Ensuring compliance with global regulations starts with a well-prepared Declaration of Conformity —a key document that can make or break your approval process. Understanding best practices for its preparation can help you avoid regulatory roadblocks and streamline market access.
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What Is a Declaration of Conformity (DoC)?
A Declaration of Conformity (DoC) is a formal statement issued by a manufacturer or supplier to declare that their product meets the necessary regulatory and safety requirements set by relevant laws and standards. It is often used to demonstrate compliance with national or international regulations, such as those concerning safety, health, environmental impact, and electromagnetic compatibility.
A DoC typically includes:
- Product Identification: Information about the product, such as model number, type, or series.
- Manufacturer’s Details: Name and address of the manufacturer or the company issuing the declaration.
- Standards and Directives: The specific standards, regulations, or directives the product complies with such as the European Union’s CE marking requirements, RoHS (Restriction of Hazardous Substances), or others.
- Compliance Statements: A clear declaration that the product complies with the applicable regulations.
- Authorized Representative: Manufacturers outside a certain region, may designate an authorized representative within the region.
- Date and Signature: The date the declaration was issued and the signature of a responsible person from the company, often a compliance or technical manager.
The DoC is often required before a product can be sold in certain markets (e.g., CE marking in Europe or FCC certification in the U.S.) and is an important part of the regulatory approval process.
Regulatory Significance in Different Markets (EU, UK, US)
The Declaration of Conformity (DoC) for medical devices and in vitro diagnostic (IVD) devices is a key regulatory document required to market these products in various jurisdictions. It asserts that the device complies with relevant regulatory requirements, standards, and directives.
European Union (EU):
- For Medical Devices (MDR): Manufacturers must prepare a DoC stating that the device conforms to the requirements of the MDR. The DoC should include details such as the manufacturer’s name and address, device description, conformity assessment procedure, and references to relevant harmonized standards.
- For IVDs (IVDR): A similar process applies, but there are additional requirements depending on the classification of the IVD. For example, higher-risk IVDs, such as those used for screening or diagnostic purposes, require a more thorough assessment, including the involvement of a notified body.
United Kingdom (UK):
- For Medical Devices: The UK requires a DoC under the UK Medical Devices Regulations 2002, which aligns closely with the EU MDR but with specific amendments.
- The DoC for UK market access needs to include the same general information as the EU version but with reference to UK regulations instead of the EU MDR.
- For IVDs: Similarly, IVDs must meet the UK In Vitro Diagnostic Devices Regulations (replacing the IVDR post-Brexit). The DoC must confirm that the IVD complies with relevant UK standards, and, depending on the device classification, may require involvement from a UK Approved Body.
United States (US):
- For Medical Devices: The DoC is not explicitly required by the FDA in the same way it is in the EU or UK. However, manufacturers are required to provide 510(k) Premarket Notification or Premarket Approval (PMA), depending on the device classification (Class I, II, or III).
- For IVDs: IVDs are regulated under the Clinical Laboratory Improvement Amendments (CLIA) and FDA regulations. Similar to medical devices, IVDs need FDA approval or clearance, but the DoC concept is not as prominent.
Why Is the DoC Important for Medical Devices and IVDs?
The DoC serves as a crucial document for medical devices and in vitro diagnostic (IVD) devices because it serves as an official statement from the manufacturer that the product meets all relevant regulatory requirements, safety standards, and performance criteria.
Legal and Compliance Requirements
In many jurisdictions, including the European Union, the United Kingdom, and some other markets, the DoC is a mandatory requirement for medical devices and IVDs to be legally placed on the market. Without the DoC, manufacturers cannot sell their products in those markets, as it serves as proof that the device complies with local regulations, such as the EU’s Medical Device Regulation (MDR) or In Vitro Diagnostic Device Regulation (IVDR).
The DoC confirms that the device has been assessed and meets the essential safety and performance requirements as set out by regulatory bodies. For example, in the EU, the DoC verifies that the device complies with the European Union’s standards under the MDR/IVDR and any applicable harmonized standards.
This includes things like biocompatibility, electrical safety, and risk management practices.
