• ReconRecon

    Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Covid cases hit lowest level since June ( CNBC ) ( NPR ) Scott Gottlieb says vaccinations are not the only factor driving U.S. Covid cases down ( CNBC ) Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health (Harvard Law blog ) Covid vaccine passports: Everything we know so far ( CNBC ) White House says no plans to require vacci...
  • 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...
  • RoundupsRoundups

    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...
  • Regulatory NewsRegulatory News

    MDCG prods COVID diagnostic makers to assess variants

    The European Commission’s Medical Device Coordination Group (MDCG) sent a notice to in vitro diagnostic (IVD) makers and their authorized representatives reminding them of their obligation to assess the impact of COVID-19 variants on the performance of their tests.   “The notice underlines the manufacturers’ responsibilities to continually assess the impact of newly identified genetic variants of SARS-CoV-2 on the capability of those IVDs to meet their performance, r...
  • RoundupsRoundups

    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
  • Feature ArticlesFeature Articles

    EU MDR countdown: Readiness of medtech companies in Europe

    Around 75 days before the EU Medical Device Regulation’s May 2021 deadline, a survey was launched to evaluate EU-based medtech companies’ readiness for the impending changes. The findings showed that many manufacturers, particularly those with lower-risk devices, still feel unprepared for the new demands a year after the postponement. Notified bodies no longer seem to pose a major challenge, yet the regulation remains time- and cost-consuming, especially with regard to cli...
  • Regulatory NewsRegulatory News

    Euro Convergence: EU pediatric medicines regulatory framework needs simplification, optimization

    Industry would like to see some “pragmatic” changes to the regulatory process for pediatric medicines in the EU, according to a recent presentation at RAPS Euro Convergence 2021.   These changes include incorporating scientific discussion throughout a product’s life cycle, comparable reporting requirements for pediatric trials to those for adult trials, and optimization and simplification of pediatric investigation plan (PIP) procedures and compliance checks, said Thom...
  • Regulatory NewsRegulatory News

    Euro Convergence: Market access pathways for AI now visible

    The pathways companies will use to bring artificial intelligence or machine learning (AI/ML) medical devices and diagnostics to market in the future are now becoming clear, Loganathan Kumarasamy, head of US compliance services at Zifo Technologies, said at RAPS Euro Convergence 2021.   Devices and diagnostics that make use of AI and ML need regulation specific to the field, Kumarasamy said, pointing out that software in medical devices has long been used safely under e...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

    As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.   Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulato...
  • Regulatory NewsRegulatory News

    Euro Convergence: Mind the gap in MDR's treatment of combo products

    Navigating the re-consultation process for drug-device combination products under EU’s new Medical Device Regulation can be tricky business, said panelists during a session at Euro Convergence 2021.   Speakers at the combination products-focused session shared experiences and highlighted gaps where manufacturers still need clarity from competent authorities, who themselves are feeling the strain of implementing new regulations while they continue to sort out post-Brexi...
  • Regulatory NewsRegulatory News

    Euro Convergence: How orphan drug suppliers can win labelling exemptions

    A strong local presence in EU markets is needed when seeking labelling exemptions that help reduce the cost of providing orphan products, according to experts who spoke at RAPS Euro Convergence 2021.   Manufacturers of orphan drugs can gain exemptions from some labelling requirements at an EU level and from individual member states, a potentially valuable flexibility for companies that make orphan drugs targeting very small numbers of patients. Such products face speci...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 2: How to build a regulatory strategy, tackling IVDR and more

    The second day of RAPS Euro Convergence 2021 will bring attendees updates on challenges ahead for implementing the new In Vitro Diagnostic Regulations (IVDR), optimized strategies for drug development, why Europe may be lagging in medical technology and more.   Medical device strategies that span the Atlantic On 11 May, Chrisophe Amiel of Voisin Consulting Life Sciences (VCLS) will address how firms can build a strategy for medical devices and electronic health tec...