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
EU MDR Checklist : Compliance Essentials for Medical Device Manufacturers
The Medical Device Regulation (MDR) has been a regulatory framework since 2017. The MDR is designed to ensure that medical devices are…
20 Nov 2025
EU MDR Cybersecurity: Safeguarding Medical Devices in the Digital Age
In the fast-paced world of healthcare, there are always concerns regarding any new medical device. The concern about cybersecurity in medical devices…
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
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
Performance Plan Evaluation Under the EU IVDR 2017/746
Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in…
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
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