Role in CE Marking and Global Market Access
Due to the pivotal role The Declaration of Conformity (DoC) plays in the CE marking process for medical devices and in vitro diagnostic (IVD) devices, this in turn influences global market access. In the EU, the CE mark is a symbol that signifies that a product conforms to all the relevant regulatory requirements, specifically the Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746.
The DoC is a core component of this process, as it serves as the formal statement that the product complies with these regulations and other applicable EU requirements.
EU MDR & IVDR Requirements for the Declaration of Conformity
The European Union Medical Device Regulation (EU MDR) 2017/746 provides the regulatory framework for medical devices and in vitro diagnostic (IVD) devices, respectively, within the European Union. Both regulations include specific requirements for the Declaration of Conformity (DoC), which serves as the manufacturer’s formal declaration that the device complies with all applicable EU regulations, standards, and safety/performance requirements.
Key Elements of a Compliant DoC under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)
The MDR outlines the regulatory requirements for medical devices, with the DoC being a central part of the process for placing a device on the market in the EU. The DoC under the MDR must demonstrate that the medical device meets the following requirements:
- Compliance with the MDR: The DoC must confirm that the device conforms to the essential requirements set out in the MDR, including safety, performance, and risk management standards.
- Harmonized Standards: If the device has been tested against harmonized European standards, the DoC must reference the specific standards. These standards help ensure that the device complies with the essential requirements of the MDR.
- Manufacturer’s Responsibilities: The DoC must indicate that the manufacturer has met their obligations, including risk management, clinical evaluation, and post-market surveillance.
- Conformity Assessment Procedure: The DoC should specify the conformity assessment procedure followed, depending on the classification of the device. FOr lower-risk devices (Class I), manufacturers can self-certify, but for higher-risk devices (Class IIa, IIb, III), a Notified Body must be involved.
- Device Classification: The classification of the device (Class I, IIa, IIb, III) must be mentioned in the DoC. The classification determines the level of regulatory scrutiny the device has undergone.
The IVDR governs the placing of in vitro diagnostic (IVD) devices on the EU market, and the DoC serves a similar purpose as in the MDR but has certain IVD-specific requirements.
The DoC under the IVDR must confirm compliance with the following:
- Compliance with IVDR Requirements: The DoC must state that the IVD conforms to essential requirements of the IVDR, including performance, safety, and quality requirements for the IVDs.
- Conformity with Harmonized Standards: The manufacturer must confirm whether the device conforms to any relevant harmonized European standards. Compliance with these standards is typically used to demonstrate conformity with the IVDR.
- Manufacturer’s Responsibilities: As with the MDR, the DoC must confirm that the manufacturer has adhered to the requirements for risk management, clinical performance, labeling, and post-market surveillance.
- Conformity Assessment Procedure: Similar to the MDR, the DoC should specify the conformity assessment procedure. The classification of the IVD determines whether a self-declaration is sufficient or if a Notified Body is required. IVDs are classified into four risk categories (Class A, B, C, D), with Class D being the highest risk.
- Notified Body Involvement (if applicable): If a higher-risk IVD (Class B, C, or D) is involved, the DoC must reference the Notified Body’s name and identification number, confirming its involvement in the conformity assessment process.
How to Draft a Compliant Declaration of Conformity
Drafting a compliant Declaration of Conformity (DoC) for medical devices and in vitro diagnostic (IVD) devices involves ensuring that the document meets the regulatory requirements set forth by the relevant regulations, such as the EU Medical Device Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Regulation (IVDR) 2017/746.
Step-by-step Guide on Required Content
- Title of the Declaration: Start by clearly labeling the document as the “Declaration of Conformity.”
- Manufacturer’s Information: The name and address of the manufacturer of the device must be provided. If the manufacturer is based outside the EU, the name and address of the authorized representative in the EU must also be included.
Example:- Manufacturer’s Name: [Manufacturer’s Company Name]
- Manufacturer’s Address: [Full Address, City, Country]
- Authorized Representative (if applicable): [Name and Address of Authorized Representative in the EU]
- Device Identification: You must provide clear identification of the device being declared, including the device name or model, product codes (if applicable), Unique Device Identification (UDI) if required, and a short description of the device, highlighting its intended purpose and characteristics.
