Imports such as PPEs and medical devices have to have the CE marking, except for pharmaceuticals. This marking indicates that:
- The manufacturer has checked that the product meets EU health, safety and environmental requirements.
- The product complies with EU legislation.
- The product can move freely within the European single market.
Before shipping medical goods from an EU country, ensure that the manufacturer or an authorised representative within the EEA has carried out a conformity assessment, drawn up the technical file, issued the EC declaration of conformity(DoC) and placed a CE mark on the product. The CE marking should be:
- In the standard recognisable form.
- Proportional to the standard version, in the case of enlarged or reduced product marking.
- At least 5mm.
- Placed onto the product, its data plate or accompanying document.