EU: European Union and Commission launch EU4Health funding program to boost healthcare digitalization and make devices more accessible

2023-03-31T13:23:04+00:00March 30th, 2021|Categories: Europe, Innovation|Tags: , , , |

As COVID-19 keeps surging throughout many of the European countries, the EU and EU Commission launched EU4Health, the €5.1 billion funding program targeting EU countries, health organisations and NGOs. Aim of the program is to strengthen the resilience of post [...]

UK: Get ready for UK market access and the new UKCA requirements

2023-03-31T16:32:08+00:00December 1st, 2020|Categories: Compliance, Regulatory, UK|Tags: , , |

The UKCA (UK Conformity Assessed) marking will be the UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland) as of January 1st 2021. Meditrial offers market access and [...]

Netherlands: Notifications of clinical investigations with medical devices to CCMO as of the 1st of October

2024-02-29T13:56:00+00:00October 9th, 2020|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: , , , |

From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). The Committee will take over the tasks of the Healthcare and Youth Inspectorate (IGJ) [...]

EU: Common specifications for reprocessing single-use devices set by the European Commission

2020-08-24T08:31:47+00:00August 24th, 2020|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , |

On August 19th, 2020 the European Commission implemented regulation as regard common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under the MDR, single-use devices may be reprocessed where permitted by national law. Reach [...]

MDCG publishes new guidances on Equivalence, Legacy devices, PMCF and Ventilators

2024-02-29T09:43:48+00:00April 28th, 2020|Categories: Clinical Trial, Covid-19, Europe, MDR, Regulatory|Tags: , , , , |

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 [...]

EU Members States and European Commission introduce mobile apps to gradually loosen confinement

2024-02-02T12:16:25+00:00April 17th, 2020|Categories: Covid-19, Europe|Tags: , , , , |

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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