• Regulatory NewsRegulatory News

    MDCG urges manufacturers to use MDR transition period wisely

    The European Commission’s Medical Device Coordination Group (MDCG) on Monday said that manufacturers should start preparing now to ensure “timely compliance” with the Medical Device Regulations (MDR) by the time the regulation is fully applicable on 27 May 2024. Devices not certified by this date will no longer have access to the EU market, except in rare circumstances discussed in the notice.   MDCG reiterated that “to ensure that devices can continue to be placed o...
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    Stakeholders ask for more time to transition EUA devices, diagnostics

    Responding to two US Food and Drug Administration (FDA) draft guidances on transitioning products granted emergency use authorization (EUA) during the pandemic to regular marketing authorizations, key stakeholders raised concerns the agency isn’t providing enough time to collect the necessary data or make labeling changes after the current public health emergency (PHE) is over.   In December, FDA published two much-anticipated draft guidances titled, “ Transition Plan ...
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    FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies

    The US Food and Drug Administration (FDA) is proposing to give medical device makers 180-days’ notice before terminating emergency use authorizations (EUAs) and phasing out its enforcement policies for medical devices issued during the COVID-19 public health emergency (PHE).   The transition plan comes in the form of two draft guidances issued in late December, in which FDA explains that the transition policies are intended to “prepare manufacturers and other stakehold...
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    Pharmacovigilance and QPPV: Post-transition guidance from MHRA

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this week issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for UK authorized products.   Pharmacovigilance   MHRA says it “will retain responsibility for pharmacovigilance across the UK from 1 January 2021,” but notes that there will be di...
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    MHRA: Post-transition guidance on licensing medicines

    In its suite of post-transition guidances released Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021.   The guidance, which largely mirrors the “no deal” scenario laid out in now-withdrawn guidance issued last year, explains a range of issues from converting centrally authorized products (CAPs) to UK marketing au...
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    MHRA posts suite of post-transition guidances

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.   Clinical trials   Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial ...