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Summary

You must issue a formal legal declaration stating that your medical device complies with all applicable EU MDR requirements before placing it on the European market. The Declaration of Conformity serves as your official certification that demonstrates compliance with essential safety and performance requirements while providing the legal foundation for CE marking and commercial distribution.

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Regulatory Context

Under EU MDR 2017/745 Article 19 and Annex IV, you must comply with:
  • Declaration of Conformity mandatory per Article 19 before market placement
  • Annex IV content requirements for declaration structure and information
  • Conformity assessment completion per applicable annexes (IX, X, XI)
  • Technical documentation supporting all conformity claims per Annex II
  • Basic UDI-DI inclusion and EUDAMED registration per Article 27
Special attention required for:
  • Person Responsible for Regulatory Compliance identification per Article 15
  • Notified body assessment completion for higher-risk devices
  • Authorized representative information for non-EU manufacturers per Article 11
  • CE marking validity ensuring continued compliance with essential requirements

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Overview

The Declaration of Conformity represents your formal legal commitment to regulatory compliance by officially certifying that your medical device meets all applicable EU MDR requirements and can be safely placed on the European market. This critical document transforms your technical compliance activities into legal market authorization while establishing accountability for ongoing regulatory obligations and post-market performance. EU Declaration of Conformity Creation requires systematic compilation of all compliance evidence into a formal legal statement that follows the mandatory structure defined in Annex IV of EU MDR 2017/745. The declaration process involves documenting your device identification information, manufacturer details, conformity assessment pathway, applied standards, and regulatory oversight arrangements while ensuring that all statements are supported by objective evidence in your technical documentation. Declaration creation requires careful attention to legal language and accuracy since this document represents your formal liability acceptance for device compliance and safety performance. Manufacturer Information Documentation establishes your legal identity and accountability by providing complete details about your organization, regulatory contacts, and authorized representatives where applicable. Manufacturer information must include your legal company name and registered address, contact information for regulatory inquiries, identification of your Person Responsible for Regulatory Compliance (PRRC), and authorized representative details if you are not EU-based. This information enables regulatory authorities to establish clear accountability chains while providing contact mechanisms for post-market surveillance and regulatory communication. Device Identification and Classification provides comprehensive technical details that enable regulatory authorities to understand your device’s characteristics, intended use, and appropriate regulatory treatment. Device identification must include your product name, software version, Basic UDI-DI, intended purpose statement, device classification with rule justification, and EMDN code selection. Accurate device identification ensures that regulatory authorities can properly categorize your device while enabling effective post-market surveillance and market oversight activities. Conformity Assessment Documentation establishes the regulatory pathway you followed to demonstrate compliance with EU MDR requirements while providing evidence that appropriate oversight was conducted. Conformity assessment documentation varies by device classification but includes identification of applicable conformity assessment annexes, notified body information for higher-risk devices, reference to supporting technical documentation, and confirmation that all required assessment activities were completed. This documentation provides regulatory authorities with confidence that systematic compliance verification was conducted according to established requirements. Applied Standards and Compliance Evidence demonstrates your systematic approach to regulatory compliance by documenting all harmonized standards, technical specifications, and regulatory requirements that were applied during device development. Standards documentation includes comprehensive listing of applied harmonized standards such as EN ISO 13485, ISO 14971, and IEC 62304, explanation of how each standard supports compliance with specific essential requirements, and reference to verification evidence that demonstrates standards compliance. Complete standards documentation provides presumption of conformity while supporting regulatory review and post-market evaluation activities. Legal Signature and Authorization establishes formal accountability by ensuring that appropriate personnel with legal authority take responsibility for compliance declarations and ongoing regulatory obligations. Signature requirements include identification of personnel with authority to bind the manufacturer legally, confirmation that signatories understand their regulatory responsibilities and potential liability, and documentation of signing authority through corporate governance structures. Proper signature authorization ensures that declaration commitments are legally binding while establishing clear accountability for ongoing compliance maintenance. Version Control and Maintenance ensures that Declaration of Conformity documents remain current and accurate throughout your device’s commercial lifecycle while supporting change control and regulatory communication requirements. Maintenance activities include establishing unique document identification and version control, implementing systematic review procedures for regulatory changes and device modifications, maintaining archives for required retention periods, and establishing procedures for declaration updates when necessary. Effective version control prevents compliance gaps while ensuring that regulatory authorities have access to current and accurate compliance documentation. Integration with CE Marking establishes the direct connection between your Declaration of Conformity and your legal authorization to affix CE marking and place devices on the European market. CE marking integration includes verification that all declaration requirements are satisfied before marking application, confirmation that technical documentation supports all declaration statements, and establishment of procedures for maintaining marking validity throughout commercial distribution. Proper integration ensures that CE marking accurately reflects compliance status while preventing premature or invalid market placement. Post-Market Obligations Integration ensures that your Declaration of Conformity commitments are supported by ongoing systems and procedures that maintain compliance throughout the commercial device lifecycle. Post-market integration includes establishment of surveillance systems that monitor continued compliance with declared requirements, procedures for updating declarations when device changes affect compliance status, and systems for communicating with regulatory authorities about compliance issues or changes. Effective post-market integration ensures that declaration commitments remain valid while supporting ongoing regulatory obligations and patient safety. Your Declaration of Conformity activities must demonstrate systematic regulatory compliance while establishing the legal foundation for market authorization and commercial success. Well-executed declaration processes provide regulatory confidence, prevent market access delays, and establish credible accountability frameworks that support long-term commercial success while maintaining public trust in device safety and effectiveness.