EU MDR

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 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

EU MDR 7 min read

EU MDR: Combination Products – An Overview

We all know and love (ahem) the EU MDR (2017/745). And although it is defined as the EU Medical Device Regulation, it…

By CiteMed Author

20 Nov 2025

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 6 min read

Unpacking State-of-the-art: Why Does It Matter to My Medical Device Clinical Evaluation?

The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot…

By CiteMed Author

20 Nov 2025

EU MDR 7 min read

5 Major Concerns for Software As a Medical Device and AI Companies

Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices…

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