Proposed Classifications for Products without a Medical Intended Purpose
12 August 2022
MDCG Solutions: Notified Body Capacity & Manufacturer Readiness
26 August 2022Proposed Classifications for Products without a Medical Intended Purpose
12 August 2022MDCG Solutions: Notified Body Capacity & Manufacturer Readiness
26 August 2022
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
