Post-BREXIT EU relations with the United Kingdom and impact on medical devices

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 solutions for devices manufacturers. The Meditrial

2021-01-04T09:55:01+00:00January 4th, 2021|Compliance, Regulatory, UK, Uncategorized|

UK: Get ready for UK market access and the new UKCA requirements

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 regulatory solutions for devices manufacturers. The

2020-12-01T11:58:30+00:00December 1st, 2020|Compliance, Regulatory, UK|

EU: MDCG releases IVD classification guidance

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 IVDR’s risk-based classification system. “In

2020-11-17T10:36:52+00:00November 17th, 2020|Compliance, Europe, Regulatory|

UK information session for Swiss medtech companies

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 Monday, 16 November 2020, 15:00 -

2020-11-13T09:59:17+00:00November 13th, 2020|Regulatory, Switzerland, UK, Uncategorized|

UK: MHRA supports generating RWE in clinical trials through digital solutions

UK MHRA has issued a draft guidance on the use of real-world evidence (RWE) in clinical trials.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 clinical trials “has the potential for

2020-11-03T09:50:00+00:00November 3rd, 2020|Clinical Trial, Innovation, Software, UK|

US: FDA introduces new Medical Device Development Tools for sponsors

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 newly introduced tool is "Rubric for

2020-10-22T09:00:35+00:00October 22nd, 2020|Clinical Trial, Regulatory, USA|

The International Medical Device Regulators Forum (IMDRF) issued an update on PMCF studies

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 on the design, implementation, and appropriate

2020-10-21T09:29:59+00:00October 21st, 2020|Clinical Trial, Europe, USA|

US: FDA launches the Digital Health Center of Excellence

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 agency’s overarching dedication to the advancement

2020-10-20T08:53:04+00:00October 20th, 2020|Clinical Trial, USA|

Netherlands: Notifications of clinical investigations with medical devices to CCMO as of the 1st of October

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) for processing notifications for clinical trials

2020-10-09T10:02:36+00:00October 9th, 2020|Clinical Trial, Compliance, Europe, MDR, Regulatory|

EU: EMA supports digital health technologies in clinical trials

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 a forum for early dialogue

2020-10-01T09:25:00+00:00September 30th, 2020|Clinical Trial, Europe, Innovation, Software|
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