EUDAMED UDI/devices Updated Technical Documentation Module

2022-08-24T15:47:09+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|Tags: , , , , , , , , |

The EUDAMED UDI/devices module updated technical documentation is available The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device [...]

EMA’s advice on managing the impact of the war in Ukraine

2022-08-24T16:09:53+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: , , , , , , |

EMA’s advice to sponsors on managing the impact of the war in Ukraine on clinical trials EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war [...]

BVMed and SNITEM: Overcoming the MDR implementation bottleneck

2022-08-26T08:10:00+00:00March 24th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , , , , , |

BVMed and SNITEM: Overcoming the MDR implementation bottleneck The BVMed - German Medical Technology Association and SNITEM - the French National union of the medical technology industry are launching a Franco-German initiative for Medical Device Regulation. In a [...]

Swiss Single Registration Number – CHRN

2022-08-26T08:11:26+00:00March 8th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: , , , , , |

Swiss Single Registration Number - CHRN The Swiss Single Registration Number (CHRN) is assigned by Swissmedic based on the Medical Device Ordinance (MedDO; SR 812.213). It is assigned to Swiss manufacturers, authorised representatives or importers and serves to [...]

Swiss Medical Device Database is Under Construction

2022-08-26T08:11:38+00:00March 4th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: , , , , , |

Swiss Medical Device Database is Under Construction Swissmedic is in the process of developing a new database for registering economic operators and medical devices. Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the [...]

US: FDA guidance on CDRH Appeals Processes

2022-08-26T08:12:13+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , , , , , , |

US: FDA guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to [...]

New MDCG guidance 2022-4

2022-08-26T08:18:34+00:00February 17th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , , , , , |

New MDCG guidance 2022-4 The new MDCG guidance 2022-4 has been published. It clarifies how Notified Bodies shall perform surveillance of legacy devices during the transition period defined in MDR Article 120. The document provides guidance for surveillance [...]

FDA Finalizes Guidance for Premarket Pathways for Combination Products

2022-08-26T09:16:03+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: , , , , , , |

US: The FDA has finalized guidance on the use of premarket pathways for combination products The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the [...]

MDCG 2022-2 Guidance on general principles of clinical evidence for IVDs

2022-09-30T15:53:14+00:00January 28th, 2022|Categories: Regulatory|Tags: , , , , , |

MDCG 2022-2 Guidance on general principles of clinical evidence for in Vitro Diagnostic medical devices (IVDs) New #MDCG Guidance on general principles for #clinicalevidence and the continuous process of performance evaluation for #IVDs has been published The guidance describes the approach by which [...]

PREFER patient input to decision making under evaluation

2022-10-06T11:12:50+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: , , , , , , |

PREFER patient input to decision making under evaluation PREFER project has developed a framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical [...]

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