The European Medicines Agency (EMA), in collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request…
Challenges for combined studies of medicines, IVDs, and devices
In the European Union, there are different regulatory requirements for clinical trials of medicinal products, clinical investigations of medical devices, and performance studies of IVDs.…
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 in performance studies of in-vitro diagnostic medical devices: MDCG 2024-4.…
Updated MDCG Guidance on clinical investigation
A clinical investigation can demonstrate a medical device’s safety and clinical performance. In December 2023, the Medical Device Coordination Group updated the guidance on clinical…
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 and document a clinical evaluation. As per Article 61(1) MDR,…
MDR QMS compliance: Necessary elements by 2024
Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One being to have set up a Quality Management System (QMS)…
Guidance on content and structure of the clinical investigation report summary
According to Article 77 of the Medical Devices Regulation (MDR), the sponsor of a clinical investigation has to submit a report of the clinical investigation.…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Devices Regulation (IVDR) 2017/746 are mainly the Act on the…
MDCG template for substantial modification of performance study
Performance evaluation data can derive from performance studies. Data generated in performance studies must be reliable and robust, as stated in the Regulation on IVD…