To be placed on the EU market, certain products without an intended medical purpose have…
New MDCG Guidance on content of the Investigator’s Brochure for clinical investigations under MDR
Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the…
MDCG Guidance on Clinical Investigation Plan
The Medical Devices Coordination Group (MDCG) released in March 2024 a new guidance on the…
MDR National implementation: Latvia
Latvia has implemented the Medical Devices Regulation 2017/745 (MDR) through its Medical Device Rule No 461 and…
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…
Clinical investigations under the MDR: New Revision of MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG…