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 [...]
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 [...]
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_04792023-03-29T14:47:59+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 [...]
adminMTE_04792023-03-29T15:48:06+00:00January 3rd, 2022|Categories: Compliance, Regulatory|Tags: Compliance, eumdr, IVDR, Regulatory Affairs|
The European Commission has updated the Eudamed Actor Module FAQs. The document includes a revision of paragraph 4.6.4 relating to the publicly accessible contact details of Person Responsible for Regulatory Compliance (PRRC). Read more in the EC document. Contact Meditrial [...]
adminMTE_04792023-03-29T15:51:23+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: EMA, medicines, MedTech, Patient Experience, Pharma, Regulatory Affairs, Technology|
PREFER project has developed a framework with points to consider when selecting methods for industry, regulators and health technology assessment bodies for how to use patient preferences as input in medical product decision making. European Medicines Agency and EUnetHTA - European Network [...]
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