Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)Search for available translations of the preceding link
EU – Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)
More from EuropeMore posts in Europe »
- EU – Guidance – Clinical evaluation assessment report template
- 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
- EU – New relocated website for medical devices in the EU Commission website
Be First to Comment