The Medical Device Regulation (EU MDR) has introduced significant changes to the requirements for clinical evaluation of medical devices. This article will provide a comprehensive guide on incorporating the most relevant guidance from MDCG 2020-6, MDCG 2020-5, MDCG 2020-13, MEDDEV…
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If you’re still undecided on which Notified Body (NB) to choose or you’re in the early stages of development, Team-NB has just released this best practice guidance Guidance for the Submission of Technical Documentation under Annex II and III of…
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One of the critical steps in IVD development is the conduct of an IVDR clinical performance study to generate reliable and meaningful data to support regulatory approval and the device’s commercial success. In Europe, the in-vitro diagnostic regulation (EU IVDR)…
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MDx summarize the key updates to the MedTech Europe Regulatory eBook Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR) Version 3, published in February 2023, emphasizing the relevance of the CDx, clinical performance studies, similar/equivalent concepts, and…
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Since the implementation of the new EU MDR, there has been significant standardization in the processing of clinical investigation submissions throughout Europe. Each country, however, may have its own national provisions. This article is intended for clinical research experts who need…
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On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has become fully applicable with major consequences not only for manufacturers of IVDs but also for all diagnostic laboratories, particularly those that manufacture in-house…
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In recent years, there has been a dramatic increase in the use of digital health tools health in order to improve service quality, system effectiveness, and facility administration. The COVID-19 epidemic hastened this pattern. eHealth, often known as digital health,…
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Because the electronic system referenced to in Article 73 (Eudamed) will not be ready and completely functioning on the MDR’s effective date, this guideline covers the processes for safety reporting in clinical research in the absence of Eudamed. MDCG 2020-10…
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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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Roche announced on Friday that the Ventana PD-L1 (SP263) test has been CE marked for use in patients with lung cancer who are taking Regeneron’s Libtayo (cemiplimab). The goal of the test is to identify non-small cell lung cancer (NSCLC)…
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The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories). Article 100(4) of Regulation (EU) 2017/746 specifies the requirements that must be met by EU reference labs. In order to assure adherence to these standards,…
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Multiplex in vitro diagnostic (IVD) devices concurrently detect two or more targets/markers. Multiplex IVDs are sold as one device with their sole intended purpose. They may be intended to detect dozens of targets/markers, such as allergies or microorganisms. Due to…
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This scientific opinion reflects the views of independent experts (#MDR Article 106) on the #clinicalevaluation assessment report (CEAR) of the #notifiedbody. The advice is provided in the context of the clinical evaluation
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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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