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 Coronavirus (COVID-19)More posts in Coronavirus (COVID-19) »
- EU – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- WHO – Critical items for clinical management of COVID-19
- EU – IMDRF Standards Checklist modified in scope of COVID-19
- EU – Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
- Free emergency regulatory service – Medical device registration in Brazil
More from COVID-19More posts in COVID-19 »
- EU – Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
- WHO – Critical items for clinical management of COVID-19
- EU – Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
- Free emergency regulatory service – Medical device registration in Brazil
- Serviço gratuito em caráter emergencial – Registro de dispositivos médicos no Brasil
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 – New relocated website for medical devices in the EU Commission website
More from Notified BodyMore posts in Notified Body »
- EU – New notified body designated under the MDR – NB 2862 -Intertek Medical Notified Body AB
- EU – Team-NB – Contacts to allow the check of the validity of the CE certificates
- EU – New notified body designated under the MDR – NB 0483 – MDC MEDICAL DEVICE CERTIFICATION GMBH
- EU – MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
- EU – MDCG 2020-5 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies
Be First to Comment