Learn about the technical documentation manufacturers must prepare before placing a product on the EU market. This includes what technical documentation is and who is responsible for preparing it, ...
The EC Declaration of Conformity (DoC) is much more than a piece of paper being signed by the head of quality or regulatory affairs. It is a symbolic document that reflects a device manufacturer’s ...
On 16 March 2020, the European Commission published Recommendation (EU) 2020/403 of 13 March on conformity assessment and market surveillance procedures within the context of the COVID-19 threat. The ...