Market surveillance of personal protective equipment

The PPE Regulation (EU) 2016/425 states that market surveillance authorities should have easy access to the EU declaration of conformity. To meet this requirement, manufacturers must ensure that the PPE is accompanied by a copy of the declaration of conformity or the internet address (URL) to which the EU declaration of conformity can be accessed.

 

There is also a procedure described to apply on a national level for PPE presenting a risk.

As one of the following cases occurs there is a formal non-compliance.

 

  1. the CE mark is applied contrary to Article 30 of Regulation (EC) 765/2008 or Article 17 of the PPE Regulation (EU) 2016/425;
  2. the CE mark has not been affixed;
  3. the identification number of the notified body (NoBo) which is in charge of the production control phase (Module C2 or D) is not applied or applied in breach of Article 17;
  4. the EU declaration of conformity has not been drawn or not drawn up correctly;
  5. the technical documentation is not available or not complete;
  6. the name, registered trade name or registered brand and the postal address of the manufacturer or importer is missing on the PPE or its packaging;
  7. any other administrative regulation which applies to the manufacturer or importer is not fullfilled.