In the European Union, there are different regulatory requirements for clinical trials of medicinal products,…
New MDCG guidance on safety reporting in IVDs performance study
The MDCG (Medical Device Coordination Group) just published a new guidance document on safety reporting…
What is the difference between a Clinical Study and Clinical Evaluation?
Under the Medical Devices Regulation 2017/745 (MDR), it is required for manufacturers to plan, conduct…