Article 77(5) Medical Devices Regulation requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation...
As set out in the interim report of the pilot: In 2020, the joint Big Data Task Force of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published ten priority recommendations...
Diversity Action Plans are intended to increase enrollment of participants who are members of historically underrepresented populations in clinical studies to help improve the strength and generalizability of the evidence for the intended use population....
This guidance is dedicated to the definition, classification, and assessment of the certainty of results of studies leading to the statistical analysis of data considered as originating from or part of a single study (i.e.,...
The EMA published the meeting report, the presentation materials and the video recording of the the EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma held the 12 January 2024. The European Medicines...
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Read the update from Medicines and Healthcare products Regulatory Agency published on 2 July 2024.
This document provides guidance to manufacturers and notified bodies on the clinical evaluation pursuant to the Medical Devices Regulation (MDR) of medical devices and accessories for medical devices that qualify as ‘orphan devices’ and medical...
The purpose of this consultation is the provision of independent scientific opinions by expert panels designated pursuant to Commission Implementing Decision (EU) 2019/13962 on the notified body’s clinical evaluation assessment report (CEAR) based on the...
This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed on...
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Read the news from Medicines and Healthcare products Regulatory Agency published on 16 January 2024.
