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.janecek2022-08-24T16:09:53+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: Clinical Trial, Compliance, EMA, Europe, MedTech, Regulatory, Regulatory Affairs|
EMA’s advice to sponsors on managing the impact of the war in Ukraine on clinical trials EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war [...]
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.janecek2022-08-26T08:11:26+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.janecek2022-08-26T08:12:13+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.janecek2022-08-26T09:16:03+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 [...]
adminMTE_04792022-09-30T15:53:14+00:00January 28th, 2022|Categories: Regulatory|Tags: Conformity Assessment, EU IVDR, Invitro Diagnostics, MedTech, Post Market Surveillance, Regulatory Affairs|
MDCG 2022-2 Guidance on general principles of clinical evidence for in Vitro Diagnostic medical devices (IVDs) New #MDCG Guidance on general principles for #clinicalevidence and the continuous process of performance evaluation for #IVDs has been published The guidance describes the approach by which [...]
adminMTE_04792022-10-06T11:12:50+00:00October 16th, 2021|Categories: Digital Health, Europe, Regulatory|Tags: EMA, medicines, MedTech, Patient Experience, Pharma, Regulatory Affairs, Technology|
PREFER patient input to decision making under evaluation 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 [...]
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