k.janecek2022-08-24T15:47:09+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, MDR, Medical Devices, MedTech|
The EUDAMED UDI/devices module updated technical documentation is available The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device [...]
k.janecek2022-08-25T10:19:19+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: Clinical Trial, Compliance, EMA, Europe, European Union, medicines, Regulatory, Regulatory Affairs|
EMA has published an updated version of its good clinical practice Q&A The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of [...]
k.janecek2022-08-26T08:10:00+00:00March 24th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: Compliance, eumdr, Europe, European Commission, European Union, MDR, Medical Devices, MedTech, Regulatory, Regulatory Affairs|
BVMed and SNITEM: Overcoming the MDR implementation bottleneck The BVMed - German Medical Technology Association and SNITEM - the French National union of the medical technology industry are launching a Franco-German initiative for Medical Device Regulation. In a [...]
k.janecek2022-08-26T08:18:34+00:00February 17th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: Compliance, European Commission, European Union, IVD, IVDR, MDCG, MDR, MedTech, Regulatory, Regulatory Affairs|
New MDCG guidance 2022-4 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 [...]
k.janecek2022-08-26T08:46:44+00:00February 16th, 2022|Categories: Compliance, Europe, Regulatory|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, MDCG, Medical Devices, Regulatory, Regulatory Affairs|
New guidance: MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies 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 [...]
k.janecek2022-09-30T15:22:50+00:00February 7th, 2022|Categories: Compliance, Europe, Regulatory|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, Regulatory, Regulatory Affairs|
The MDCG updates the IVDR Implementation and Preparation Plan (EU) 2017/746 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 [...]
adminMTE_04792022-10-06T09:26:41+00:00December 1st, 2021|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Investigation, Clinical Trial, eumdr, Europe, European Union, MDCG, Medical Devices|
Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2) 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 [...]
k.janecek2022-10-06T12:45:59+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|
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products 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 [...]
k.janecek2022-10-06T14:31:20+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: European Union, France, IVDR, MDR, notifiedbody, Western Europe|
France: ANSM updates Guidelines and Forms for a Scientific Opinion for a Medical Device incorporating a Medicinal Substance The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical [...]
k.janecek2022-10-06T14:46:01+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Eudamed, Europe, European Commission, European Union, MDCG, Regulatory|
MDCG outlines rules on EUDAMED registration for custom made and legacy devices 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 [...]
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