New MDCG guidance 2022-4

2023-03-29T14:05:32+00:00February 17th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , , , , , |

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 activities according to four different [...]

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 [...]

US: The FDA has finalized guidance on the use of premarket pathways for combination products

2024-02-29T17:17:22+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|

The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the FDA and sponsors, and recommendations on how to determine the types of premarket submissions for a [...]

FDA Finalizes Guidance for Premarket Pathways for Combination Products

2023-03-29T14:06:37+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: , , , , , , |

The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the FDA and sponsors, and recommendations on how to determine the types of premarket submissions for a [...]

The MDCG updates the IVDR Implementation and Preparation Plan (EU) 2017/746

2024-02-29T14:43:15+00:00February 7th, 2022|Categories: Compliance, Europe, Regulatory|

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 [...]

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 [...]

PIC/S revises GMP guide to reflect new EU Clinical Trials Regulation

2023-03-29T14:25:58+00:00February 2nd, 2022|Categories: Compliance, Europe, Regulatory|Tags: , , |

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised its good manufacturing practice (GMP) guide to reflect the new EU clinical trials regulation (CTR), which took effect on January 31, 2022. Investigational medicinal products shall be manufactured by applying manufacturing practices [...]

New FDA guidance: Good ANDA Submission Practices

2023-03-29T14:26:12+00:00February 1st, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: , , , |

The US Food and Drug Administration (FDA) has published a new guidance for industry: Good ANDA Submission Practices. "This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, [...]

MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

2023-03-29T14:47:07+00:00January 12th, 2022|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: , , , |

The MDCG 2022-1 Notice has been published It is addressed to manufacturers of SARS-CoV-2 IVDs based in a third country and who place or intend to place their in vitro diagnostics on the EU market. It highlights a number of common issues [...]

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

2023-03-29T14:47:59+00:00January 3rd, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: , , , , , |

European Medicines Agency published a new Guideline on the reporting of Serious Breaches, that will come into effect on January 31, 2022. Find out: ✔ how to report serious breach ✔ responsibilities of the different parties involved in the notification ✔ examples [...]

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