e.alvarado2022-07-05T08:28:58+00:00June 22nd, 2022|Categories: Meditrial|Tags: CLINICAL PRACTICE, Devices, EDC, EU-MDR 2017/745, MDR, Medical Devices, PMCF, PMS, Post-market clinical follow-up, Post-market surveillance, Postmarketing, Surveillance|
After more than 20 years, new legislation, the "Medical Device Regulation" (EU-MDR 2017/745), has come into force in Europe. The triggers for the initiation and implementation of this European law, which is much stricter than previous directives, were scandals related [...]
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.janecek2022-08-26T08:10:00+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.janecek2022-08-26T08:11:55+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.janecek2022-10-06T14:31:20+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 [...]
k.janecek2022-10-06T14:50:59+00:00May 27th, 2021|Categories: Clinical Trial, Compliance, Europe, Switzerland|Tags: Clinical Trial, Europe, MDR, Regulatory, Switzerland|
Switzerland: New regulations applicable to medical devices as of 26 May 2021 Additional provisions have been adopted for the new Medical Device Regulation (MedDO) in Switzerland and enter into force on 26 May 2021. This action was taken [...]
adminMTE_04792021-05-06T14:41:06+00:00May 6th, 2021|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, Germany, MDR, Regulatory|
The medical device regulation EU 2017/745 allows Member States some adjustments for local implementation. If you sponsor a trial in Germany, you must learn what are the new ordinances and guidelines for the implementation of the MDR. [...]
adminMTE_04792021-05-05T16:32:09+00:00May 5th, 2021|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, MDR, Regulatory|
WHY WE MUST UPDATE OUR TRIALS If you sponsor a trial that is already ongoing, you must update your safety procedures in accordance with the MDR by the deadline of May 26, 2021. If you are just [...]
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