After a manufacturer has successfully completed the CE Marking process, they must sign a Declaration of Conformity. This is a legally binding document, in which the manufacturer asserts that they have met the minimum requirements of the applicable legislation.
Manufacturers of systems/procedure packs and custom-made devices must also draw up statements.
Below we provide the medical device & IVD Declaration of Conformity requirements in Europe*, the UK** and Switzerland.
* The European Single Market includes: all 27 EU member states, Iceland, Liechtenstein, Norway, Northern Ireland and Turkey.
** The United Kingdom is made up of four countries and all four have left the European Union: England, Scotland, Wales (together make ‘Great Britain’) and Northern Ireland (not part of Great Britain). The importance of defining Great Britain, is that those three countries will eventually require UKCA Marking, while Northern Ireland will continue to follow CE Marking. Due to a transition period, Great Britain currently allows manufacturers to market using their CE Marking.