EU Review and assessment of market surveillance activities 2014-2016 – Medical devices sector By Marcelo Antunes on February 6, 2019 From document – Summary of EU Member States and EEA EFTA States’ assessment and review of the functioning of market surveillance activities according to article 18(6) of Regulation (EC) No 765/2008 for the period 2014-2016 Published in Europe and Post Market Surveillance PMS Marcelo Antunes More from EuropeMore posts in Europe »EU – Guidance – Clinical evaluation assessment report templateEU – Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)EU – Team NB position statement on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)UK – MHRA – Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDREU – Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devicesMore from Post Market SurveillanceMore posts in Post Market Surveillance »EU – MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodiesEU – MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodiesGrey literature and medical devicesCreating a post market surveillance (PMS) system for medical devices – Part 1Paper on open access – EU postmarket surveillance plans for medical devices
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