Guidance – Clinical evaluation assessment report template
Posts published in “Europe”
Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices)Search for available translations of the preceding link
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…
Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices
It’s under DG Health now – Medical Devices – Sector
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also…
Effective field safety notices (FSNs): guidance for manufacturers of medical devices
COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and…