Elena Trombettoni2024-02-29T17:17:22+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 [...]
k.janecek2023-03-29T14:06:37+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: 510K, Compliance, FDA, medicines, MedTech, Regulatory Affairs, 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 [...]
Elena Trombettoni2024-02-29T14:43:15+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 [...]
k.janecek2023-03-29T14:15:44+00:00February 7th, 2022|Categories: Compliance, Europe, Regulatory|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, Regulatory, Regulatory Affairs|
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 [...]
k.janecek2024-02-29T16:24:13+00:00February 4th, 2022|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: Clinical Trial, Compliance, Europe, MHRA, Regulatory, Regulatory Affairs, UK|
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents. It aims to assist sponsors and those conducting trials on implementing adequate oversight and monitoring [...]
k.janecek2023-03-29T14:25:58+00:00February 2nd, 2022|Categories: Compliance, Europe, Regulatory|Tags: EMA, Europe, Regulatory|
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 [...]
k.janecek2023-03-29T14:26:12+00:00February 1st, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
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, [...]
adminMTE_04792023-03-29T14:46:55+00:00January 28th, 2022|Categories: Uncategorized|Tags: Conformity Assessment, EU IVDR, Invitro Diagnostics, MedTech, Post Market Surveillance, Regulatory Affairs|
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 collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing [...]
adminMTE_04792023-03-29T14:47:07+00:00January 12th, 2022|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: Compliance, Covid-19, Europe, Invitro diagnostic devices|
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 [...]
adminMTE_04792023-03-29T14:47:59+00:00January 3rd, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: Compliance, ctis, EMA, Regulatory Affairs, regulatorycompliance, SAFETY|
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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