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 [...]

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 [...]

Handover of Expert Panels to EMA

2022-08-26T08:11:55+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: , , , , , , , , , , |

Handover of expert panels on medical devices and in vitro diagnostics to EMA 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 [...]

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 [...]

France: ANSM updates guidelines and forms for a scientific opinion for a medical device incorporating a medicinal substance

2022-10-06T14:31:20+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

France: ANSM updates Guidelines and Forms for a Scientific Opinion for a Medical Device incorporating a Medicinal Substance The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical [...]

Turkey: New MDR and IVDR are applicable

2022-10-06T14:49:12+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

Turkey: New MDR and IVDR are applicable The Medical Device Regulation (MDR) and the In vitro Diagnostic Medical Device Regulation (IVDR) were published in Turkish Official Gazette No. 31499 on 2 June 2021.  The Regulation, which is fully [...]

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

2022-10-06T14:50:59+00:00May 27th, 2021|Categories: Clinical Trial, Compliance, Europe, Switzerland|Tags: , , , , |

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

Meditrial MDR DIVERSITY Germany Clinical Trials

2021-05-06T14:41:06+00:00May 6th, 2021|Categories: Europe, MDR, Regulatory|Tags: , , , , |

The medical device regulation EU 2017/745 allows Member States some adjustments for local implementation. If you sponsor a trial in Germany, you must learn what are the new ordinances and guidelines for the implementation of the MDR. [...]

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