How to Create a Declaration of Conformity According to MDR or IVDR
Creating a Declaration of Conformity (DoC) is an essential step for manufacturers of medical devices and in vitro diagnostic devices who wish to enter the European Union market. The DoC is an official document that confirms your device complies with all the requirements outlined in the MDR or IVDR. Here's a guide on how to create a DoC in line with these regulations.
The requirements for a Declaration of Conformity under both the MDR and IVDR are quite similar and are outlined in Annex IV of each regulation. This annex details the essential elements that must be included in the DoC.
Purpose of the Declaration of Conformity
The Declaration of Conformity is a legally binding document that certifies your device meets EU safety, quality, and performance standards. By signing the DoC, the manufacturer takes full responsibility for the compliance of their product, ensuring it conforms with all applicable requirements under MDR or IVDR.
Essential content of the DoC
The MDR and IVDR have specific requirements for what must be included in a Declaration of Conformity. Here are the core elements:
- The name, trade name, or trademark of the manufacturer, their SRN (if issued per Article 31), and, if applicable, details of their authorized representative, along with the address where they can be reached.
- A statement confirming that the declaration is issued under the sole responsibility of the manufacturer.
- The Basic UDI-DI (per Annex VI, Part C).
- The product's name, trade name, product code, catalog number, or any other identifier that allows for clear identification and traceability, such as a photo if appropriate, as well as the device’s intended purpose. Identification details can be provided by the Basic UDI-DI mentioned above.
- The device’s risk class according to the classification rules in Annex VIII.
- A statement that the device complies with this regulation and any other relevant EU legislation that requires a Declaration of Conformity.
- References to any Common Specifications (CS) applied for conformity.
- If applicable, the name and ID number of the notified body involved, a description of the conformity assessment procedure, and any relevant certificate numbers.
- Additional information, if necessary.
- The place and date of issue, the name and position of the person who signed the declaration, and an indication of their authority and on whose behalf they signed, including the signature.
Additional information can be included in the Declaration of Conformity, such as the intended purpose of the device, detailed descriptions, catalog numbers, and any other specifics that help clarify or identify the device. These extra details provide more context and enhance the traceability and transparency of the device covered by the declaration.
Declaration of Conformity template
With all required elements identified, you can draft the DoC. Here’s a basic template to get you started:
Declaration of Conformity
We, [Manufacturer’s Name], located at [Address], declare under our sole responsibility that the following product(s):
Product Name: [Name]
Model Number: [Model Number]
Batch/Serial Number: [Batch/Serial Number]
to which this declaration relates, is in conformity with the provisions of the Medical Device Regulation (EU) 2017/745 (MDR) or In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), in accordance with [Risk Classification].
The following harmonized standards and/or Common Specifications have been applied:
Standards: [List of Standards and CS, e.g., ISO 13485]
This product has undergone conformity assessment procedure [Conformity Assessment Procedure] as per [Article 52 of MDR / Article 48 of IVDR].
Notified Body involved: [Notified Body Name and Number], Certificate Number: [Certificate Number].
Date: [Date]
Place: [Location]
Signed by: [Name and Position]
Review and finalize the DoC
Before signing, ensure that all information is accurate and up-to-date. It’s wise to have the DoC reviewed by a compliance expert or legal advisor to confirm it meets all regulatory requirements and accurately reflects the device's compliance.
Store the signed Declaration of Conformity in a secure location as part of your technical documentation. You may need to present it to regulatory authorities, so it’s essential to keep it updated if there are any changes to the device or applicable standards. For ongoing compliance, regularly review the DoC in case of updated regulations, additional standards, or design changes.
