MedTech Compliance Articles
Expert guides on EU MDR, Clinical Evaluation, and Literature Review strategies.
CiteMed | EU MDR & Clinical Evaluation Insights
In-depth articles and resources on EU MDR, IVDR, and clinical evaluation for regulatory affairs professionals.
Categories
Latest Articles
Navigating Medical Device Safety, Regulation, and Adverse Europe
Adverse Events in Europe The landscape of medical device [...]
Updating the Literature Review and Literature Search Protocol
Getting the long-awaited CE mark is certainly something to [...]
Switzerland’s Medical Device Regulation and the EU Regulations
The medical device industry is thriving globally. Not only [...]
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
In July 2021, Regulation (EU) 2019/1020 on market surveillance [...]
Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?
MDCG’s Guidance document, released in July 2020, introduces and [...]
Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year [...]