The Medical Device Regulations impose an obligation for the manufacturer to draw up a Declaration of Conformity (or ‘EU Declaration of Conformity’) as a part of the conformity assessment procedure. The Declaration must be issued before the medical device is placed on the market in Europe.
This document on Declaration of Conformity is an evidence that the manufacturer of a CE marked medical device confirm its compliance to the safety and performance requirements of the applicable legislation.
This document on Declaration of Conformity can be considered like a promise on the honor that the manufacturer respect the rules defined. This document represent a legal obligation.
The Declaration of Conformity (DoC) should be created and signed after the technical file is compiled. It should be done after the manufacturer is ready to guarantee that their product meets the requirements of specified EU regulations and other relevant standards. By drawing up and signing the EU Declaration of Conformity (DoC), the manufacturer assumes responsibility for the compliance of the product.
As the product’s manufacturer, you bear the sole responsibility for declaring conformity with all requirements. Before doing so, you must:
- Ensure conformity with all relevant EU-wide requirements.
- Determine whether you can assess your product by yourself or if you have to involve a notified body.
- Assemble a technical dossier documenting conformity.
- Draft and sign an EU declaration of conformity.
Once your medical device bears the CE marking — if the competent national authority requests — you must provide them with all the information and supporting documentation.
Responsible Person: The Declaration of Conformity (DoC) need to be signed by the Management Representative / Person responsible for Regulatory compliance / Owner of the company, which will give him the power and responsibility to say that the product have fulfilled all the applicable requirements.
CONTENTS OF (Declaration of Conformity) DoC AS PER ANNEX-IV OF MDR:
| Identification of company |
Name
Trademark |
| Single Registration number (SRN) |
Manufacturer SRN
Authorized representative SRN |
| Contact Details |
Place of Business
Manufacturer
Authorized representative |
| Basic UDI-DI |
For device identification |
| Product Identification |
Name
Tradename
Code
Catalogue number
Intended Purpose
Other reference |
| Risk Class |
As defined by Annex VIII of the Medical Device Regulation MDR 2017/745 |
| Common Specifications (CS) & Applicable standards |
List the standards or Common Specifications used for the device. |
| Notified Body |
Name
NB identification number
Description of the conformity procedure
The CE certificate number |
| Any other information |
This is up to each manufacturer |
| Statements |
This declaration of conformity (DoC) is issued under the sole responsibility of [insert Manufacturer name]
The device covered by the present EU declaration is in conformity with the EU MDR 2017/745 and with the [OTHER UNION LEGISLATION applicable] |
| Signature |
Place and date of issue
Name and function of the person who signed
If applicable the indication for and on behalf of who this person signed
signature |
For more information, Contact
MAVEN PROFCON SERVICES LLP
E-mail us at: enquiry@mavenprofserv.com
