e.alvarado2022-08-04T14:21:10+00:00June 28th, 2022|Categories: Meditrial|Tags: Clinical Trial, Devices, GCP, Good Clinical Practice, IN-VITRO, IVD, IVDR, Medical Devices|
Atty. Alessia Nuciari, director of compliance Meditrial. The in vitro diagnostics industry has undergone a substantial transformation. IVDR Regulation 746/2017, published in May 2017 and applied from May 26, 2022, introduced major changes in the industry. The main [...]
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.janecek2022-08-26T08:11:55+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, EMA, eumdr, Europe, European Commission, IVD, IVDR, MDR, Medical Devices, Regulatory, Regulatory Affairs|
Handover of expert panels on medical devices and in vitro diagnostics to EMA Now, the European Medicines Agency has control of the Expert Panels on medical devices and in vitro diagnostic medical devices. On 1 March, the coordination [...]
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_04792022-10-06T09:26:30+00:00January 3rd, 2022|Categories: Compliance, Regulatory|Tags: Compliance, eumdr, IVDR, Regulatory Affairs|
EUDAMED ACTOR MODULE FAQs - update 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). [...]
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.janecek2022-10-06T14:49:12+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Eudamed, Europe, IVDR, MDR, Regulatory|
Turkey: New MDR and IVDR are applicable 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 [...]
adminMTE_04792021-04-22T10:29:12+00:00April 22nd, 2021|Categories: Clinical Trial, Europe, MDR|Tags: Austria, Clinical Trial, Europe, IVDR, MDR|
The Austrian Federal Office for Safety in Health Care (BASG) gave information on a new validation process during the transition to the MDR which will come into force in May 2021. Meditrial manages several studies in Austria and has direct [...]
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