• Regulatory NewsRegulatory News

    MDCG offers guidance on clinical investigations in Eudamed’s absence

    The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance providing a set of templates that will be used to fulfill the application/notification submission requirements for clinical investigations under the Medical Device Regulation (MDR) prior to the availability of the Eudamed clinical investigations and performance studies module.   Under MDR, sponsors of clinical investigations for medical devices are required to submit an appli...
  • Feature ArticlesFeature Articles

    The importance of the device label to a global UDI system

    Variance between medical device regulations in different jurisdictions complicates creation of a global unique device identification (UDI) system, causing compliance barriers for manufacturers and adoption barriers for device users. As regulatory agencies advance their UDI initiatives, we reflect on the principles guiding this system not only for regulatory purposes, but as essential to improving the value of healthcare supply chain, clinical, and research data. This artic...
  • Regulatory NewsRegulatory News

    MDCG issues guidance on Eudamed alternatives

    The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system.   While the first of six Eudamed modules was made available late last year, the remaining modules are expected to be rolled out by the database’s May 2022 date of application. Some modules, ...
  • Regulatory NewsRegulatory News

    European Commission explains management of legacy devices in Eudamed

    The European Commission this week posted a new document explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database.   After being delayed in 2019, Eudamed, a critical component of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched with the first of its six modules operational in December 2020. The remaining five modules are expected to roll out by the database’s May 2022 date of a...
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    Eudamed launched with actor registration module live

    The European Commission’s Eudamed database, a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched on Tuesday with the actor registration module available to member states and economic operators.   “Eudamed will provide a living picture of the lifecycle of medical devices that are made available in the [EU],” the Commission writes, noting that the aim of the database is to increase transparency for medi...
  • Regulatory NewsRegulatory News

    Eudamed: EC posts info on actor registration module

    With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.   The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. (RELATED: Eudamed actor registration module set to ...
  • Regulatory NewsRegulatory News

    MDR/IVDR update: Experts share what keeps them up at night

    Speaking virtually at RAPS Convergence on Monday, top European medical device and in vitro diagnostic (IVD) experts shared what keeps them up at night as the date of application for both the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) approach.   With MDR delayed to May 2021, and with Eudamed’s full rollout and the IVDR date of application seemingly on track for May 2022, regulators, industry and notified bodies have much to prepare...
  • 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

    Eudamed to Launch in 2022 for Both Devices and IVDs

    The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. The two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Dev...
  • 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...