• Regulatory NewsRegulatory News

    A Step Forward for New EU Medical Device Legislation

    After weeks of heightened speculation, the European Council has agreed on its approach to new medical devices and in vitro diagnostics (IVD) legislation. Background Regulators in Europe have been discussing the need to reform the legislative framework for medical devices and IVD for many years. In the EU, the legislative process is structured so that only the EC can initiate new legislation. The European Parliament then votes on the commission's proposal and legisl...
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    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 ...
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    EU Notified Bodies Update Code of Conduct

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The European Association for Medical Devices of Notified Bodies (Team-NB) has published an updated Code of Conduct targeting more consistent and transparent CE Mark certifications from member firms. First implemented by Team-NB in early 2013, the Code of Conduct’s version 3.2 makes more explicit processes and procedures Notified B...
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    Australian TGA Taking a More Discerning Approach to Notified Bodies

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits  for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used the...
  • MHRA Releases IVD Guidance for Notified Bodies

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guidance for notified bodies pertaining to the regulation of in vitro diagnostic (IVD) products used in home healthcare settings for self-testing. Assuring the safe use of these products is a challenge, the agency notes, as there is unlikely to be a healthcare professional present to guide the patient in the proper use of the device or the correct interpretation of its results. "It i...