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  • Regulatory NewsRegulatory News

    Eudamed actor registration module set to launch in December

    In a position paper released Tuesday, the European Commission’s Medical Device Coordination Group (MDCG) confirmed that the Eudamed actor registration module will be deployed on 1 December 2020.   The module was previously expected in May, but its deployment was pushed back by the Commission just before its launch date to reflect the postponed date of application of Eudamed. At the time, the Commission said it would pursue a phased rollout of the six Eudamed modules ...
  • Regulatory NewsRegulatory News

    MDR/IVDR Guidance: MDCG Explains What’s Coming

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE). The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 202...
  • Regulatory NewsRegulatory News

    MDCG Updates Q&As on Requirements for Notified Bodies

    The European Commission’s Medical Device Coordination Group (MDCG) recently added about six pages worth of questions and answers (Q&As) to its document on requirements relating to notified bodies (NBs). The update to the document, which was first released in June , comes as five NBs have been designated under the Medical Device Regulation (MDR), while one NB has been designated under the In Vitro Diagnostic Regulation (IVDR). Most of the information related to o...
  • Regulatory NewsRegulatory News

    EC Unveils Designating Authority’s Final Assessment Form Under MDR, IVDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released a final assessment form for authorities designating conformity assessment bodies (CABs) and notified bodies (NBs) under the EU Medical Devices Regulation (MDR), which takes effect next May, and the In Vitro Diagnostic Regulation (IVDR), which takes effect in May 2022. The form includes space to describe the assessment carried out by the designating authority and whether all correctiv...
  • Regulatory NewsRegulatory News

    Classifying Software Under MDR, IVDR: New Guidance From MDCG

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The guidance discusses certain types of software that would be classified under MDR or IVDR, such as software that can directly control a (hardware) medical device (e.g. radiotherapy treatm...
  • Regulatory NewsRegulatory News

    EC Offers MDR Guidance on New Safety and Clinical Performance Summary

    The European Commission’s Medical Device Coordination Group recently released guidance to help manufacturers create a new summary of safety and clinical performance (SSCP), as required by the EU’s Medical Devices Regulation (MDR) for implantable devices and for class III devices that are not custom-made or investigational. The SSCP, which will be validated by a notified body (NB) and made publicly available via the EU database on devices known as Eudamed, is expected to...
  • Regulatory NewsRegulatory News

    EU Device Coordination Group Offers Eudamed Guidance

    The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed. The two-page document on the registration of data elements explains how the text of the Medical Device Regulation (MDR) presents an inconsistency with regard to what different articles wi...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: Industry Finds Fault With UK Vision for Drug Regulation After Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   Industry Finds Fault With UK Vision for Drug Regulation After Brexit   British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The trade groups found fault with proposals for how the Medicines and Healthcare products Regulatory Agency (MHRA) will handle orphan drugs, regulatory fees, ...
  • Feature ArticlesFeature Articles

    The Medical Device Coordination Group: a new Authority Under EU Device Regulations

    This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdi...