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The EC releases update on MDR-IVDR applications and certification

The European Commission’s (EC’s) Directorate-General for Health and Food Safety recently published a survey of notified bodies. This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In Vitro Diagnostic Regulation (IVDR).
European Commission Ec Directorate European Commission Food Safety Medical Devices Regulation Vitro Diagnostic Regulation Amending Regulation

Misleading CE Mark Documentation Certification Issued by Real Companies

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.
Global Fund Quality Assurance Real Companies Qa Team European Safety Federation Documentation Certification Issued Personal Protective Equipment

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