EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions

EU Q&A Guide: Amendments to MDR and IVDR Transitional Provisions

MEDTECH news March 27, 2023

In our latest article, MDx offers a comprehensive summary of the European Commission’s Q&A document, focusing on the implementation of Regulation (EU) 2023/607, which amends transitional provisions for specific medical devices and in vitro diagnostic devices under Regulations (EU) 2017/745... read more

Clinical Evaluation Consultation Procedure (CECP)

Clinical Evaluation Consultation Procedure (CECP)

MEDTECH news October 24, 2022

This scientific opinion represents independent specialists’ opinions (MDR Article 106) on the notified body’s Clinical Evaluation Assessment Report (CEAR). Clinical Evaluation Consultation Process (CECP) is an extra aspect of conformity assessment by recognized organizations for high-risk devices (MDR Article 54... read more

Position paper on cyber security

Position paper on cyber security

MEDTECH news October 13, 2022

This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a high level document. Improvements in patient care are more significant than new market potential for the manufacturer as a result... read more