MDR Article 62.2: The Role of Clinical Investigation Legal Representative
MEDTECH news November 25, 2023In the intricate world of medical device regulation, the European Union Medical Device Regulation (EU MDR) stands out as a... read more
Understanding the MDCG 2023-4 Guidance on Medical Device Software and Hardware Combinations
MEDTECH news October 20, 2023The world of medical device regulation is constantly evolving, with regulatory bodies introducing new guidances to keep up with the... read more
Understanding MDCG 2020-13: A Guide for Medical Device Manufacturers Preparing Clinical Evaluation Reports
MEDTECH news October 1, 2023The Medical Device Coordination Group (MDCG) plays a key role in setting the rules for medical devices in the European... read more
MDR Transition Period: Updated Q&A Document, Changes & Clarifications
MEDTECH news July 20, 2023The recent amendment of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) through Regulation (EU)... read more
How to Prepare Your Clinical Evaluation Plan Template in 5 Key Steps
MEDTECH news June 9, 2023In this article, we will delve into the intricacies of developing a robust Clinical Evaluation Plan using expert regulatory terminology,... read more
MDR Annex XVI: Regulating Medical Devices Without An Intended Medical Purpose
MEDTECH news June 2, 2023How are medical devices without an intended medical purpose regulated under the MDR Annex XVI? Continue reading to learn more.
Clinical Investigation Report for Medical Devices (2023/C 163/06): Preparing your CIR template
MEDTECH news May 10, 2023Following the end of a clinical investigation and irrespective of its outcome, the Regulation (EU) 2017/745 (MDR) and the International... read more
Impact of Spain’s Real Decreto 192/2023 on Clinical Investigations with Medical Devices
MEDTECH news April 22, 2023The field of medical devices is continually evolving, with new technologies and innovative products constantly being developed to improve patient... read more
EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions
MEDTECH news March 27, 2023In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of... read more
MDR Clinical Evaluation Report: The Roles of MEDDEV and MDCG Explained
MEDTECH news March 19, 2023The EU Medical Device Regulation has introduced significant changes to the requirements for clinical evaluation reports of medical devices. This... read more
What you need to know about new submission process for Clinical Investigations in Spain with the AEMPS
MEDTECH news February 13, 2023Since the implementation of the new EU MDR, there has been significant standardization in the processing of clinical investigation submissions... read more
Understanding MDCG 2020-10 Rev 1: Safety Reporting in Medical Device
MEDTECH news November 21, 2022In light of the forthcoming Medical Device Regulation (MDR) and the delay in the complete functionality of the electronic system... read more
MedTech Europe urges parliamentarians assess the challenges of the EU MDR 2017/745
MEDTECH news November 9, 2022Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to... read more
Clinical Evaluation Consultation Procedure (CECP)
MEDTECH news October 24, 2022This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical... read more
Position paper on cyber security
MEDTECH news October 13, 2022This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a... read more
Data produced by ‘Off-Label’ Device Use in accordance with EU Medical Device Regulation 2017/745
MEDTECH news October 13, 2022The Mirror-MDCG-Clinical Working group, which includes members of 11 NBs, created this position paper. It was distributed to all NBs... read more
New Team NB Position Paper | Best Practice for Submission of EU MDR Technical Documentation
MEDTECH news October 7, 2022To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the... read more
