Manufacturers are required to perform the following tasks in relation to placing their products on the EU market:
- Design products that meet the essential health and safety requirements set out in the applicable EU directives;
- Draw up the required technical documentation
- Keep the technical documentation for the required period stated in the relevant directives;
- Undertake the correct conformity assessment procedures (e.g. module A and module B);
- Establish appropriate quality controls to ensure that all products produced in series production fulfil the requirements in the applicable directives;
- Take the necessary measures to resolve non-compliance issues in a product;
- Mark their products with their name, trademark and address;
- Ensure that instructions for use are provided with the products;
- Cooperate with the market surveillance authorities if enforcement action is taken against them.
- If located outside the EU, appoint an authorised representative.