Tag: Medical devices

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EU Commission Measures during Covid-19 Pandemic and Regulatory Deadlines

30 April, 2020 Kaeltia Biocide, Plant Health, Public Health, Regulation A.I. renewal, Medical devices, Regulation 1107/2009, Regulation 528/2012
EU Commission Measures during Covid-19 Pandemic and Regulatory Deadlines

Please see below the latest measures taken by the EU Commission related to regulatory issues during Covid-19 Pandemic: The Commission has published guidance to ensure that clinical trials can continue taking place in the EU during the COVID-19 pandemic. The Commission welcomes the adoption by the European Parliament and the Council of the proposal to […]

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Medical devices: new regulatory framework

29 December, 2016 Kaeltia Public Health, Regulation Medical devices
Medical devices: new regulatory framework

The new Medical Devices framework consists of two Regulations: In Vitro Diagnostic Medical Device Regulation (IVDMDR) which will replace the current Council Directive 98/79 on In Vitro Diagnostic Medical Devices Medical Device Regulation (MDR) which will replace the following current Directives: Council Directive 93/42/EEC on Medical Devices Council Directive 90/385/EEC on Active Implantable Medical Devices […]

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