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17/11/1985
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The European Union officially released the In Vitro Diagnostic Regulation (IVDR) in 2017, replacing the previous In Vitro Diagnostic Directive (IVDD). The IVDR came into effect in May 2022, but the European Parliament approved a proposal in April 2024 to extend the transition period, with the longest extension possible until 2029. https://www.proregulations.com/eu-in-vitro-diagnostic-regulation-ivdr-registration.htmlThe European Union officially released the In Vitro Diagnostic Regulation (IVDR) in 2017, replacing the previous In Vitro Diagnostic Directive (IVDD). The IVDR came into effect in May 2022, but the European Parliament approved a proposal in April 2024 to extend the transition period, with the longest extension possible until 2029. https://www.proregulations.com/eu-in-vitro-diagnostic-regulation-ivdr-registration.html0 Commentarii 0 Distribuiri 118 Views
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510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. https://www.proregulations.com/u-s-medical-device-510k-premarket-notification.html510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. https://www.proregulations.com/u-s-medical-device-510k-premarket-notification.html0 Commentarii 0 Distribuiri 181 Views
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