What is a Declaration of Conformity?

A Declaration of Conformity (DoC) is a required self-certifying document created by the medical device manufacturer to state that a device or a series of devices complies with the conformity requirements of a particular country’s regulations. If a DoC is required in a country, specifically in the European Union, the DoC confirms that a product is in compliance with all relevant European product safety requirements. DoC is required for each product and identifies the party responsible for market authorization activities in the applicable country.

Why is a Declaration of Conformity necessary?

Declarations of Conformity require the signee to take responsibility for a product’s compliance within that country’s rules and regulations. It also allows government authorities and regulatory bodies to identify who is legally responsible for a product and its regulatory activity, such as obtaining a CE mark.

Why are Standards often listed in the Declaration of Conformity?

Governments often use industry standards to define sections of the conformity assessment for particular devices. These standards are developed by standards organizations, such as ISO and IEC. For example, the ISO 13485:2016 standard defines quality management system (QMS) requirements for medical device organizations. Typically, highly developed countries use a particular version of a standard in their regulations. A manufacturer is then required to state that they are compliant to those standards when they submit their documentation – in the form of a DoC. Drafting a European Union DoC is an important part of the CE marking process and is the final step before affixing the CE mark to your product. 

Countries that Require a Declaration of Conformity

Declarations of Conformity are required in many countries, though some refer to a “Certificate” of Conformity. Countries that currently have a DoC requirement:

• Australia  
• Brazil – Still in development
• China
• European Union - All countries in the EU require a DoC, but you only need to create one document
• Malaysia
• Saudi Arabia  
• Singapore – Singapore will accept an EU DoC in most cases, but in certain circumstances will require a Singapore DoC
• Thailand
• United Kingdom (UK)

In the United States, the FDA’s Declaration of Conformity is built into the eSTAR program.

What is required in a Declaration of Conformity?

While the requirements vary slightly by country, a DoC should be provided on company letterhead and general requirements typically include:

• Standards related to the product that are compliant to a country’s regulations
• Product Name  
• Part Number  
• Physical and legal manufacturer details
• ISO Certificate Information  
• Classification of the device per the country regulations and the specific rule used to classify the device
• Notified Body details
• Distributor information  
• A statement regarding the regulation that the responsible party is stating compliance to
• A signature from the responsible party

Using a Regulatory Information Management (RIM) system, like Rimsys, to manage your product data and related standards will allow your regulatory team to create and control declarations of conformity and other documents. Learn more here.