MHRA Guidance on regulating Medical Devices!
MHRA published its Guidance on Regulating medical devices from 1 January 2021, thus after the Brexit transition period ends. The UK will have its own regulatory regime as of 1 January 2021, and it will include a number of changes to how medical devices and IVDs are placed on the market in Great Britain.
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EUDAMED Actors Registration Module!
On 18 August 2020, the European Commission’s Medical Devices Coordination Group (MDCG) published MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.
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UDI FAQ
The European Commission has published a Q&A document explaining how the Unique Device Identification (UDI) system will work under the EU medical devices Regulations 2017/745 and 2017/746.
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Common Specifications for the reprocessing of single-use medical devices under the MDR!
The European Commission issued the implementing regulation 2020/1207 establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). It enters into force on 29 August 2020 and will fully apply on date of application of the Medical Device Regulation 2017/745, i.e. 26 May 2021.
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New MDCG Guidance Documents!
MDCG published a template for clinical evaluation assessment reports (CEAR), and a guidance explaining how Notified Bodies may make use of MDSAP audit reports when performing surveillance audits under Regulation 2017/745 Medical Devices Regulation (MDR) and Regulation 2017/746 In Vitro Diagnostic medical devices Regulation (IVDR).
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Fact sheet on Transparency and Public Information!
The European Commission has released a fact sheet explaining what information will be made public according to transparency obligations under Regulation 2017/745 Medical Devices Regulation (MDR), even though some of those requirements will not be applicable until the European database on medical devices (EUDAMED) is fully functional.
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ISO Technical Report 20416:2020 Published!
The International Organization for Standardization (ISO) published the Technical Report 20416:2020 on Medical devices - Post-market surveillance for manufacturers.
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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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