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.
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:
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.
Many other questions often arise on this subject. Following are some answers to the more common queries.
Does the DOC need to ride along with shipments? Technically, you are not required to send your DOC with your shipments. However, it is recommend that you include it with your shipping documents, when practical, as it is one more way you can demonstrate to Customs officials and Competent Authorities that your products are in full compliance with the Directive.
Should the DOC be updated every year? It is recommended (but not required) that you update your DOC once per year and provide an up-to-date copy to your distributors and Authorized Representative.
Who should sign the DOC? Ideally, the DOC should be signed by an officer of the company. Remember, the DOC is a legally binding statement and, by signing it, that representative is taking legal responsibility for the company's products placed on the European marketplace.
What date should we place on the DOC? Put a date on the DOC that is after you have received a CE certificate from your Notified Body. If you self-declare, just put a date on it that post-dates your compliance with all of the requirements of the Directive.
How long must we maintain the DOC with our Technical File? You are currently required to maintain a copy of your Technical File, including the DOC, for five years after the date the last product was manufactured. Upcoming changes to the MDD will likely require you to maintain it for the "useful life of the product" or five years, whichever is greater.
Does an Officer have to physically sign every DOC that rides along with shipments to Europe? No, a digital signature is fine. However, we recommend that the DOC is printed on original letterhead to maintain a sense of protection and authenticity.
Should anyone else have a copy of the DOC? Give a copy of your DOC to your distributor(s) and European Authorized Representative (AR). Sometimes problems arise with Customs or a Competent Authority, and they often call the AR or distributor first. It will help if the distributor or AR has this information on file. In summary, the DOC is an important, legally binding document, and you should take care in preparing it.
Originally published in May 2006, revised September 2010