Switzerland: New regulations applicable to medical devices as of 26 May 2021

2023-03-30T13:16:18+00:00May 27th, 2021|Categories: Clinical Trial, Compliance, Europe, Switzerland|Tags: , , , , |

Additional provisions have been adopted for the new Medical Device Regulation (MedDO) in Switzerland and enter into force on 26 May 2021. This action was taken to offset the negative consequences of the absence of the MRA update and [...]

Austria: medical device and IVD clinical trials submission process changes during transition to MDR

2023-03-31T09:12:27+00:00April 22nd, 2021|Categories: Clinical Trial, Europe, MDR|Tags: , , , , |

The Austrian Federal Office for Safety in Health Care (BASG) gave information on a new validation process during the transition to the MDR which will come into force in May 2021.Meditrial manages several studies in Austria and has direct connections [...]

International Council for Harmonisation (ICH) to issue revision of E6 (R2) Good Clinical Practice in the fall of 2021

2023-03-31T12:43:00+00:00March 31st, 2021|Categories: Clinical Trial, Compliance, Regulatory|Tags: , , , |

The International Council for Harmonisation (ICH) is working on the revision of E6 (R2) Good Clinical Practice, the guidace addressing GCP to provide a unified standard for the ICH region and to facilitate the mutual acceptance of clinical data. Meditrial [...]

Switzerland: New requirements and changes to authorization practice as of May 2021

2023-04-21T09:08:18+00:00March 24th, 2021|Categories: Clinical Trial, Europe, MDR, Switzerland|Tags: , , , |

Swissmedic has recently announced new regulations and requirements for the authorization of clinical trials in Switzerland. Meditrial and its team based in the Zug office manage several studies in Switzerland and has direct connections with Investigators, hospitals and local Ethics [...]

US: FDA provides examples on real world evidence to support marketing applications for medical devices

2023-04-21T09:12:50+00:00March 19th, 2021|Categories: Clinical Trial, USA|Tags: , , , , |

The FDA issued a document reporting examples of real world evidence (RWE) application to support marketing applications for medical devices. The document includes examples of RWE in several submission types: premarket notification 510(k) , De Novo, humanitarian device exemption (HDE), [...]

EU: EMA expands the use of remote source data verification in clinical trials

2023-03-31T13:12:41+00:00February 9th, 2021|Categories: Clinical Trial, Covid-19, Europe|Tags: , , , , , |

The European Commission and European Medicines Agency’s updated the guidance on managing clinical trials conducted during the COVID-19 pandemic by expanding the use and scope of remote source data verification (rSDV) in clinical trials. While previous versions of the guidance [...]

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

2023-04-21T13:04:51+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 clinical [...]

US: FDA introduces new Medical Device Development Tools for sponsors

2023-04-21T13:57:33+00:00October 22nd, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: , , , |

The FDA introduced a new Medical Device Development Tools (MDDT) for the investigation of medical devices. Through the MDDT program, the FDA defines tools that medical device sponsors can use in the development and evaluation of medical devices. The newly [...]

The International Medical Device Regulators Forum (IMDRF) issued an update on PMCF studies

2023-04-21T14:02:41+00:00October 21st, 2020|Categories: Clinical Trial, Europe, USA|Tags: , , , , |

The International Medical Device Regulators Forum (IMDRF) has issued an update proposal to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices. The proposal will be open for consultation untill 11 December 2020. The update includes advice on [...]

Go to Top