• Feature ArticlesFeature Articles

    New claims under EU MDR and EU IVDR

    This article discusses medical device promotional and advertising product claims under Article 7 of the European Union’s new Medical Devices Regulation ( EU MDR) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR) and examines how and when product claims are misleading or false as defined under the regulations. Introduction    Article 7 of the EU MD R 1 and EU IVDR 2 provide new claims regulations for medical devices. All of the requirements relate ...
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    Preparing for EU MDR translation

    This article discusses what medical device manufacturers need to know about product information language translation as required by European Medical Devices Regulation ( EU MDR ). The author addresses how companies can better meet the regulation’s language component requirements and offers suggestions ranging from being aware of who the information reading audience is and hiring professional translators.   Introduction   The complex regulatory requirements for EU ...
  • Regulatory NewsRegulatory News

    COVID-19 IVD quality problems drive EC guidelines

    A “mismatch” between the expected and actual quality of coronavirus (COVID-19) tests has spurred new guidelines from the European Commission (EC). The guidelines are part of a roadmap to lifting the lockdown measures implemented to curb the spread of the disease across the European Union, according to an EC statement dated 15 April.   Governments across the European Union (EU) are working to step up testing capacity, recognizing that testing will play a key role in e...
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    COVID-19: FDA, EMA and 16 drugmakers take part in development effort

    The National Institutes of Health (NIH) on Friday announced a new initiative to accelerate the development of treatments and vaccines for coronavirus disease (COVID-19) involving the US Food and Drug Administration (FDA) and other US health agencies, the European Medicines Agency (EMA) and 16 drugmakers.   The goal of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will be to develop a coordinated research strategy to prioritize dru...
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    EU Regulatory Roundup: EMA shares advice on validated computer systems used in clinical trials

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA shares advice on validated computerized systems used in clinical trials   The European Medicines Agency (EMA) has published a notice about validating and qualifying all types of computerized systems used in clinical trials. EMA released the notice in response to “recent inspection findings” and their implications for the “integrity, reliability, robustness and accep...
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    FDA, EC offer guidance on COVID-19 convalescent plasma

    The US Food and Drug Administration (FDA) and European Commission (EC) recently released guidance on convalescent plasma collected from individuals who have recovered from COVID-19 and which may potentially be used as a treatment for COVID-19. FDA’s 9-page guidance, which follows the agency’s granting of the use of single patient emergency Investigational New Drug Applications (eINDs) to the investigational plasma, is meant to provide recommendations to health care pr...
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    MDCG explains when devices can be exempt from premarket clinical consultations

    The Medical Device Coordination Group (MDCG) recently updated its guidance on interpreting Article 54(2)b of the Medical Devices Regulation (MDR), which discusses the criteria that exempt devices from the premarket clinical evaluation consultation procedure with expert panels. According to the text of the article, the clinical evaluation consultation procedure shall not been required when: (a) a firm is renewing certificate under MDR; (b) a device “has been design...
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    Notified body audits during the pandemic: New MDCG guidance

    The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits. The 5-page guidance deals strictly with surveillance audits under the medical devices directives, audits conducted for recertification purposes under the directives, in cases where a manufacturer submits a change notification to a notified body that would typically require an on-site ...
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    Eudamed’s delay and its impact on clinical investigations under the EU MDR

    This article reviews possible ramifications caused by the delay in launching the European Union’s new electronic database, the European Database on Medical Devices (Eudamed).The author discusses potential issues when clinical investigation data is not transparent or accessible. Until Eudamed is available, posting study results on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinic...
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    EC offers antitrust reassurances to generic drugmakers cooperating on shortages

    The European Commission on Wednesday reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients. The commission explains how generic firms may need to coordinate on stock management and distribution “so that not all undertakings focus on one or a few medicines, while others remain in under-production. Such coordination would be contrary to ant...
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    New system to speed industry-EMA interactions on drug shortages

    The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday. Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceu...
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    EMA advises on compassionate use programs for remdesivir

    The European Medicines Agency (EMA) on Friday released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials.   EMA says it received requests from four EU member states, Estonia, Greece, the Netherlands and Romania, asking for advice on providing early access to the drug.   Initially developed as an antiviral therapy to t...