Eu declaration of conformity example

Proposed Classifications for Products without a Medical Intended Purpose

MDCG Solutions: Notified Body Capacity & Manufacturer Readiness

A Declaration of Conformity (DoC) is a legally binding document, in which the manufacturer asserts they have met the minimum requirements of the applicable legislation. For example, CE Marking to the EU MDR or UKCA Marking to the UK Medical Devices Regulation 2022.

Please find below EU and UK Declaration of Conformity templates available for download in word format.

NOTE: a DoC template is not provided for Switzerland. Non-Swiss manufacturers must obtain CE Marking and appoint a Swiss Authorized Representative in order to market in Switzerland. However, at this time, manufacturers are not required to generate a Swiss-specific DoC and may use their EU DoC with no changes.

For more information, please read: Declaration of Conformity Requirements

Europe

Regulation: EU MDD
Class: I self-certified

Regulation: EU MDD
Class: I s/m, IIa, IIb, III

Regulation: EU MDR
Class: I self-certified

Regulation: EU MDR
Class: I s/m, IIa, IIb, III

Regulation: EU IVDD
Class: Self-certified

Regulation: EU IVDD
Class: List A & B, Self-Test

Regulation: EU IVDR
Class: A (non-sterile)

Regulation: EU IVDR
Class: A (sterile), B, C, D

United Kingdom

Regulation: UKCA
Medical Devices

Regulation: UKCA
IVDs

EU Language Requirements Tool EU Registration Requirements Tool Significant Changes Assessment Tool EU Vigilance Requirements Tool Harmonized Standards & Common Specifications UKCA Marking Medical Devices Overview of GMDN, EMDN and CND Guide to Registering Devices in EUDAMED Additional Resources

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