EU Declaration of Conformity
The EU Declaration of Conformity template is a mandatory requirement according to the new medical device regulation and the in-vitro diagnostic device regulation. It is required to keep signed and dated DOC for MDs / IVDs that have affixed the CE Mark.
DOC is a document in which the manufacturer declares that the medical device/in-vitro diagnostic device complies with the requirements of MDR/IVDR and all the Union legislation applicable to the device. The DOC needs to be continuously updated by the manufacturer. The EU MDR Declaration of Conformity must be prepared as per MDR 2017/745, article 19 & annexe IV for Medical Devices and IVDR 2017/746 article 17 & annexe IV for Diagnostic Devices.
It should be translated into an official EU language or languages required by the Member State(s) in which the device is made available. It should be maintained by the manufacturer for 10 years after the last device has been placed on the market and for an implantable device for 15 years after the last device has been placed on the market.
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Why MDR Declaration of Conformity?
By preparing and signing the Declaration of Conformity(DOC), the manufacturer holds responsibility for compliance with the requirements of EU MDR 2017/745 Regulation and all other Union legislation applicable to the device
- An important part of the product’s technical documentation or technical file.
- Requires during EU Registration
- Needs at Port of Entry
- Your buyer needs it
Contents of MDR Declaration of Conformity
The following are the important contents in the Declaration of Conformity which is an integral part of the Technical Documentation for any class of device. The EU DOC must be on the company’s official letterhead.
- Name and full address of the manufacturer.
- Medical Device Name.
- Brand Name (If the applicable model/variant).
- Device Risk Classification.
- List of Harmonized Standards applied.
- Declaration statement.
- European Authorized Representative Name, full address, and contact information
- Notified Body name and Address (Not applicable for Class I devices).
- Name and designation of the person authorized to sign.
- Signature of the authorized person.
- Date and place of signing the DOC.
We provide service for technical documentation, Testing, Clinical Evaluation, Risk Analysis, and EU Representative service. Interested contact us
Buy ready-to-use EU MDR Declaration of Conformity Template
Easy to edit and use word files suitable for MDR & IVDR technical Files. Customers have the choice to purchase specific EU Declaration of Conformity Template based on the class and medical device. The supplied documents must be edited according to suitability and specific device characteristics and standards.
Note: Purchased DOC templates will be sent by mail with a link to download the file within 6 hours time manually. MDR DOC Templates are developed by an in-house team based on guidance documents and experience. No complaints and moneyback requests entertained for electronic document sale.
| MDD Class I DOC: 75 USD
Template ID: I3C-TEM-62 |
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| MDR Class I Declaration of Conformity: 150 USD
Template ID: I3C-TEM-63 |
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| MDD Class Is / Im / IIa / IIb / III DOC : 100 USD
Template ID: I3C-TEM-64 |
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| MDR Class Is / Im / Ir / IIa / IIb / III DOC : 175 USD
Template ID: I3C-TEM-65 |
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| IVD Class A DOC: 75 USD
Template ID: I3C-TEM-66 |
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| IVD Class B / C / D DOC : 175 USD
Template ID: I3C-TEM-67 |
EU Declaration of Conformity Drafting Service as per MDR & IVDR
We develop High-Quality EU Declaration of Conformity Template for all classes of devices in 1-2 working days for very economic fees. Customers must provide product-specific standards.
| Class I & A | Class Is/ Im/Ir /IIa & B | Class IIb/III & D/C |
| 450 Euros | 650 Euros | 850 Euros |
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Above fees applicable for single Construction /Design |
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Frequently Asked Questions
How much it will cost I3CGLOBAL to prepare a DOC for a manufacturing company?
What is the major difference between MDR and IVDR declaration of conformity?
- Product risk classification and rule
- Harmonized standards
- Declaration Statements
Core sections in a Declaration of Conformity
- Manufacturer name, address and SRN Number
- EU Authorized Representative details including SRN (If applicable)
- Basic UDI-DI
- Product details
- Risk class and rule(s)
- Notified Body and Notified Body certificate details
- Conformity assessment procedure
- Formal statements and contents