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Classification of IVD under the IVDR
In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a
What You Need to Know About the New ISO 14155:2020 Standard
New requirements in the ISO 14155 standard for Medical Device Clinical Investigations The ISO 14155:2020 (Clinical investigation of medical devices
European Medical Device Law
Navigating the legal framework for placing Medical Devices (MD) and In Vitro Diagnostic medical devices (IVDs) on the EU market can seem complicated
What are the MEDDEV Guidance Documents?
MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European
What is a clinical trial?
A clinical trial is any research conducted in humans evaluating the performance and safety of an investigational product. James Lind conducted the
The 4 Pillars of Successful CER Writing
Writing an exemplar Clinical Evaluation Report (CER) requires skills that blend scientific, medical/clinical, regulatory, and technical competences. A
What is a Medical Device?
A medical device is any device intended to be used for medicinal purposes by physical actions. MDR defines Medical device as: ‘’ any
What is MedTech?
MedTech, or medical technology, is every product, service, or solution using medical technology to improve people’s health by preventing, diagnosing,
List of Member States’ Competent Authorities for Medical Devices
The competent authorities are responsible for transposing the requirements of European regulations into national legislation. The competent
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