CE Marking30 Apr 2025 11:16
Stocksaint - how underwater are you here? the bitterness is appalling.
This is how a CE mark is obtained.
You do not fill a form out and say that's it we are now CE certified, there is a laid down procedure to follow, pharmaceutical Co's know the drill and that they will be heavily fined if they mess about with the EU and that all ancillary documentation has to be prepared and held on file for inspection.
How to obtain CE marking?
As the product's manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don't need a license to affix the CE marking to your product, however, before doing so, you must:
ensure conformity with all relevant EU-wide requirements
determine whether you can assess your product by yourself or if you have to involve a notified body
put together a technical dossier documenting conformity: find out about technical documentation
draft and sign an EU declaration of conformity
Once your product bears the CE marking — if the competent national authority requests — you must provide them with all the information and supporting documentation concerning CE marking.