• 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...
  • 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

    MDCG clarifies remote audit expectations for notified bodies

    The European Commission’s Medical Device Coordination Group (MDCG) released a new questions and answers document clarifying expectations for notified bodies looking to conduct remote audits of medical device manufacturers during the COVID-19 pandemic.   The document is meant to answer “operational and practical implementation” questions raised in response to the committee’s MDCG 2020-4 guidance released in the early months of the pandemic. (RELATED: Notified body aud...
  • Feature ArticlesFeature Articles

    September’s Regulatory Focus: Countdown to EU MDR and IVDR

    Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.   MDR and IVDR, close up Full implementation of MDR is slated for ne...
  • Feature ArticlesFeature Articles

    Implementing the MDR: Slowing down on the homestretch?

    With the most recent delay to 26 May 2021 as the date of application for the European Union Medical Device Regulation (MDR) 1 still fresh in our minds, 2 many wonder if it is a matter of time before we hear about the next extension. It’s a valid question, as many manufacturers still have a long way to go until they are fully compliant with the new rules and expectations. However, it does not do justice to the differences between the circumstances at the start of the firs...
  • Regulatory NewsRegulatory News

    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...
  • Regulatory NewsRegulatory News

    Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline

    European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues. According to the European Association for Medical Devices of Notified Bodies (Team-NB), 84% of notified bodies intend to submit their application in November, 8% intend to submit in December and 8% next year. More than half of the no...
  • Regulatory NewsRegulatory News

    EU Court of Justice Clarifies Product Liability for Notified Bodies

    The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives. But the court's decision was more about clarifying the role of notified bodies in a product liability case concerning faulty breast implants made by the now-defunct French manufacturer Poly Implant Prothese (PIP) and German notified body TÜV Rheinland than about deciding if the notified body was liable....
  • Regulatory NewsRegulatory News

    EMA Weighs New Guideline on Quality Requirements for Combination Products

    The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. EMA says the guideline will consider the data requirements with respect to quality aspects in relation to the safety and performance of the medical device, whether it is an integral component of the medicinal product or a stan...
  • Regulatory NewsRegulatory News

    MHRA Looks to Increase Medical Device Fees

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies. While the agency noted some concerns over the increased costs associated with the fees, it said that the "majority of respondents were content with the fee changes proposed." Last April, MHRA released its business plan for 2016-2017, warning of serious financial troubles for ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (5 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Clarifies Stance on EC Certificates for Devices The Swiss Agency for Therapeutic Products (Swissmedic) has given medical device manufacturers affected by the fall in the number of notified bodies one year to restore the legal conformity of their products. Swissmedic’s approach to the situation follows the harmonized procedure adopted by the European Union. ...