Declaration of Conformity
EU Declaration Of Conformity
Issue formal legal statement declaring device compliance with EU regulatory requirements for CE marking.
Summary
The EU Declaration of Conformity is a formal legal statement where you, as the manufacturer, declare under your sole responsibility that your medical device complies with all applicable regulatory requirements. This document serves as your official certification that the device meets EU MDR 2017/745 standards and can be legally placed on the European market.Why is EU Declaration of Conformity important?
The EU Declaration of Conformity represents the final regulatory milestone before market entry in the EU. Without this document, you cannot legally sell your medical device in Europe. It serves as your legal guarantee to regulatory authorities, healthcare providers, and patients that your device has undergone proper conformity assessment procedures and meets all essential safety and performance requirements. This document also provides legal protection for your company by demonstrating due diligence in regulatory compliance and establishes traceability for post-market surveillance activities.Regulatory Context
Under EU MDR 2017/745:- Article 19 mandates the Declaration of Conformity for all medical devices
- Annex IV specifies the exact content requirements
- Must be issued before CE marking and market placement
- Required for all device classes with different conformity assessment routes
Special attention required for:
- Class I devices (non-sterile, non-measuring, non-reusable): Self-declaration based on technical documentation
- Class I (sterile, measuring, reusable), IIa, IIb, III: Notified body involvement required
- Basic UDI-DI must be included and registered in EUDAMED
- Person Responsible for Regulatory Compliance (PRRC) must be identified
Guide
Your EU Declaration of Conformity must include specific mandatory elements as defined by Annex IV of MDR 2017/745. The document structure follows a standardized format that regulatory authorities expect to see.Essential Information Requirements
Manufacturer Details: Include your complete legal name, registered address, and contact information. If you’re not EU-based, you must also include your authorized representative’s details who acts on your behalf within the EU. Device Identification: Provide your device’s product/trade name, software version, Basic UDI-DI, and intended purpose. The intended purpose must match exactly what you’ve defined in your technical documentation and cannot be broader than what you’ve validated. Classification Information: State your device’s classification (Class I, IIa, IIb, or III) and provide the classification rule justification. This determines which conformity assessment procedure applies to your device.Conformity Assessment Declaration
The conformity assessment section varies based on your device class: Class I (non-sterile, non-measuring, non-reusable): Declare that conformity was demonstrated by drawing up technical documentation according to Annexes II and III and issuing the declaration according to Article 19 and Annex IV. Class I (sterile, measuring, reusable) and higher classes: Reference the specific Annex IX procedures followed and include your notified body’s name and identification number if applicable.Technical Standards Compliance
Include an Annex A listing all applicable technical standards your device complies with, such as:- EN ISO 13485:2016 for quality management systems
- ISO 14971:2019 for risk management
- IEC 62304:2006 for medical device software
- IEC 62366-1:2015 for usability engineering
Signature Requirements
The EU declaration must be signed by someone with authority to bind the manufacturer legally. Typically this includes:- CEO or Managing Director representing overall company responsibility
- Person Responsible for Regulatory Compliance (PRRC) confirming regulatory oversight
Document Control
Assign a unique document identifier and maintain version control. The EU declaration must be kept available for 10 years after the last device covered by it has been placed on the market.Example
Scenario
You’ve developed a Class IIa software medical device for cardiac monitoring. After completing your technical documentation, risk management, clinical evaluation, and notified body assessment, you’re ready to create your Declaration of Conformity. Your notified body has issued a certificate confirming compliance with Annex IX procedures.Example EU Declaration of Conformity
EU Declaration of Conformity ID: DOC-001-2024 The EU Declaration of Conformity is issued under the sole responsibility of the manufacturer. This document is a formal statement by the manufacturer that the medical device described below conforms to the requirements of the Medical Device Regulation (MDR) 2017/745. Manufacturer Information Legal Manufacturer:CardioTech Solutions GmbH Manufacturer Address:
Hauptstraße 123
10115 Berlin, Germany Regulatory Contact Information
Dr. Sarah Mueller, PRRC
Email: regulatory@cardiotech.de
Phone: +49 30 12345678 Medical Device Information Product/Trade Name:
CardioMonitor Pro Software Version:
v2.1.0 Basic UDI-DI:
4012345678901 Intended Purpose:
Software for continuous monitoring and analysis of cardiac rhythm patterns in hospital settings for healthcare professionals. Medical Device Classification Information Medical Device Class:
Class IIa Classification Rule Justification:
According to Rule 11 of Annex VIII, software intended to provide information for decisions with diagnosis or therapeutic purposes is classified as Class IIa. Conformity Assessment According to Article 52, conformity assessment was performed according to Chapters I and III of Annex IX of the Regulation (EU) 2017/745. Notified Body TÜV SÜD Product Service GmbH (NB 0123) The Medical Device referenced above meets the provisions of Regulation (EU) 2017/745 on medical devices. For a full list of applicable technical standards for the device, refer to Annex A. Name: Dr. Michael Weber
Title: CEO
Signature: [Signature] Name: Dr. Sarah Mueller
Title: Person Responsible for Regulatory Compliance (PRRC)
Signature: [Signature] Annex A - List of Applicable Technical Standards
| Standard Number | Standard Name |
|---|---|
| EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes |
| ISO 14971:2019 | Medical devices - Application of risk management to medical devices |
| IEC 62304:2006 | Medical device software - Software life cycle processes |
| IEC 62366-1:2015 | Medical devices - Application of usability engineering to medical devices |
Q&A
Do I need to translate my EU Declaration of Conformity for different EU markets?
Do I need to translate my EU Declaration of Conformity for different EU markets?
Yes, the EU Declaration of Conformity must be in the local language of each target market where you plan to sell your device. For initial market entry, create a comprehensive English master version first, then translate into required local languages. This is a legal requirement under MDR Article 10(11).
When exactly can I issue my EU Declaration of Conformity?
When exactly can I issue my EU Declaration of Conformity?
For Class I devices (non-sterile, non-measuring, non-reusable), you can issue the EU declaration once your technical documentation is complete and demonstrates compliance. For higher classes or special Class I devices, you must wait until your notified body has completed the conformity assessment and issued the relevant certificates.
What happens if I need to update my EU Declaration of Conformity?
What happens if I need to update my EU Declaration of Conformity?
You must issue a new EU Declaration of Conformity whenever there are significant changes to your device, such as software updates that affect safety or performance, changes in intended use, or modifications to your quality management system. Minor updates like bug fixes typically don’t require a new declaration, but document the rationale in your change control records.
Who has the authority to sign the EU Declaration of Conformity?
Who has the authority to sign the EU Declaration of Conformity?
How long must I keep my EU Declaration of Conformity?
How long must I keep my EU Declaration of Conformity?
You must maintain the EU Declaration of Conformity for at least 10 years after the last device covered by the declaration has been placed on the market. This is required under MDR Article 10(8) and is essential for post-market surveillance and regulatory inspections.