• 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....
  • 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 ...