adminMTE_04792020-07-07T07:57:08+00:00July 7th, 2020|Categories: Compliance, Covid-19, Europe|Tags: Covid-19, Europe, European Commission|
The European Commission launched the JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database. The objective of this database is to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices [...]
adminMTE_04792024-02-26T16:44:18+00:00June 12th, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Europe, European Commission, MDCG, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) released guidance about the process for transitioning CE certificates for devices carrying ancillary substance which could be considered a medicinal product and those incorporating animal tissues to the MDR. Ancillary substances [...]
k.janecek2024-02-07T15:50:33+00:00June 9th, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, Regulatory|
The European Commission updated its “rolling plan” for adopting implementing acts and other actions/initiatives ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The update follows the delay of implementation of the MDR by one [...]
adminMTE_04792024-02-29T14:38:43+00:00May 22nd, 2020|Categories: Compliance, Covid-19, Europe, MDR, Regulatory|Tags: Clinical Trial, Covid-19, Europe, European Commission, Regulatory|
The European Commission issued new regulations simplifying the process for renewing notified body designations prior to the postponed deadline for application of the Medical Devices Regulations (MDR), 26 May 2021. Moreover, the Commission issued guidelines explaining the process and requirements [...]
adminMTE_04792024-02-29T14:36:51+00:00May 14th, 2020|Categories: Compliance, Covid-19, Europe, Software|Tags: Covid-19, Digital Health, Europe, European Commission|
The European Commission (EC) shared a Q&A on safe and efficient use of mobile tracing apps across the EU. What is a contact tracing and warning app? A contact tracing and warning app is voluntarily installed and used to [...]
k.janecek2024-02-02T11:41:53+00:00April 29th, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: Clinical Trial, Covid-19, EMA, Europe, European Commission, Regulatory|
European Medicines Agency (EMA) updated the guidance on the management of clinical trials during COVID-19 pandemic. Version 3 published on 28 April 2020 provides additional clarification on: the distribution of medicines to trial participants. This takes into account social-distancing measures [...]
k.janecek2024-02-29T09:43:48+00:00April 28th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR, Regulatory|Tags: Covid-19, Europe, European Commission, European Union, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for post market clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators. Equivalence [...]
k.janecek2024-02-07T15:52:28+00:00April 24th, 2020|Categories: Covid-19, Europe, MDR, Regulatory|Tags: Europe, European Commission, MDR|
Medical devices can be sold for another year under the current regulatory framework based on the EU Medical Device Directive (93/42/EEC). The European Commission welcomes the adoption by the European Parliament and the Council of the proposal to postpone [...]
adminMTE_04792024-02-02T12:16:25+00:00April 17th, 2020|Categories: Covid-19, Europe|Tags: Covid-19, Digital Health, Europe, European Commission, European Union|
The EC and the EU Members States issued a toolbox for the use of mobile applications for contact tracing and alerting during the coronavirus pandemic. The toolbox is accompanied by guidance on data protection for such mobile app “Contact [...]
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