We are often asked about the purpose of the Declaration of Conformity (DOC) in the context of CE Marking of devices. Let's first start by defining what the DOC is, why it is needed and what it should include.
The DOC is a one-page document on which you, as the manufacturer of a medical device, "declare" your "conformity" with the Essential Requirements of the European Medical Device Directive (93/42/EEC). Annex 7 of the Directive spells out the need for an EC Declaration of Conformity.
All manufacturers of medical devices-whether you self-declare or require Notified Body intervention-must prepare a DOC, a legally binding document that should be signed by a senior company officer. Think of it as a sworn statement in which you declare in public that you have met all of the regulatory obligations required to market your products in Europe.
The CE Marking Certificate
If you manufacture a Class I (Sterile or Measuring), IIa, IIb or III device, you will need to be audited by a Notified Body to obtain what is commonly called a "CE Certificate." This registration audit is part of the Conformity Assessment process. The CE certificate is issued by your chosen Notified Body (examples: TUV, BSI, Intertek, SGS, UL, etc.) after successful completion of your registration audit. Once all compliance requirements have been met and the CE certificate has been issued, you can then prepare a DOC.
Often, people confuse the CE certificate with the DOC. Each CE certificate comes with a certificate number that you may choose to place on the DOC. Also, you will need to list the name of your Notified Body (if applicable) and its corresponding four-digit identification number.
Some Notified Bodies have been requiring companies to have a completed and signed DOC as part of their Technical File during the review process, which in most cases happens before or during the on-site registration audit. Since the DOC is a legally binding document, it should only be signed once you have met all the Essential Requirements of the Directive, which includes a successful on-site inspection by a Notified Body. If this becomes an issue for your company, provide your Notified Body with a signed copy but clearly identify it with a stamp that says "SAMPLE."
The DOC must be printed on your company letterhead and should include the following pieces of information:
- Device trade name and model number
- Device classification (Class and Rule)
- Your company name and address
- Name of quality management representative
- Notified Body name and ID number (if applicable)
- CE certificate number (if applicable)
- Date CE Marking was first applied
- Authorized Representative contact information
- Route to compliance (example: Annex 2, 5, 7)
- Standards applied (optional)
- Name and signature of company officer
This list may vary depending on your Notified Body (if applicable), and the document's format is not dictated by the regulatory authorities. The content is the most important, as the information is declaring to the reviewer that your products are fully compliant with the Essential Requirements for Medical Devices.
With regard to listing applied standards on the DOC, opinions vary. Some say that inclusion of the standards is required; others say it is not.
Medical device harmonized standards, which have been developed specifically to deal with the Essential Requirements of the Medical Device Directive, provide the presumption of conformity. In their absence, the manufacturer is entitled to comply by using any appropriate specifications that may demonstrate conformity with the Essential Requirements. However, the manufacturer must bear the burden of proof that the use of specifications other than the medical device harmonized standards brings the device into conformance.
The inclusion of standards in the DOC does provide additional useful information to the distributor, Authorized Representative and Inspection Authorities. However, it also may raise questions as to why some standards were listed while others that may apply were not. Furthermore, it requires more frequent updates of your DOC as standards change over time.
Considering some of these disadvantages, many companies opt not to include standards and provide such a listing only upon request by distributors and/or inspection authorities. Notified Bodies, however, may have a different opinion on listing applied standards.
The DOC must be written in one of the official languages of the European Union. Luckily, English is one of them. That being said, we recommend that you have your DOC translated, if possible. Given the small amount of text on a DOC, the cost of doing so would be minimal and it could head off potential confusion among a Competent Authority or Customs official whose English skills might be lacking. Again, this is not required but recommended.