MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
EU – MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
More from EuropeMore posts in Europe »
- EU – Guidance – Clinical evaluation assessment report template
- EU – 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 MDR
- EU – Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
More from MDCG - Medical Devices Coordination GroupMore posts in MDCG - Medical Devices Coordination Group »
- EU – MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
- EU – MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
- EU – Ongoing Guidance development within MDCG Subgroups
- EU – MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
- EU – MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
Be First to Comment