• RoundupsRoundups

    Euro Roundup: MHRA shares guidance on coordinated assessment pathway for device trials

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the coordinated assessment pathway it is piloting to streamline the review of clinical investigations involving medical devices.   MHRA and the Health Research Authority (HRA), which makes sure research is ethically reviewed and approved, are working together to test the pathway. The two organizations are sharing information on their assessments of medical device clinical investi...
  • Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 1: Definitions, regulations, and documentation

    This article compares and contrasts the regulatory requirements for herbal medicinal products, herbal-based medical devices, and botanical food supplements in the EU. It provides an overview of the current framework, highlights areas of controversy, and presents recent regulatory developments. The article is the first of two on this topic. The current article presents the definitions, main regulations, and documentation requirements for placing the products on the market;...
  • Regulatory NewsRegulatory News

    Europe’s MDCG offers guidance on legacy medical devices, repackaging

    A new guidance document from the European Commission’s Medical Device Coordination Group (MDCG) spells out how the newly implemented Medical Device Regulation (MDR) will be applied to legacy devices and devices placed on the market prior to the 26 May 2021 MDR rollout.   In the guidance , MDCG takes the position that the MDR’s post-market surveillance, market surveillance, and vigilance requirements apply to legacy devices. The surveillance of legacy devices by notifi...
  • Regulatory NewsRegulatory News

    New MDCG guidance shows how devices fit into MDR’s classification rules

    The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.   Under the MDR , which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest.  Annex VIII of the...
  • Regulatory NewsRegulatory News

    Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

    Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.   Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused...
  • Regulatory NewsRegulatory News

    New MDCG guidance offers QMS roadmap for device repackaging, relabeling

    Notified bodies who certify quality management systems related to device repackaging and relabeling have new guidance from the European Commission’s Medical Devices Coordinating Group (EC’s MDCG).   The guidance covers activities conducted under Article 16(4) of the Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR) related to repackaging and relabeling of medical devices. The overall goal of the notified body’s certification activities under t...
  • Regulatory NewsRegulatory News

    Notified bodies report success — and some drawbacks — using remote audits

    Remote audits conducted by notified bodies have been successful in ensuring that medical device manufacturers are complying with the EU’s Medical Device Regulation and In Vitro Diagnostics Regulation, according to a recently conducted survey  of 46 notified bodies, with remote audits uncovering roughly the same number of deficiencies as onsite audits.   The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB), located in Liège...
  • RoundupsRoundups

    Euro Roundup: EDQM says remote inspections could be third pillar for GMP oversight

    Real-time remote inspections piloted during the COVID-19 pandemic could serve as a third pillar for the supervision of active pharmaceutical ingredient (API) manufacturers, the European Directorate for the Quality of Medicines (EDQM) said.   EDQM began piloting real-time remote inspections, which it refers to by the abbreviation RTEMIS, in 2020 in response to travel restrictions. With the vast majority of the around 40 on-site inspections EDQM performs each year happen...
  • Regulatory NewsRegulatory News

    MDCG outlines Eudamed obligations for legacy, custom devices

    The European Commission’s Medical Device Coordination Group (MDCG) last week released a questions and answers guidance detailing how Eudamed rules apply to actors not subject to registration requirements under the medical devices regulation (MDR) and in vitro diagnostic regulation (IVDR), including manufacturers of custom-made and legacy devices.   The guidance also clarifies situations in which an Actor ID is issued instead of a single registration number (SRN). An ...
  • Feature ArticlesFeature Articles

    May’s Regulatory Focus: EU MDR and EU IVDR update, and more

    Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR). The 26 May deadline for the MDR has come and gone, and the regulation is now being fully applied after a yearlong delay because of the pandemic. Next up is the application deadline for the IVDR, now set for 26 May 2022. Articles in this issue examined the extent of preparedness among regulators, sponsors, and manufacturers for the two application ...
  • Regulatory NewsRegulatory News

    MDR's Day One: Experts weigh in

    Editor’s note: Today, MDR comes into effect. We took the opportunity to check in with medical device regulatory experts now that the day is at hand. This “ News in Focus ” article is the first in an occasional series where we will provide expert perspective or opinion on regulatory news. Look to Regulatory Focus for more insights on other topics in the coming weeks.   In the EU, the day has come. On Wednesday, the European Commission applied the updated suite of re...
  • ReconRecon

    Recon: CMS head confirmed; EU seeks breach-of-contract fine from AZ

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's CMS head confirmed, but FDA pick remains elusive ( Axios/Yahoo ) BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work ( Pink Sheet ) CDC: Half of US adults now vaccinated against COVID-19 ( The Hill ) Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections ( Pharma Tech ) The Vaccine Rollout Is Changing ...