Declaration of Conformity (DoC) under MDR & IVDR
What Is a Declaration of Conformity (DoC)?
The Declaration of Conformity (DoC) is an official, legally binding document that a manufacturer prepares to confirm that their medical device or in vitro diagnostic device (IVD) fully complies with the applicable European regulations either the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746).
Think of the DoC as the manufacturer’s “public promise” to European regulators that the product is safe, effective, and meets all regulatory requirements before being placed on the EU market. It’s not just a formality it represents the manufacturer’s legal responsibility for ensuring ongoing compliance throughout the product’s entire life cycle.
The Role of the DoC in Major Markets
European Union (EU)
Under the MDR and IVDR, the DoC is mandatory for CE marking. A device cannot be marketed in the EU unless this declaration exists.
The DoC must follow Annex IV of the respective regulation, which lists the exact details to include, such as the manufacturer’s name, product identifiers, applicable standards, and conformity statement.
United Kingdom (UK)
After Brexit, the UK introduced its own version called the UK Declaration of Conformity, which supports the UKCA mark (replacing CE marking in Great Britain).
Manufacturers must reference the UK MDR 2002 (as amended) — which mirrors many EU requirements but is managed separately by the MHRA (Medicines and Healthcare products Regulatory Agency).
United States (USA)
The U.S. FDA does not require a Declaration of Conformity. Instead, manufacturers comply with 21 CFR Part 807 and Part 820, which involve device listing and Quality System Regulation (QSR) compliance. These serve the same purpose — to ensure that products are safe, effective, and properly manufactured.
Why the Declaration of Conformity Is So Important
The DoC acts as a compliance requirements for entering the European market. It serves several crucial purposes:
Accountability: It holds the manufacturer legally responsible for meeting MDR/IVDR requirements.
Transparency: It allows regulators, importers, and distributors to easily verify compliance.
Market Access: It confirms that the necessary conformity assessment procedures have been completed.
Traceability: It helps authorities track the manufacturer, device model, and applicable standards.
In other words, the DoC is more than just a piece of paper — it’s the official proof that the device is ready and compliant for sale across Europe.
Legal Basis under MDR and IVDR
Under Article 19 (MDR) and Article 17 (IVDR), the Declaration of Conformity must:
Declare that all regulatory requirements have been met.
Be kept up to date throughout the device’s life cycle.
Include the elements listed in Annex IV of the regulation.
Be available in the official language(s) of the EU Member State(s) where the device is sold.
Be signed by the manufacturer or their authorized representative (if located outside the EU).
If your product is also covered under other EU laws like RoHS (for hazardous substances) or REACH (for chemical safety), you can issue a single combined DoC referencing all applicable legislations.
By signing the DoC, the manufacturer assumes full legal responsibility for product compliance meaning any non-conformity could lead to enforcement actions, recalls, or penalties.
Mandatory Components of the Declaration of Conformity (Annex IV)
Annex IV of the MDR and IVDR provides a clear checklist of what every DoC must contain:
Manufacturer Details – Full name and address, plus Authorized Representative details (if outside the EU).
Product Information – Device name, model, and risk classification.
Identification Numbers – Basic UDI-DI or UDI-DI.
Applicable Legislation – Reference to the correct EU regulation and any other applicable laws.
Standards Applied – A list of harmonized standards or common specifications used.
Conformity Assessment Route – Indicate which annex (e.g., Annex IX, X, XI) was followed.
Official Statement – A clear declaration such as:
“The undersigned hereby declares that the device complies with Regulation (EU) 2017/745 / 2017/746 and all other applicable Union legislation.”Signature and Date – Signed by an authorized signatory, with place and date.
Each of these components ensures consistency, traceability, and legal validity across the EU market.
Step-by-Step Process for Creating a Compliant DoC
Identify the applicable regulation – Determine if your device falls under MDR or IVDR.
Complete conformity assessment procedures – Depending on your device class, this may involve self-certification or a Notified Body review.
Prepare technical documentation – Compile the technical file as per Annex II and III.
Obtain Notified Body certificate (if required) – For medium- or high-risk devices.
Draft the Declaration of Conformity – Follow the Annex IV structure exactly.
Translate the DoC – Into the language(s) of all EU Member States where the device is marketed.
Sign and maintain – Keep the signed DoC in your quality records and update it when necessary.
Example of an MDR/IVDR-Compliant Declaration of Conformity
EU Declaration of Conformity
Manufacturer: [Company Name]
Address: [Full Company Address]
Device Name: [Device Model/Name]
Regulation: (EU) 2017/745 / (EU) 2017/746
Basic UDI-DI: [Insert Number]
Conformity Assessment Route: [Annex IX / X / XI]
Statement:
“This Declaration of Conformity is issued under the sole responsibility of the manufacturer. The undersigned hereby declares that the device complies with the applicable requirements of Regulation (EU) 2017/745 / 2017/746.”
Place and Date: [City, Date]
Signature: [Authorized Signatory’s Name and Position]
How the DoC Differs from Other Compliance Documents
Document | Purpose | Issued By | Regulatory Role |
Declaration of Conformity (DoC) | Confirms regulatory compliance | Manufacturer | Mandatory self-declaration |
Notified Body Certificate | Verifies conformity for medium/high-risk devices | Notified Body | External verification |
Technical Documentation | Provides supporting compliance evidence | Manufacturer | Internal record, submitted on request |
In short:
The DoC is your public declaration of compliance.
The Technical File is your evidence proving compliance.
The Notified Body Certificate is your third-party validation when required.
All three work together to establish your product’s conformity foundation in the EU.
Maintaining and Updating the Declaration
Once issued, the DoC isn’t static — it must be reviewed and updated regularly, especially when:
There are design or manufacturing changes.
The applicable standards are revised.
A new Notified Body is involved.
The manufacturer’s address or AR changes.
Each update should be version-controlled and dated to ensure traceability.
Common Mistakes to Avoid
Missing or outdated standard references.
Incorrect Basic UDI-DI or device details.
Missing Authorized Representative information.
Untranslated DoC for target markets.
No authorized signature or date.
Even a small administrative error can delay CE marking or lead to compliance issues during audits.
Where the rules live (and why that matters)
MDR: Article 19 defines the DoC; Annex IV lists the required content.
IVDR: Article 17 defines the DoC; Annex IV lists the required content (same structure as MDR).
The law explicitly requires that the Declaration of Conformity (DoC) be kept up to date and include, at a minimum, all information specified in Annex IV of the EU MDR and IVDR.
Conclusion
The Declaration of Conformity (DoC) is a vital document that legally confirms a medical device or IVD complies with all requirements under the EU MDR and IVDR. It acts as the manufacturer’s formal assurance of safety, quality, and regulatory conformity, enabling market access across Europe. Maintaining an accurate and up-to-date DoC demonstrates accountability, supports audits, and strengthens trust with regulators and customers alike.
How Morulaa Can Help
Morulaa HealthTech supports manufacturers in creating and maintaining MDR- and IVDR-compliant Declarations of Conformity (DoC). Our team ensures the document meets all Annex IV requirements, aligns with technical files, and includes accurate Notified Body and UDI details. We also assist with updates, translations, and formatting, helping manufacturers stay compliant, avoid regulatory delays, and achieve smooth CE marking and EU market access.