k.janecek2023-03-29T14:01:39+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|Tags: Compliance, Europe, European Commission, European Union, IVD, IVDR, MDR, Medical Devices, MedTech|
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 enumerations v2.7 MDR and IVDR introduce an EU device [...]
k.janecek2023-03-29T14:01:53+00:00March 24th, 2022|Categories: Compliance, Europe, MDR, Regulatory|Tags: Compliance, eumdr, Europe, European Commission, European Union, MDR, Medical Devices, MedTech, Regulatory, Regulatory Affairs|
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 joint statement, they call for three important points and [...]
k.janecek2023-03-29T14:04:04+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, EMA, eumdr, Europe, European Commission, IVD, IVDR, MDR, Medical Devices, Regulatory, Regulatory Affairs|
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 Secretariat of the Commission’s expert panels on medical devices and in vitro diagnostic medical devices has been [...]
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.janecek2023-03-29T14:15:44+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.janecek2023-03-29T15:56:59+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Eudamed, Europe, European Commission, European Union, MDCG, Regulatory|
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 of actors not subject to registration requirements under the Art. 31 Medical Device [...]
adminMTE_04792023-03-31T09:37:46+00:00April 19th, 2021|Categories: Europe, MDR|Tags: Europe, European Commission, IVD, MDCG|
The European Commission Medical Device Coordination Group (MDCG) adopted a new standardization request for harmonized European standards in support of the MDR and IVDR after its initial standardization request was rejected last year.Contact Meditrial for a free consultation regarding your device! [...]
adminMTE_04792023-03-31T09:46:24+00:00April 12th, 2021|Categories: Compliance, Europe|Tags: Europe, European Commission, IVDR, MDCG|
The transition period to the new in vitro diagnostic regulation (IVDR) in the EU will last till next 26 May, 2022. In order to inform device manufacturers, the European Commission´s Medical Device Coordination Group issued a Q&A including information on [...]
adminMTE_04792023-03-31T11:05:13+00:00April 7th, 2021|Categories: Europe|Tags: Digital Health, Europe, European Commission|
The European Commission has established a new executive agency, the European Health and Digital Executive Agency (HaDEA) for digital and health projects. The agency is expected to help Europe emerge stronger from the COVID-19 pandemic.The new HaDEA will be responsible [...]
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