EUDAMED UDI/devices Updated Technical Documentation Module

2023-03-29T14:01:39+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|Tags: , , , , , , , , |

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 enumerations v2.7 MDR and IVDR introduce an EU device [...]

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

2023-03-29T14:01:43+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: , , , , , , |

EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]

EMA publishes Updated Version of Good Clinical Practice (GCP) Q&A

2023-03-29T14:01:51+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: , , , , , , , |

The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]

BVMed and SNITEM: Overcoming the MDR implementation bottleneck

2023-03-29T14:01:53+00:00March 24th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , , , , , |

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 joint statement, they call for three important points and [...]

Spain: AEPD Approves 1st Industry Code of Conduct to Enable Compliance with the GDPR

2023-03-29T14:02:09+00:00March 11th, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: , , , , , , , |

The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the General Data Protection Regulation (GDPR). The CoC has been promoted by Farmaindustria (the National Business Association of the Pharmaceutical Industry) and [...]

Swiss Single Registration Number – CHRN

2024-02-29T14:19:54+00:00March 8th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: , , , , , |

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 uniquely identify them. Meditrial successfully represents many [...]

Swiss Medical Device Database is Under Construction

2024-02-29T14:19:37+00:00March 4th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: , , , , , |

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 medical devices database will be similar to EUDAMED. [...]

Handover of Expert Panels to EMA

2023-03-29T14:04:04+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: , , , , , , , , , , |

Now, the European Medicines Agency has control of the Expert Panels on medical devices and in vitro diagnostic medical devices. On 1 March, the coordination Secretariat of the Commission’s expert panels on medical devices and in vitro diagnostic medical devices has been [...]

New Guidance: MDCG 2022-3 Verification by Notified Bodies

2023-03-29T14:06:17+00:00February 16th, 2022|Categories: Compliance, Europe, Regulatory|Tags: , , , , , , , , , |

In accordance with the conformity assessment procedures (described in Article 48 of IVDR), in addition to quality management system and technical documentation assessments, notified bodies are required to verify product batches of class D IVDs in line with Annexes [...]

MDCG updates the IVDR Implementation and Preparation Plan (EU)

2023-03-29T14:15:44+00:00February 7th, 2022|Categories: Compliance, Europe, Regulatory|Tags: , , , , , , , |

Joint implementation and preparedness plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) has been updated. Meditrial offers strategic-regulatory consulting services. We can help you to comply with the new regulation requirements. The document underlines that the [...]

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