Are You Over-Committing on Your EU MDR Post-Market Surveillance Plan?
Yes, most manufacturers do. They write PMCF studies, surveys, and monitoring frequencies into their PMS plan and CER that they don't have…
20 Nov 2025
Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the criteria for software qualification falling within the…
20 Nov 2025
CER Medical Writer Qualifications for EU MDR: 7 Essential Skills
A strong CER medical writer combines the right academic background, real regulatory experience, and precise technical writing, and meets the specific qualification…
20 Nov 2025
Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)
Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations…
20 Nov 2025
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for…
20 Nov 2025
Analyzing the Differences between CERs for MDR versus MDD
Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements.…
20 Nov 2025
IVDR: State-of-the-Art for In Vitro Diagnostic Medical Devices
With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements…
20 Nov 2025
Publishing Clinical Trials Results in Journals
Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness…
20 Nov 2025