The future of diagnostics

The future of diagnostics

MEDTECH NEWS November 2, 2022

The future of diagnostics Technology driven personalised and preventative healthcare in Europe Although there has been a significant growth in recent years in the understanding of the crucial role that diagnostics play in European healthcare, diagnostics firms still confront numerous…

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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…

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Making use of directive conformity evaluations to demonstrate compliance with MDR standards

MEDTECH NEWS 13 October, 2022

The members present at the general assembly expressed their overall support for the draft position document. When the paper is finished and the Commission and NBO’s feedback has been taken into consideration, a vote will be held to approve it.

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…

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