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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Due to the usage of shared software components, #cybersecurityvulnerabilities may affect a wide variety of apparently secure unconnected products from different manufacturers. Compounding the issue is the limited traceability of many common components in electronical #medicaldevices.
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The main purpose of this new guidance t is to create uniform expectations and understanding for Machine Learning-enabled Medical Devices (MLMD), improve patient safety, inspire innovation, and encourage access to breakthroughs in healthcare technology. Artificial Intelligence (#ai ) is an…
read moreDeep learning techniques using neural networks are used in medical devices to fulfill human capabilities in a variety of roles, such as: Disease prediction, detection, classification, and analysis.
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