EU Registration for Gloves: Examination Gloves fall under the Class I category of Medical devices intended for use in the medical field to protect users and patients from any possible cross-contamination and can be self-certified according to MDD 93/42/EEC.
All Medical Gloves 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:
- The manufacturer needs to Provide a Declaration of Conformity.
- Technical File ID
- Appointment of an European Representative
- Then EU registration