Meditrial Editorial Team2023-03-31T13:14:00+00:00February 15th, 2021|Categories: Compliance, Europe, MDR|Tags: Eudamed, Europe, European Commission, Regulatory|
The European Commission issued a new guidance explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database, expected to be fully rolled out by May 2022. "Legacy Devices are defined as Medical Devices, Active [...]
Meditrial Editorial Team2023-03-31T13:12:41+00:00February 9th, 2021|Categories: Clinical Trial, Covid-19, Europe|Tags: Clinical Trial, Covid-19, EMA, European Commission, Remote Source Data Verification, rSDV|
The European Commission and European Medicines Agency’s updated the guidance on managing clinical trials conducted during the COVID-19 pandemic by expanding the use and scope of remote source data verification (rSDV) in clinical trials. While previous versions of the guidance [...]
Meditrial Editorial Team2024-02-29T16:27:55+00:00February 4th, 2021|Categories: UK|Tags: Europe, MHRA, Regulatory, UK, UKCA|
The UK MHRA has updated a guidance on virtual manufacturing of medical devices. "A virtual manufacturer is an organisation that fully sources its own named product from another company [...] which has designed and manufactured an identical UKCA/CE/CE UKNI [...]
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 Team2024-02-29T17:06:58+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: AI, Artificial Intelligence, Digital Health, FDA, Machine Learning, Regulatory, SaMD, Software|
The FDA has released an action plan to develop a regulatory framework on artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). The FDA aims to publish the draft guidance this year. As a Digital Research Organization, Meditrial [...]
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 [...]
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