3-D printing (additive manufacturing) of medical devices
Posts published in July 2020
Guidance – Clinical evaluation assessment report template
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
Actual and potential harm caused by medical software
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…
First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review MHRA response statement to IMMDS Review report publication