Meditrial Editorial Team2023-03-31T13:15:38+00:00March 1st, 2021|Categories: Europe, Regulatory|Tags: Eudamed, Europe, MDCG|
The MDCG issued a new guidance "to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions [...]
Meditrial Editorial Team2023-04-21T10:48:30+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: ASCA, CDRH, Conformity Assessment, FDA, USA|
The US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) annouced the full launch of a pilot conformity assessment program in 2021. Contact Meditrial to know about our strategic assessments of regulatory requirements to address business [...]
Meditrial Editorial Team2023-04-21T11:02:51+00:00January 25th, 2021|Categories: Compliance, Innovation, Regulatory|Tags: ISO, Regulatory|
ISO issued a revision of ISO 10993-1: "ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation". The revised standard "specifies the procedure for the assessment of medical devices and their constituent materials with regard to their [...]
Meditrial Editorial Team2024-02-29T14:05:00+00:00January 4th, 2021|Categories: Compliance, Regulatory, UK|Tags: MHRA, UK|
As of 1 January, 2021 new relationships between the UK and the EU came into force. Among others this will impact the medtech industry with new requirements for market access and device registration. Meditrial offers market access and regulatory [...]
Meditrial Editorial Team2023-03-31T16:32:08+00:00December 1st, 2020|Categories: Compliance, Regulatory, UK|Tags: European Union, MHRA, UK|
The UKCA (UK Conformity Assessed) marking will be the UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland) as of January 1st 2021. Meditrial offers market access and [...]
Meditrial Editorial Team2023-03-31T16:17:03+00:00November 17th, 2020|Categories: Compliance, Europe, Regulatory|Tags: Europe, European Commission, IVD, IVDR, MDCG, Regulatory|
The European Commission’s Medical Device Coordination Group (MDCG) released a guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR). The guide provides industry a clarification on how to accurately classify diagnostics under the [...]
Meditrial Editorial Team2024-02-29T15:06:23+00:00November 13th, 2020|Categories: Regulatory, Switzerland, UK|Tags: Clinical Trial, Europe, Regulatory, Switzerland, UK|
The UK’s Department for International Trade in Switzerland announced a virtual information session specially for Swiss medtech and medical device companies, to give an update on latest policy developments and regulatory guidance. The event will take place online on [...]
Meditrial Editorial Team2024-02-29T16:45:09+00:00October 22nd, 2020|Categories: Clinical Trial, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The FDA introduced a new Medical Device Development Tools (MDDT) for the investigation of medical devices. Through the MDDT program, the FDA defines tools that medical device sponsors can use in the development and evaluation of medical devices. The [...]
k.janecek2024-02-29T13:56:00+00:00October 9th, 2020|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, European Union, Regulatory|
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). The Committee will take over the tasks of the Healthcare and Youth Inspectorate (IGJ) [...]
k.janecek2024-02-01T16:41:27+00:00September 29th, 2020|Categories: Clinical Trial, Covid-19, Regulatory|Tags: Canada, Clinical Trial, Covid-19, Regulatory|
Health Canada published two guidance documents aimed at improving clinical trials for medical devices and medicines during the COVID-19 pandemic. New trialsTo reduce regulatory burden, Health Canada has developed a new regulatory pathway, the interim order for clinical trials for medical [...]
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