EU MDR

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

EU MDR IVDR 6 min read

How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR

A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the…

By CiteMed Author

20 Nov 2025

EU MDR 11 min read

Literature Reviews for EU MDR

Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing the literature is…

By CiteMed Author

20 Nov 2025

EU MDR 8 min read

Breaking Down EU MDR Implementation for Class 1 Medical Devices

Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class…

By CiteMed Author

20 Nov 2025

EU MDR 10 min read

Performing Effective Literature Search – For EU MDR and Other Regions

For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One…

By CiteMed Author

20 Nov 2025