k.janecek2024-02-26T16:46:14+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 [...]
k.janecek2024-02-29T15:05:43+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Eudamed, Europe, IVDR, MDR, Regulatory|
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 harmonized with European Union legislation, aims to improve [...]
k.janecek2024-02-29T14:30:34+00:00May 27th, 2021|Categories: Clinical Trial, Compliance, Europe, Switzerland|Tags: Clinical Trial, Europe, MDR, Regulatory, Switzerland|
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 to offset the negative consequences of the absence of the MRA update and [...]
adminMTE_04792023-03-31T09:04:26+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_04792024-02-29T16:33:44+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 [...]
adminMTE_04792023-03-31T09:12:27+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 connections [...]
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 [...]
adminMTE_04792023-03-31T12:43:00+00:00March 31st, 2021|Categories: Clinical Trial, Compliance, Regulatory|Tags: Clinical Trial, ICH, International Council for Harmonisation, Regulatory|
The International Council for Harmonisation (ICH) is working on the revision of E6 (R2) Good Clinical Practice, the guidace addressing GCP to provide a unified standard for the ICH region and to facilitate the mutual acceptance of clinical data. Meditrial [...]
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