adminMTE_04792024-02-29T14:05:00+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 [...]
adminMTE_04792023-03-31T16:32:08+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 [...]
adminMTE_04792023-03-31T16:17:03+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 [...]
adminMTE_04792024-02-29T15:06:23+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 [...]
adminMTE_04792024-02-29T16:25:13+00:00November 3rd, 2020|Categories: Clinical Trial, Innovation, Software, UK|Tags: Clinical Trial, Digital Health, Innovation, MHRA, UK|
UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials. The guidance is intended to support sponsors with planning clinical research and making regulatory decisions. MHRA exaplained that real-world data source in [...]
adminMTE_04792024-02-29T16:45:09+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 [...]
adminMTE_04792024-02-29T14:41:05+00:00October 21st, 2020|Categories: Clinical Trial, Europe, USA|Tags: Clinical Trial, Europe, IMDRF, Regulatory, USA|
The International Medical Device Regulators Forum (IMDRF) has issued an update proposal to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices. The proposal will be open for consultation untill 11 December 2020. The update includes advice [...]
adminMTE_04792024-02-29T16:51:55+00:00October 20th, 2020|Categories: Clinical Trial, USA|Tags: Clinical Trial, Digital Health, FDA, Innovation, USA|
The U.S. Food and Drug Administration recently launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). "The launch of the Digital Health Center of Excellence is an important step in furthering 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) [...]
adminMTE_04792020-09-30T14:06:33+00:00September 30th, 2020|Categories: Clinical Trial, Europe, Innovation, Software|Tags: Clinical Trial, Digital Health, EMA, Europe, Innovation|
Digital health technologies are becoming increasingly relevant for the conduct of clinical trials. As a demonstration, the European Medicine Agency (EMA) recently established an Innovation Task Force, "a multidisciplinary group that includes scientific, regulatory and legal competences [...] to provide [...]
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