UK: MHRA published guidance on clinical trial risk assessment, oversight and monitoring activities.

2024-02-29T16:24:13+00:00February 4th, 2022|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: , , , , , , |

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents. It aims to assist sponsors and those conducting trials on implementing adequate oversight and monitoring [...]

MHRA announces combined review of clinical trials for medicinal products

2023-03-29T15:54:25+00:00July 19th, 2021|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: , , , |

The Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline the review process for clinical trials of medicinal products concerning the changes brought by Brexit. As of January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will [...]

UK: MHRA updates guidance on virtual manufacturing of medical devices

2024-02-29T16:27:55+00:00February 4th, 2021|Categories: UK|Tags: , , , , |

The UK MHRA has updated a guidance on virtual manufacturing of medical devices. "A virtual manufacturer is an organisation that fully sources its own named product from another company [...] which has designed and manufactured an identical UKCA/CE/CE UKNI [...]

Post-BREXIT EU relations with the United Kingdom and impact on medical devices

2024-02-29T14:05:00+00:00January 4th, 2021|Categories: Compliance, Regulatory, UK|Tags: , |

As of 1 January, 2021 new relationships between the UK and the EU came into force. Among others this will impact the medtech industry with new requirements for market access and device registration. Meditrial offers market access and regulatory [...]

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 [...]

UK information session for Swiss medtech companies

2024-02-29T15:06:23+00:00November 13th, 2020|Categories: Regulatory, Switzerland, UK|Tags: , , , , |

The UK’s Department for International Trade in Switzerland announced a virtual information session specially for Swiss medtech and medical device companies, to give an update on latest policy developments and regulatory guidance. The event will take place online on [...]

UK: MHRA supports generating RWE in clinical trials through digital solutions

2024-02-29T16:25:13+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: , , , , |

UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions. MHRA exaplained that real-world data source in [...]

UK: MHRA plans to restart on-site inspections as of September 2020

2024-02-29T16:01:48+00:00August 14th, 2020|Categories: Clinical Trial, Covid-19, UK|Tags: , , , |

MHRA issued a guidance including the plan to resume on-site inspections next September and scale up to full on-site inspection program in October 2020. Onsite inspections in the UK halted in March due to the COVID-19 pandemic. If you [...]

UK: Changes to amendment submission to HRA/MREC

2024-02-29T15:14:45+00:00July 8th, 2020|Categories: Clinical Trial, Europe, UK|Tags: , , |

On 2 June 2020 changes were introduced in the Integrated Research Application System (IRAS) to the way amendments are notified to Research Ethics Committees and NHS/HSC in the UK: Project-based research should now prepare amendments using the Amendment Tool. Amendments [...]

UK: MHRA provides regulatory guidance on software used in the diagnosis, treatment and management of  COVID-19 patients

2024-02-29T16:23:25+00:00June 8th, 2020|Categories: Covid-19, Regulatory, UK|Tags: , , |

MHRA provided advice for manufacturers, members of the public and professional users of software or apps being used during the COVID-19 pandemic. Standalone software and apps that meet the definition of a medical device are required to be CE [...]

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