If you’re a medical device manufacturer aiming to market your product in the European Union, understanding the Declaration of Conformity (DoC) is crucial. This legally binding document affirms that your device complies with all applicable EU regulations, most notably the Medical Device Regulation (MDR) 2017/745 or the In Vitro Diagnostic Regulation (IVDR) 2017/746.
The DoC is not merely a formality; it’s a first step in affixing the CE marking to your device, signaling its compliance with EU standards. Failing to prepare an accurate and complete DoC can lead to significant delays, regulatory penalties, or even product recalls.
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Why the Declaration of Conformity Matters
Under the MDR and IVDR, the DoC serves as a declaration by the manufacturer that the medical device complies with all relevant EU legislation. It reflects the outcome of the conformity assessment process and signals adherence to the General Safety and Performance Requirements (GSPR) set forth in the Annex I of the MDR.
The MDR Declaration of Conformity must be issued before the product is placed on the EU market or put into service. It is one of the key documents that authorities will ask to review in case of inspections, audits, or post-market surveillance activities.
Because it directly connects the product to its technical, regulatory, and safety documentation, the DoC essentially acts as a bridge between compliance and commercialization.
Who Must Create A Declaration of Conformity?
The responsibility for preparing and signing the Declaration of Conformity lies solely with the manufacturer of the medical device. This applies regardless of whether the manufacturer is based in the EU or outside of it.
Distributors and importers cannot issue a DoC. However, if the manufacturer is located outside the EU, they must appoint an authorized representative based in the EU.
This representative’s details must be included in the DoC, although they are not responsible for signing it.
What to Include in a Medical Device Declaration of Conformity
These include:
- Manufacturer Name & Address: The full legal name and address of the manufacturer, or the authorized representative if the manufacturer is outside the EU.
- Basic UDI-DI: The Basic Unique Device Identifier (UDI) assigned to the device, which aids in traceability and identification throughout its lifecycle.
- Product Identification: This includes the product’s name, model number, and any other identifiers that ensure traceability.
- Applicable EU legislation: A reference to the specific EU regulations the device complies with, such as MDR 2017/745 or IVDR 2017/746.
- Conformity Assessment Procedure: Details of the procedure followed to assess conformity, including the involvement of a Notified Body if applicable.
- Notified Body Details: If a Notified Body was involved, their name, identification number, and the certificate number should be included.
- Signed Statement of Conformity: A declaration that the device complies with all applicable requirements, signed by an authorized person within the manufacturer’s organization.
If you’re unsure where to start, using a DoC template for medical devices can be incredibly helpful. These templates ensure you cover all required fields and maintain consistency across product lines.
When and Where to Use the DoC
The Declaration of Conformity must be completed before placing the product on the market. Once prepared, the DoC becomes part of your device’s technical documentation, which must be retained for at least 10 years after the last device has been placed on the market (15 years for implantable devices).
While the DoC doesn’t need to be submitted proactively to regulators, it must be made available on request. If your device falls under a classification that requires Notified Body involvement (e.g., Class IIa, IIb, III), the declaration must also be submitted to them as part of the conformity assessment process.
Maintaining a well-organized document management system is essential for ensuring that your technical documentation under MDR is complete, up to date, and audit-ready.
Common Mistakes to Avoid
Despite its importance, many manufacturers make avoidable errors in their Declaration of Conformity.
Here are a few obstacles to watch for:
- Generic or vague language: Using non-specific terms that don’t accurately describe the device can lead to confusion or misinterpretation.
- Missing references to applicable EU regulations: Failing to cite the specific regulations the device complies with can undermine the DoC’s validity.
- Omitting signatures or using an unauthorized signatory: The DoC must be signed by an authorized person within the manufacturer’s organization to be valid.
- Not aligning the declaration with the device’s labeling or specifications: Discrepancies between the DoC and other documentation can raise red flags during inspections.
Taking the time to double-check your declaration for accuracy, completeness, and clarity can prevent major compliance headaches down the line.
Conclusion
The Declaration of Conformity is much more than a regulatory checkbox, it is an important element of your compliance strategy and a clear signal to regulators, partners, and consumers that your medical device meets the highest safety and performance standards.
By understanding who is responsible, what the declaration must include, and how to maintain it properly, you can reduce compliance risks and accelerate your path to market. If you’re managing multiple products or navigating complex regulatory pathways, consider using digital tools like RegDesk to automate and simplify compliance.
These platforms can help you keep your DoCs, technical files, and regulatory submissions organized and inspection-ready at all times.
Ready to simplify compliance for your medical devices?
Schedule a demo with RegDesk and discover how to manage global regulatory requirements more efficiently and confidently.
Author: Taylor Esser
