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.janecek2022-08-26T08:10:42+00:00March 11th, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: Clinical Trial, Compliance, Europe, medicaldevice, medicaldevices, medicines, Regulatory Affairs, Spain|
Spain: AEPD approves the first industry code of conduct to enable compliance of clinical research and pharmacovigilance with the GDPR The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the [...]
k.janecek2022-08-26T08:11:26+00:00March 8th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: Compliance, Europe, Medical Devices, MedTech, Regulatory Affairs, Switzerland|
Swiss Single Registration Number - CHRN The Swiss Single Registration Number (CHRN) is assigned by Swissmedic based on the Medical Device Ordinance (MedDO; SR 812.213). It is assigned to Swiss manufacturers, authorised representatives or importers and serves to [...]
k.janecek2022-08-26T08:11:38+00:00March 4th, 2022|Categories: Compliance, Europe, Regulatory, Switzerland|Tags: Compliance, Europe, MedTech, Regulatory, Regulatory Affairs, Switzerland|
Swiss Medical Device Database is Under Construction Swissmedic is in the process of developing a new database for registering economic operators and medical devices. Due to the continuing aim of equivalence between regulation in Switzerland and the EU, the [...]
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.janecek2022-08-26T08:12:13+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: CDRH, Clinical Trial, Compliance, FDA, Medical Devices, MedTech, Regulatory, Regulatory Affairs, USA|
US: FDA guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to [...]
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.janecek2022-08-26T09:16:03+00:00February 8th, 2022|Categories: Compliance, FDA, Regulatory, USA|Tags: 510K, Compliance, FDA, medicines, MedTech, Regulatory Affairs, USA|
US: The FDA has finalized guidance on the use of premarket pathways for combination products The FDA has finalized guidance on the use of premarket pathways for combination products. The document defines combination products, the coordination between the [...]
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 [...]
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