Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year staggered implementation of the In Vitro [...]
Term Refinement in Literature Search
A literature search is a systematic search through existing data in an organized way to [...]
Self-Certification for CE Mark – An Overview
The gradual implementation of the European Medical Device Regulation (MDR, 2017/745) changed the game for [...]
Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been [...]
Post-Market Surveillance and Vigilance: MDR vs IVDR
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are [...]
Can Artificial Intelligence Technology Tame Literature Review?
When one tries to publish in an international journal these days, they inevitably encounter an [...]
IVDR: General Principles of Clinical Evidence for In Vitro Diagnostic Medical Devices (IVDs)
A year into the EU Medical Device Regulation (MDR 2017/745), it is safe to say [...]
The Relationships Between Literature Search and CER and PMS Vigilance, PMCF, and PSURs
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), [...]
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its [...]
World Health Day – April 7, 2022
Initiated by the World Health Organization and celebrated by all, each April 7 is recognized [...]