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_04792023-03-29T15:49:01+00:00December 1st, 2021|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Investigation, Clinical Trial, eumdr, Europe, European Union, MDCG, Medical Devices|
New guideline for Europe on trial changes has been published! MDCG 2021-28 - Substantial modification of clinical investigation under Medical Device Regulation. The sponsor of a clinical investigation is required to submit an application to the Member State in [...]
adminMTE_04792023-03-29T15:49:17+00:00November 4th, 2021|Categories: Various|Tags: 510K, BLA, denovo, Device Software, FDA, HDE, IDE, Medical Devices, PMA, SaMD, SiMD|
FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. This document is intended to cover: ▪️ firmware and other means for software-based control of medical [...]
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 [...]
Elena Trombettoni2024-02-02T10:49:34+00:00September 30th, 2021|Categories: Digital Health, FDA, Innovation, Software|Tags: 510K, eSubmission, FDA|
On September 28th, FDA published draft Guidance on the ''Electronic Submission Template for medical device 510k Submissions'', which will remain open for public consultation for 60 days. The Guidance introduces the electronic Submission Template and Resource tool eSTAR, which [...]
k.janecek2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: Clinical Trial, Complex Generic Drugs, DRUGS, EMA, Europe, European Union, FDA, Generic Drug, Hybrid Medicines, Innovation, medicines, PSA, Regulatory, USA|
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]
k.janecek2023-03-29T15:54:00+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: European Union, France, IVDR, MDR, notifiedbody, Western Europe|
The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical devices with ancillary medicinal substances. Scientific opinion must be requested for any new medical device or device-drug combination product, [...]
k.janecek2023-03-29T15:54:25+00:00July 19th, 2021|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: Clinical Trial, Europe, MHRA, UK|
The Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline the review process for clinical trials of medicinal products concerning the changes brought by Brexit. As of January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will [...]
k.janecek2024-02-26T16:46:14+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Eudamed, Europe, European Commission, European Union, MDCG, Regulatory|
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 [...]
k.janecek2024-02-29T15:05:43+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Eudamed, Europe, IVDR, MDR, Regulatory|
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 [...]
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