Guidance – Clinical evaluation assessment report template
Posts published in “European Commission”
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…
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…
M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization…
Notification of a Body in the framework of a technical harmonization directive – NB 2862 -Intertek Medical Notified Body AB