EU MDR 10 min read

Your Medical Device Got CE Marked – Now What?

Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes…

By CiteMed Author

20 Nov 2025

EU MDR 13 min read

Navigating Medical Device Safety, Regulation, and Adverse Europe

Adverse Events in Europe The landscape of medical device safety in Europe is significantly influenced by the occurrence and management of adverse…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Switzerland’s Medical Device Regulation and the EU Regulations

The medical device industry is thriving globally. Not only in European Union countries, but the influence is also seen in neighboring countries…

By CiteMed Author

20 Nov 2025

EU MDR PMS and PMCF 6 min read

Market Surveillance of Medical Devices Under the EU MDR

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed…

By CiteMed Author

20 Nov 2025

EU MDR PMS and PMCF 5 min read

Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices

In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force.…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?

MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR)…

By CiteMed Author

20 Nov 2025