MDCG outlines rules on EUDAMED registration for custom made and legacy devices

2024-02-26T16:46:14+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

The European Commission’s Medical Device Coordination Group (MDCG) last week published a new guidance with Q&A on obligations and related rules for the registration in EUDAMED of actors not subject to registration requirements under the Art. 31 Medical Device [...]

Turkey: New MDR and IVDR are applicable

2024-02-29T15:05:43+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

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 harmonized with European Union legislation, aims to improve [...]

EU: EUDAMED UDI/device registration and Certificates and Notified Bodies modules available by September 2021.

2023-04-21T09:20:12+00:00March 5th, 2021|Categories: Compliance, Europe|Tags: , , |

The European Commission announced the activation of the modules on UDI/device registration (second module) and on Certificates and Notified Bodies (third module) by September 2021. The first module on Actor registration is available since December 2020. EUDAMED will act as [...]

EU: MDCG issues guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

2023-03-31T13:15:38+00:00March 1st, 2021|Categories: Europe, Regulatory|Tags: , , |

The MDCG issued a new guidance "to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions [...]

EU: The European Commission issues a guidance on management of legacy devices in Eudamed

2023-03-31T13:14:00+00:00February 15th, 2021|Categories: Compliance, Europe, MDR|Tags: , , , |

The European Commission issued a new guidance explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database, expected to be fully rolled out by May 2022. "Legacy Devices are defined as Medical Devices, Active [...]

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