Sourcing & Management of Health Products - Updates

Misleading CE Mark Documentation Certification Issued by Real Companies

10 March 2022

Following an LFA verification of a Recipient’s procurement, the QA Team would like to bring to the attention of the procurement community that certain Personal Protective Equipment (PPE) products and medical devices, and related documents, prominently display the CE mark logo whereas the products have not been verified as meeting European procedures. Such CE marks have no legal value and cannot be used as conclusion of conformity assessment. The way the documents are presented, bearing the CE mark logo, is instilling in those who receive them the idea that the product is compliant with current European legislation (Medical Device or Personal Protective Equipment). In fine print it is sometimes specified that they do not confer a CE mark.

It seems that the majority of these documents carries the name of the company: Ente Certificazione Macchine (ECM) who is an official notified body for radio equipment and certain medical devices but not for PPE. The same company officially stated to the European Safety Federation (ESF), which is a non-for-profit trade association of PPE suppliers, that any activity performed in regard to the PPE directive has been a voluntary review of technical documentation and cannot substitute a CE certification in any way.

Therefore the attention of procurement and Quality Assurance specialists is called to not confer to such documentation any proof of any kind regarding compliance with Global Fund Quality Assurance requirementsdownload in English | Español | Français ] .