• 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...
  • RoundupsRoundups

    Euro Roundup: MHRA contemplates a new regulatory framework for personalized medicines

    MHRA seeks feedback on making personalized medicines at the point of care   The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.   In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distrib...
  • 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...
  • 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

    EU IVDR compliance in a small organization

    This article presents a brief overview of the EU In Vitro Diagnostic Regulation (IVDR) requirements. It provides a user-friendly, step-by-step guide on how to comply with the regulation from first-hand experience and includes suggestions and tips for IVDR compliance through the lens of a small organization.   Understanding the changes of EU IVDR The IVDR, or Regulation 2017/746, 1 on in vitro diagnostics (IVDs) came into effect with its publication on 26 May 2017 ...
  • Regulatory NewsRegulatory News

    IVDR: MDCG charts rollout in new implementation plan

    The European Commission’s Medical Device Coordination Group (MDCG) this week released its joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR) set to take effect next May.   With the date of application of the Medical Devices Regulation (MDR) now in the rear view, MDCG’s attention is turned to challenges on the horizon related to IVDR. MDCG previously released a joint implementation plan for MDR in March 2020, bef...
  • 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

    Industry and patient groups call for IVDR delay

    In the wake of the 26 May EU implementation of the new medical device Regulation (MDR), a trade group, a patient association and a data analytics firm have jointly called for a delay in implementation of the parallel In Vitro Diagnostics Regulation (IVDR), now slated for 26 May 2022. Without a course correction, the organizations cite the potential for serious disruptions in patient care, especially in targeted therapies for cancer patients.   With just a year to go ...
  • Feature ArticlesFeature Articles

    EU IVDR countdown: Opportunities await, but concerns linger over notified bodies

    It is essential for manufacturers of in vitro diagnostics (IVDs) to understand the full scope of changes under the May 2022 In Vitro Diagnostic Regulation (IVDR) to ensure compliance with the new regulations and seamless placement and maintenance of safe, effective products on the EU market and streamline access to the larger global market. One note of caution, however, is that EU-certified IVDR notified bodies (NBs) are overwhelmed with product review applications and tim...
  • 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...
  • Regulatory NewsRegulatory News

    Euro Convergence: Regulators and industry seek ‘sparks’ of European change

    The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.   The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representati...