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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
What is the status of the COVID-19 rapid tests in the EU/EEA?
In-vitro diagnostic tests for detecting the coronavirus is an essential tool in slowing the
Humanitarian Exemption and Emergency Approval Scenarios
United States - European Union Exceptional regulatory situations have been allowed recently due to the coronavirus pandemic. Exceptional
List of Notified Bodies under MDR (EU) 2017/745 on Medical Devices
A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity
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