Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to treat patients. This dangerous disease affects both new and old devices. The EU institutions must take urgent and decisive action.…
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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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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 moreThe 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.
Team-NB produced a Position Paper on measures for class D IVD in the absence of EU Reference Laboratories as a result of the IVD working group’s efforts. During the General Assembly meeting, a sizable majority of the members approved the…
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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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The Mirror-MDCG-Clinical Working group, which includes members of 11 NBs, created this position paper. It was distributed to all NBs via CIRCABC. It has received approval from the Team-NB general assembly. Off-label usage is addressed in the Medical Device Regulation…
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To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practice guidance documents that each Team NB notified body member had submitted. They then prepared this best practice guidance…
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MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.
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