adminMTE_04792024-02-29T16:27:55+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 [...]
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_04792024-02-29T14:41:05+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 [...]
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 [...]
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 [...]
adminMTE_04792024-02-23T16:35:16+00:00August 11th, 2020|Categories: Compliance, Europe, Regulatory|Tags: Europe, European Commission, IVDR, MDCG, MDR, Regulatory|
The EU Commission’s Medical Device Coordination Group issued a guidance providing details on how notified bodies can reference Medical Device Single Audit Program audit reports when planning surveillance audits under the MDR or IVDR. Meditrial can help you to [...]
adminMTE_04792024-02-29T14:40:29+00:00July 20th, 2020|Categories: Clinical Trial, Compliance, Europe, MDR|Tags: Clinical Trial, Europe, European Commission, MDCG, MDR|
The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices according to transparency [...]
adminMTE_04792024-02-02T11:58:44+00:00July 13th, 2020|Categories: Clinical Trial, Compliance, Europe|Tags: Clinical Trial, Europe, European Commission, USA|
The European Commission together with the European regulatory agencies EMA (European Medicines Agency) and HMA (Heads of Medicine), released a statement to urge sponsors to comply with clinical trials rules after Brexit. The deadline for compliance is 31st December [...]
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