How to write a Declaration of Conformity? (MDR and IVDR).

Declarations of Conformity - Guidance and common errors.

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How To Write A Declaration Of Conformity

What Is a Certificate of Conformity (COC), and How To Get.

A Declaration of Conformity is not a quality certificate, nor a guarantee for safety. However, when properly drawn up along with CE marking on the product, conformity of the product with the Directive(s) quoted on the Declaration of Conformity may be presumed by suppliers in the distribution chain and by the end customer, provided there are no obvious or known defects. Additionally, market.

How To Write A Declaration Of Conformity

How to create a Declaration of Conformity - CEM International.

The following four steps should help anyone with experience in CE marking to draw up their Declaration of Conformity: Select a relevant product group on the website of the European Commission. Read about the Declaration of Conformity in the content of each applicable Directive. Draw up the DoC.

How To Write A Declaration Of Conformity

Medical devices: conformity assessment and the CE mark.

EU declaration of conformity. An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law. How to draw.


Drafting a Declaration of Conformity is an important part of the CE marking process. It is the final step before affixing the CE mark to your product. Before writing the Declaration of Conformity, you must have carried out these steps: Identify the EU requirements for your product.

EU Declaration of Conformity - What is it for? How to make it?

Declaration of Conformity. Below is an example of a European Declaration of Conformity and an example form for a Declaration of Conformity: An Example of a Declaration of Conformity. Manufacturer: XYZ Corp. 325 Grassy Knoll Garden City, New York Telephone No. (516) 555-3333. Product: Walk-Behind Lawn Mower (3.5 HP) Model No. 3.5L Serial Number 350000-360000. The undersigned hereby declares, on.

Letter of Declaration - Sample Letter of Declaration.

As a general rule the DoC need only be a single page. For certain directives the declaration of conformity needs to form part of the user manual. Electronic versions of a declaration of conformity PDF, or other formats are useful as this will allow a manufacturer to send the document electronically should anyone require a copy.

CE Marking: Who is responsible for signing the Declaration.

The EU Declaration of Conformity is the document in which the manufacturer states that the product satisfies the essential requirements of the applicable legislation. By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product. The EU Declaration of Conformity must contain all relevant information to identify the EU.


Apply the CE mark to the product and complete the Declaration of Conformity. Only when all of the above have been properly completed is is legitimate for the product to bear the CE logo. The person who signs the Declaration should have the knowledge that these things have been done, and it would be appropriate for it to be someone whose management responsibility includes the processes that the.

Only at their conclusion, when the final product is safe, and when you have issued a Declaration of Conformity and affixed the CE mark, can the final product be brought into use or placed on the market. Partly completed machinery must come with instructions for incorporation, as well as a Declaration of Incorporation, and both these instructions and the Declaration of Incorporation should be.


The Declaration of Conformity is a legal Document which must accompany all CE Marked products sold in the European Union. Almost all new products must be supplied to the end user with a Declaration of Conformity. This document needs to include the following: Name and address of organisation taking responsibility for the product.

How To Write A Declaration Of Conformity

Declaration of Incorporation - Work equipment and machinery.

Declaration of Compliance (DOC) for Food Contact Materials. Little Pro on 2017-03-01 Views: Update:2019-11-16. EU's food contact legislation has set out mandatory requirement that business operators provide written declaration of compliance (DOC) for some types of food contact materials (i.e, plastics). China has similar requirements on DOC for food contact materials and containers.

How To Write A Declaration Of Conformity

What is a declaration of conformity?

Stage 2: Issuance of Shipment Certificate of Conformity (SCoC). Every regulated product included in the shipment will be verified whether valid PCoC exists for that product and if found to be true will be issued with the SCoC. The SCoC is valid for that specific shipment only. Request for Shipment Certificate of Conformity (SCoC) by Importer.

How To Write A Declaration Of Conformity

Declaration of Compliance (DOC) for Food Contact Materials.

After “ declare,” the person writing the declaration should type or print neatly in black or dark blue ink what they want to tell the judge. See below for suggestions. Using Documents and Confidential Information. To attach documents to Declarations, such as copies of bills, school records, medical or treatment records, you should refer to them in the declaration, explain what they are.

How To Write A Declaration Of Conformity


Declaration of Conformity. The Declaration of Conformity is an important legal document in which manufacturers declare the conformity of their medical devices. In this article you can read about the mistakes you absolutely have to avoid in order to make sure there are no legal consequences. Phrasing the declaration of conformity “correctly” Advice from the ZLG. If you want to write a.

How To Write A Declaration Of Conformity

Certificate of Conformity - Saudi Arabia.

How Declaration of Conformity (DoC) templates are created Posted by Rob Packard on January 15, 2014. This article about the declaration of conformity for medical device CE Marking identifies three possible sources for creating a template and includes recommendations for making the transition to the proposed EU Medical Device Regulation (EMDR).

How To Write A Declaration Of Conformity


The Declaration of Conformity should be drawn up in one of the official languages of the EU. However, member states of the EU might require the Declaration to be translated. When to Provide A Declaration Of Conformity. The Declaration of Conformity should be part of the technical file and made available upon request of market authorities. Only.

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