adminMTE_04792023-03-31T13:14:00+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 [...]
adminMTE_04792023-04-21T11:02:51+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 [...]
adminMTE_04792024-02-29T17:06:58+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 The FDA aims to publish the draft guidance this year.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 [...]
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 [...]
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_04792024-02-29T16:50:47+00:00September 25th, 2020|Categories: Clinical Trial, Compliance, Regulatory, USA|Tags: FDA, Regulatory, USA|
The U.S. Food and Drug Administration (FDA) has issued a guidance document on the use of ISO 10993-1 in the assessment of medical devices that come in direct or indirect contact with the human body. The standard is recognized [...]
adminMTE_04792024-02-29T16:38:59+00:00September 3rd, 2020|Categories: Clinical Trial, Compliance, Regulatory, Software, USA|Tags: Clinical Trial, Digital Health, FDA, Regulatory, USA|
The FDA issued a guidance for the selection of patient-reported outcome (PRO) instruments in clinical evaluation of their products. The guidance details such topics as modification or adaptation of existing PRO instruments as well as the possibility of including [...]
k.janecek2020-08-24T08:31:47+00:00August 24th, 2020|Categories: Compliance, Europe, MDR, Regulatory|Tags: Europe, European Commission, European Union, MDR, Regulatory|
On August 19th, 2020 the European Commission implemented regulation as regard common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under the MDR, single-use devices may be reprocessed where permitted by national law. Reach [...]
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