Literature Review 7 min read

A literature search is a systematic search through existing data in an organized way to determine an extensive range of quality references…

By CiteMed Author

20 Nov 2025

EU MDR 5 min read

What Is a Legacy Device, and What Do Manufacturers Need to Know About It?

The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions…

By CiteMed Author

20 Nov 2025

Systematic Review 11 min read

Systematic Literature Reviews

The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. In May 2021,…

By CiteMed Author

20 Nov 2025

EU MDR Comparing CER and PSUR for Clinical Evaluation & Safety

CER Writing 6 min read

Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)

Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The…

By CiteMed Author

20 Nov 2025

EU MDR 11 min read

EU IVDR Regulation: A Brief

IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The…

By CiteMed Author

20 Nov 2025

Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance

PMS and PMCF 9 min read

Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR

Under the European Medical Device Regulation (EU MDR 2017/745), manufacturers are required to conduct post-market clinical follow-up (PMCF) as part of their…

By CiteMed Author

20 Nov 2025