Example:- Device Name: [Device Name]
- Model Number: [Model Number]
- UDI: [UDI Number]
- Device Description: [Brief Description of the Device, e.g., “Surgical instrument used for minimally invasive procedures”]
- Conformity with Applicable Legislation: The DoC should specify the regulations and directives the device complies with, particularly the EU MDR or IVDR, and reference any relevant harmonized standards that the device conforms to.
Example:- Regulation: “This device is in conformity with the requirements of Regulation (EU) 2017/745 on medical devices (MDR).”
- Harmonized Standards: “This device conforms to the following harmonized standards: EN 60601-1 (Medical Electrical Equipment) and EN ISO 14971 (Risk Management for Medical Devices).”
- Other References: “This device complies with the relevant provisions of Directive 93/42/EEC (for legacy devices) if applicable).”
- Conformity Assessment Procedure: Describe the conformity assessment procedure followed by the manufacturer to ensure that the device complies with the applicable regulations. The procedure depends on the device classification (Class I, IIa, IIb, III for MDR or A, B, C, D for IVDR).
Example:- Conformity Assessment: “The device has been assessed by Notified Body [Name] under the conformity assessment procedure [Annex X of MDR] for Class IIa devices (CE certificate number 1234).”
- Manufacturer’s Declaration of Conformity: A statement confirming that the manufacturer takes full responsibility for the device’s compliance with applicable regulations.
Example:- Statement: “We, [Manufacturer Name], declare under our sole responsibility that the device [Device Name] conforms to the provisions of Regulation (EU) 2017/745 and the harmonized standards referenced in this declaration.”
- Authorized Signatory: The name, title, and signature of the individual(s) authorized by the manufacturer to sign the DoC must be included. This is typically a senior representative (e.g., CEO, Regulatory Affairs Manager).
Example:- Name: [Name of Authorized Person]
- Title: [Title of Authorized Person]
- Signature: [Signature]
- Date: [Date of Signing]
- Device Class (for MDR/IVDR): Identify the classification of the device according to the EU MDR or IVDR, which determines the level of regulatory scrutiny required for market access.
Example:- Device Class: “Class IIa (MDR)” or “Class D (IVDR)”
- Notified Bodies (if applicable): For higher-risk devices that require Notified Body involvement (Class IIa, IIb, II for MDR or Class B, C, D for IVDR), the DoC should specify the name and identification number of the Notified Body that assessed the device.
Example:- Device Class: “Class IIa (MDR)” or “Class D (IVDR)”
Template Example for MDR/IVDR Compliance
DECLARATION OF CONFORMITY
Manufacturer:
[Manufacturer Name] [Manufacturer Address]Authorized Representative (if applicable):
[Authorized Representative Name] [Authorized Representative Address]Device Name:
[Device Name]Model Number:
[Model Number]UDI:
[UDI Number]We, the undersigned declare under our sole responsibility that the device described above is in conformity with the provisions of the Regulation (EU) 2017/745 (Medical Devices Regulation), as amended, and the harmonized standards listed below:
- EN 60601-1: Medical Electrical Equipment
- ISO 14971: Risk Management for Medical Devices
This device has been assessed under the conformity assessment procedure of Class IIa and has been approved by Notified Body [Notified Body Name], ID Number: [Notified Body ID Number].
We further declare that the device meets the essential requirements for safety, performance, and risk management as outlined in the EU MDR.
Date: [Date]
Signature: [Authorized Person’s Signature]
Name: [Authorized Person’s Name]
Title: [Authorized Person’s Title]
Declaration of Conformity vs. Other Regulatory Documents
Understanding the difference between the Declaration of Conformity (DoC), Technical Documentation, and Notified Body Certificates is crucial for manufacturers navigating medical device and in vitro diagnostic (IVD) compliance processes. Each serves a distinct role in the regulatory landscape.
