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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:

  1. 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.
  2. A statement confirming that the declaration is issued under the sole responsibility of the manufacturer.
  3. The Basic UDI-DI (per Annex VI, Part C).
  4. 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.
  5. The device’s risk class according to the classification rules in Annex VIII.
  6. A statement that the device complies with this regulation and any other relevant EU legislation that requires a Declaration of Conformity.
  7. References to any Common Specifications (CS) applied for conformity.
  8. If applicable, the name and ID number of the notified body involved, a description of the conformity assessment procedure, and any relevant certificate numbers.
  9. Additional information, if necessary.
  10. 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.

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CE-marking process under IVDR

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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:

  1. 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.
  2. A statement confirming that the declaration is issued under the sole responsibility of the manufacturer.
  3. The Basic UDI-DI (per Annex VI, Part C).
  4. 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.
  5. The device’s risk class according to the classification rules in Annex VIII.
  6. A statement that the device complies with this regulation and any other relevant EU legislation that requires a Declaration of Conformity.
  7. References to any Common Specifications (CS) applied for conformity.
  8. If applicable, the name and ID number of the notified body involved, a description of the conformity assessment procedure, and any relevant certificate numbers.
  9. Additional information, if necessary.
  10. 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.

Further reading

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI) - what is it, where to obtain it, and what to do with it

EUDAMED registration - a brief guide

Contract with the Authorised Representative in the European Union (Authorised Representative Mandate)

GSPR – General Safety and Performance Requirements for medical devices in the European Union

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

IEC 62304 - the pivotal standard for software medical devices

Medical Device Regulation (MDR) - basics

ISO and IEC standards for medical device software

Clinical Evaluation, PMCF, and PMS in Medical Device Lifecycle

Notified Bodies and their role in certification of medical devices

What is NANDO and why medical device companies should know about it?

Labeling and UDI requirements for medical devices in the EU

Understanding the roles of Authorised Representatives and Importers under MDR/IVDR

MDR implementation - challenges and solutions

Post-market surveillance under MDR and IVDR - requirements and best practices

Notified Body audit - a manufacturer's guide

Risk management plan - guide for medical device companies

Should my medical device comply with GDPR?

EC-certificate for a medical device - Q&A

How long does it take to CE-mark a medical device?

What is a PRRC?

Essential requirements for importers and distributors under MDR and IVDR

Language requirements for IFUs and labels under the MDR and IVDR

Legal Manufacturer and Original Equipment Manufacturer in medical devices

How to structure a PRRC contract for effective compliance

How to Create a Declaration of Conformity According to MDR or IVDR

All articles >>

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Phone: +357 22253765
Email: info@mdrc-services.com
 

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Useful information

CE-Certificate vs. EC-Certificate

Basic UDI-DI (bUDI)

EUDAMED registration - a brief guide

Authorised Representative Mandate

GSPR – General Safety and Performance Requirements

How to obtain CE marking for medical software under the EU MDR or IVDR?

Technical documentation for Medical Device Software in the EU

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