By Bob Mehta
The EC Declaration of Conformity (DoC) is much more than a piece of paper being signed by the head of quality or regulatory affairs. It is a symbolic document that reflects a device manufacturer’s commitment to quality and its overall compliance with 93/42/EEC, the European medical device directive. According to Annex II of the directive, “The EC Declaration of Conformity is the procedure whereby the manufacturer who fulfills the obligations imposed by Section 1 ensures and declares that the products concerned meet the provisions of this directive, which apply to them.”
The DoC is the subject of annexes V, VI, and VII. In each of them, the same basic concept applies, with the manufacturer stating compliance to each of the requirements in it.
So what relevant information does the DoC contain? It must have:
- Basic information pertaining to the device manufacturer, such as name, address, and date the DoC was scripted;
- The device(s) approved during the application process, including their name(s) and part number(s);
- The name and address of the notified body, including its registration number; for example, TUV-R 0197;
- The date(s) and lot number(s) of the first device(s) shipped; and
- The signature of the device manufacturer’s head of quality or regulatory affairs.
Once the DoC has been scripted and signed, the device manufacturer should retain a copy while another is sent to the notified body. I always recommend placing a copy into the technical file or design dossier, although it’s not required. Once the device application is approved, the regulatory review is completed, and the DoC is created, only then can the device manufacturer affix the CE marking of conformity to its products.
One of the requirements listed in each of the annexes referring to the DoC, with the exception of Annex VII, is the need for device manufacturers to create and maintain effective quality management systems (QMS). Although there is no mention of ISO 13485 in the MDD, the expectation of the notified bodies is that the QMS implemented by device manufacturers meet ISO 13485 requirements. One of the basic changes made to EN ISO 13485:2012 is the addition of annexes ZA, ZB, and ZC, which point to the three European medical device directives: 90/395/EEC, or the Active Implantable Medical Device Directive; 98/79/EC, or the In Vitro Diagnostic Device Directive; and 93/42/EEC, or the MDD.
One final point to take away is the need for notified bodies to physically assess a device manufacturer’s QMS. It is a fundamental requirement for them to assess it prior to issuing device approvals. If it is up to standards, the notified body will issue a certificate saying that the QMS is in compliance with ISO 13485.
Bob Mehta is the Principal Consultant & Recruiter at GMP ISO Expert Services (www.gmpisoexpert.com) and provides consulting service in Pharma, Biotech, Medical Device, API, and Food/Dietary Supplement industries. Bob has over 23 years of experience, including as a principal consultant, in the quality systems, training and regulatory compliance areas. He has written educational articles in the areas of quality and compliance for Medical Device & Manufacturing (MD&M), Quality Progress, and Nutraceutical World.