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), [...]

UK information session for Swiss medtech companies

2023-03-31T13:57:06+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 Monday, [...]

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 [...]

US: FDA launches the Digital Health Center of Excellence

2023-04-21T14:06:30+00:00October 20th, 2020|Categories: Clinical Trial, USA|Tags: , , , , |

The U.S. Food and Drug Administration recently launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). "The launch of the Digital Health Center of Excellence is an important step in furthering the agency’s [...]

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

2023-04-21T16:01:29+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) for [...]

EU: EMA supports digital health technologies in clinical trials

2020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: , , , , |

Digital health technologies  are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]

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