EU Registration for Face Masks: face masks usually fall into two categories – Medical Face Masks and Respirators. Medical Masks intended to stop cross contamination between user and patient fall under MDD directives. Respiratory Masks intended to prevent inhaling dust, vapors etc. fall under PPE Directives. Depending on mask type relevant EU regulations/directives apply.
All Medical Face Masks and PPE Masks must comply with the relevant regulations before they are granted a CE marking. They need to be able to pass relevant performance tests. The steps for registration:
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- The manufacturer needs to Provide a Declaration of Conformity.
- Technical File ID
- Appointment of an European Representative
- Then EU registration