Implementing a Compliant Solution for Electronic Distribution of Instructions for Use
Read our online article regarding the eIFU implementation process
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MDCG 2020-12 on devices incorporating a medicinal product!
MDCG released its guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using transmissible spongiform encephalopathy (TSE) susceptible animal tissues.
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ISO Technical Report 24971:2020 Published!
The International Organization for Standardization (ISO) published the long-delayed Technical Report 24971, a companion document for the recently updated risk management standard ISO 14971.
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Updated MIR Form and Q&A Guidance!
The European Commission published an updated version of the Manufacturer Incident Reporting Form (v7.2.1.). This publication was accompanied by a “Changelog file” as well as a “Questions and answers document on the implementation of the new MIR form”.
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MDCG Guidance on safety reporting in clinical investigations!
MDCG released a new guidance document and report form addressing how safety reporting in clinical investigations of medical devices should be performed under the MDR.
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MDR officially delayed!
EU Regulation 2020/561 amending MDR 2017/745 on medical devices, as regards the dates of application of certain of its provisions, was published in the Official Journal of the European Union on 24 April 2020. 26 May 2021 is now the official date of full application of the EU’s Medical Device Regulation (MDR).
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IMDRF finalises terminology for Adverse Event Reporting!
The International Medical Device Regulators Forum (IMDRF) posted the 4th edition of the documentation supporting harmonized terminology for reporting adverse events related to medical devices including in-vitro diagnostics (IVDs).
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Another wave of MDCG Guidance Documents!
(MDCG) released five new guidance documents. The new guidance documents offer device manufacturers and notified bodies more details on demonstrating equivalence to existing devices, clinical evidence for legacy devices, templates for post-market clinical follow-up plans and evaluation reports and regulatory requirements for ventilators.
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Proposal to Amend MDR!
The European Commission released a proposal that, if approved by both the EU Parliament and Council, would defer by one year the application of certain provisions of the MDR 2017/745, that would otherwise start to apply from 26 May 2020.
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MDCG guidance for NB audits during COVID-19!
the Medical Device Coordination Group (MDCG) issued guidance to help notified bodies perform audits under the medical devices Directives during the COVID-19 pandemic, including, under certain circumstances, remote audits.
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Wave of MDCG Guidance Documents!
Medical Device Coordination Group (MDCG) released three new guidance documents and two updated guidance documents.
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Swiss MedTech Information Letter!
Switzerland’s MedTech industry association (Swiss MedTech) issued an information letter addressed to all Swiss manufacturers of medical devices.
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New documents on EUDAMED nomenclature!
European Commission released new documents on the European Medical Device Nomenclature (EMDN) basic principles and the structure of the Italian “Classificazione Nazionale Dispositivi medici” (CND), which was selected in March 2019 as the basis for the future European Medical Device Nomenclature.
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New MDCG Guidance on Cybersecurity!
The MDCG 2019-16 document, on cybersecurity for medical devices has been released. This document is intended to provide manufacturers with guidance on how to fulfil all the relevant “General Safety and Performance Requirements” set out in Annex I of MDR and IVDR with regard to cybersecurity.
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