Guidance – Clinical evaluation assessment report template
Posts tagged as “MDR”
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
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
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
Manufacturer incident report 2020 Manufacturer incident report for importing XML file with Adobe Professional 2020 Changelog file 2020
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories