k.janecek2023-03-29T14:05:32+00:00February 17th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: Compliance, European Commission, European Union, IVD, IVDR, MDCG, MDR, MedTech, Regulatory, Regulatory Affairs|
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 [...]
k.janecek2023-03-29T14:06:17+00:00February 16th, 2022|Categories: Compliance, Europe, Regulatory|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, MDCG, Medical Devices, Regulatory, Regulatory Affairs|
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 [...]
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.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, [...]
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 [...]
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