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EU MDR 6 min read

Understanding Global Regulatory Authorities in the Medical Device Industry

You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants…

By CiteMed Author

20 Nov 2025

EU MDR 5 min read

Using the IMDRF Classification to Apply Rule 11

The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification…

By CiteMed Author

20 Nov 2025

CER Writing 8 min read

Managing Clinical Evaluation Report (CER) and Literature Review Teams

Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to…

By CiteMed Author

20 Nov 2025

IVDR 6 min read

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 two sides of the same regulatory coin…

By CiteMed Author

20 Nov 2025

EU MDR 7 min read

Is MDR Compliance Expensive?

The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Updates of the MDCG 2019 9 Rev 1, SSCP, and Others

The term summary of safety and clinical performance has recently sent the medical manufacturing world into a buzz. The new MDCG 2019…

By CiteMed Author

20 Nov 2025

EU MDR 8 min read

12 EU MDR Guidance Documents You Need

EU MDR is undoubtedly a fantastic way of upgrading the medical device market quality, but the process is anything but easy. With…

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