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…
20 Nov 2025
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…
20 Nov 2025
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…
20 Nov 2025
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…
20 Nov 2025
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…
20 Nov 2025
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…
20 Nov 2025
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)…
20 Nov 2025
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
For medical devices specifically, the 2022 Blue Guide doesn't add much that MDR and IVDR don't already cover in more detail. It updated the market surveillance…
20 Nov 2025