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Pharmacovigilance audits for Medical Device



  • Anoynomous
    10/01/2018 09:58
    Hello Can you please guide on conducting PV audits for Medical device studies Thanks
  • RQA GPvP Committee
    18/03/2018 17:23
    Dear Enquirer the EU/EEA countries have safety reporting legislation in place (technical term for AE is "incident"), see MEDDEV 2.12-1 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM. Both manufacturers and HCPs are required to report incidents. If you need details on reporting in the UK, please refer to the MHRA website https://www.gov.uk/topic/medicines-medical-devices-blood/medical-devices-regulation-safety If you need local guidance for other EU/EEA Health Authorities, we suggest using the search terms "incident medical device". We hope this response was helpful and apologise for the delay.
  • RQA GPvP Committee
    18/03/2018 18:55
    You may also find this booklet useful : Medical Devices Regulation Booklet (purchasable from RQA). We suggest to structure a device PV audit very similarly to a drug PV audit (e.g. QMS in place, staff training, incident reporting, management, signal trending processes, RA responsibilities/Registration of device/CE mark, update of Device Information/Marketing Brochures, safety reports from clinical studies, trackers to oversee compliance etc.) - but adjust the incident reporting requirements to the device legislation.
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