain of other documents that are generated and signed.
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Alvin Tai Great advice, Marcus. Sometimes "common sense" gets lost in the chaotic nature of medical device manufacturing.
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