Tag: Clinical Evaluation

MDR, News in Brief

bsi white paper on clinical evaluations

December 15, 2021
MDR, News in Brief

bsi article on clinical evaluation requirements under the MDR

August 8, 2021
Important Notice, MDR

Sufficient clinical evidence under the MDR for class I legacy devices

November 3, 2020
Important Notice

EU guidance on Notified Body clinical evaluation assessment reports

July 24, 2020
Important Notice, MDR

Clinical evaluation and equivalence – using literature under the MDR

June 5, 2020
Important Notice, MDR

Urgently Required MDR Guidance Documents for Clinical Evaluations and PMCF Published

April 29, 2020
Important Notice, IVDR, MDR

MDR and IVDR guidance updates

April 9, 2020
News in Brief

New Checklist for Clinical Evaluations Available

August 19, 2019
News in Brief

Updated Clinical Evaluation Guidance on Comparability

April 8, 2019
News in Brief

Why is a Clinical Evaluation so Important?

December 11, 2018