• Regulatory NewsRegulatory News

    First MDR Certificate Issued for Class III Device

    Notified body TÜV SÜD announced Thursday that it has issued the first Medical Devices Regulation (MDR) certificate for one of Germany-based Biotronik’s Class III (highest-risk category) medical devices, in addition to its quality management system. The newly certified device is Biotronik’s Renamic programmer software , which enables physicians to program and test implanted cardiac devices such as pacemakers, implantable cardioverter-defibrillators and cardiac resynchro...
  • 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....
  • Feature ArticlesFeature Articles

    Health Canada to Regulate Reprocessors of Single Use Medical Devices as Manufacturers

    This article explains reasons for reprocessing Single Use Devices (SUDs), major concerns about this practice and the potential impact of these new requirements. For the past several years, the Canadian medical devices industry has opposed reprocessing SUDs strongly, mainly because of unknown safety procedures, although this practice commonly is used in hospitals and by third-party service companies. The Reuse of Single Use Devices Task Force within Canada's medical tec...
  • Regulatory NewsRegulatory News

    Are Notified Bodies Responsible for the Failure of Companies They Oversee?

    A legal battle in Germany to determine responsibility in the aftermath of the Poly Implant Prothese (PIP) breast implant scandal will be put on hold while a German court asks for clarification from the European Court of Justice (ECJ), Deutsche Welle reports. Background For many years, PIP was one of the largest producers of silicone breast implants. However, after it came to light that the company used industrial-grade silicone in its implants, the company shut ...