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Hi Anon I am sending the list of language requirements -MDR for your information The below information is provided based on the information available to the Commission services following a consultation of the Medical Device Coordination Group (MDCG) in October 2023. The Commission services ...

Hi all I agree with description with both colleagues. Maybe it's a miscommunication about the claim "the need to address bacterial endotoxins is required for all devices" From my point of view as a former CE auditor, if the auditor (I guess bsi) has detected certain findings from the audit (eg observations, ...

Hi all From my point of view, after the expiry of the existing EC certificate, the product that is given on the certificate should not be launched/ putt on the market after the date of the certificate. The manufacturer should report this change to its notified bodyand competent authority in the state ...

Hi all I agree with Richard what he says below. It is only necessary to know that this change (repackaging) is needed to consult / report to your notified body as well.. ------------------------------ Evangelos Tavandzis Lead Auditor, Consultant Praha Czech Republic ----------------------------- ...