Difference between DoC, Technical Documentation, and Notified Body Certificates
Declaration of Conformity:
The Declaration of Conformity (DoC) is a formal, legally binding document where the manufacturer declares that a medical device or IVD complies with all applicable regulatory requirements (e.g., EU MDR or IVDR). This document must be signed by an authorized representative of the manufacturer, confirming compliance with the essential safety and performance requirements of the relevant regulation.
A DoC is required for all devices placed on the EU market, regardless of their classification. Class I devices (MDR) and Class A IVDs (IVDR) can be self-certified by the manufacturer.
Technical Documentation:
The Technical Documentation (also known as the Technical File or Design Dossier) contains comprehensive information about the design, manufacturing, performance, and risk management of a medical device or IVD. It also provides evidence that the device meets regulatory requirements and serves as the primary document for regulatory review by Notified Bodies (if applicable) and regulatory authorities.
This documentation is mandatory for all devices, including self-certified ones, and must be available for inspection upon request. Class IIa, IIb, and III devices (MDR) and Class B, C, and D IVDs (IVDR) also require detailed Technical Documentation reviewed by a Notified Body.
Notified Body Certificates:
A Notified Body Certificate is an official document issued by a Notified Body after reviewing the manufacturer’s Technical Documentation and quality management system for higher-risk devices. This document also confirms that an independent third party has verified the conformity of the device.
This special certification is required for Class IIa, IIb, and III devices (MDR) and for Class B, C, D devices (IVDR). However, it is not required for Class I (MDR) and Class A (IVDR) devices unless they have sterile, measuring, or reusable surgical instruments.
How RegDesk Simplifies the Declaration of Conformity Process
RegDesk offers a comprehensive platform designed to streamline the Declaration of Conformity (DoC) process for medical device manufacturers by automating compliance document management, providing real-time regulatory intelligence, and enhancing submission and approval workflows.
Automating Compliance Document Management
RegDesk’s AI Form Builder automates the creation of essential compliance documents, including the DoC, General Safety and Performance Requirements (GSPR) checklists, and Essential Requirements (ER) checklists. The platform also tracks changes in standards, ensuring that all compliance documents remain up-to-date.
Real-time Regulatory Intelligence to Stay Updated on DoC Requirements
The platform provides real-time regulatory intelligence, keeping users informed about current and upcoming regulations globally. This feature ensures that manufacturers stay updated on DoC requirements across different markets, facilitating proactive compliance management.
Streamlining Submission and Approval Workflows
RegDesk’s Regulatory Information Management System (RIMS) offers AI-driven tools that simplify submission preparation by converting complex requirements into easy, fillable forms. The platform automatically generates jurisdiction-specific, submission-ready dossiers, reducing manual effort and expediting product approvals.
By integrating these capabilities, RegDesk simplifies the DoC process, enabling medical device manufacturers to manage compliance more efficiently and effectively.
Final Checklist Before Submitting Your Declaration of Conformity
Before submitting a Declaration of Conformity (DoC), it’s essential to ensure that all requirements are met and that the document aligns with relevant regulations (such as EU MDR 2017/745) or IVDR 2017/746).
In order to verify compliance and accuracy utilize this comprehensive checklist to ensure you’re equipped:
- Document Title and Clear Identification
- Manufacturer and Authorized Representative Information
- Compliance Statement
- Applicable Standards and Regulations
- Notified Body Information (if applicable)
- Conformity Assessment Pathway
- Risk Management and Clinical/Performance Evaluation
- Device Traceability Information
- Post-Market Surveillance (PMS) and Vigilance Compliance
- Signatory Information
- Language Requirements
- Supporting Documentation
A well-prepared and compliant DoC ensures smoother regulatory submissions and faster market access. It also demonstrates the manufacturer’s commitment to quality, safety, and regulatory integrity.
Conclusion
The Declaration of Conformity (DoC) is far more than a regulatory requirement. By carefully crafting a comprehensive and accurate DoC, medical device and IVD manufacturers can streamline regulatory approvals, demonstrate accountability, and gain smoother access to global markets.
Ensuring the DoC aligns with regulations such as the EU MDR and IVDR, backed by thorough technical documentation and, where required, Notified Body involvement, helps safeguard compliance while reinforcing trust with regulatory authorities and end-users.
