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Switzerland has officially implemented its adapted Ordinance on In Vitro Diagnostic Medical Devices (ODiV), effective January 1, 2025. This strategic...
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Under Directive 98/69/EC (IVDD), it was common practice for in vitro diagnostic medical devices to be placed on the European market under contractual...
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The EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of...
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In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European...
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Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...
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On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards...
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On 23 January 2024, the EU Commission published a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to...
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Vigilance reporting and postmarket surveillance of medical devices are among the many requirements documented in the EU MDR (2017/745) to ensure the...
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Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in...
