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Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.

European Internet of Things Cybersecurity Recommendations: Impact for Medical Devices


  • European regulators have published high-level cybersecurity recommendations for industries including medical devices involved in the Internet of Things (IoT) paradigm.
  • The recommendations are partially intended to help companies meet upcoming European data privacy requirements under the General Data Protection Regulation, or GDPR.
  • The European report cites US FDA guidance regarding medical device cybersecurity principles and recommendations.

Five Reasons for Receiving an FDA Refuse-to-Accept (RTA) Decision on your 510(k) Registration


  • FDA 510(k) applicants may receive Refuse to Accept (RTA) letters if their submissions are not complete, delaying their medical device clearance reviews.
  • Meeting RTA screening criteria can help medical device registrants avoid receiving RTA letters from FDA reviewers.
  • Utilizing the FDA Pre-Submission (Pre-Sub) program prior to submitting 510(k) applications may also minimize the risk of clearance delays due to RTA issues.



  • 欧洲、英国和世界其他地区的所有经济运营者都将面临英国脱欧所带来的重大影响。
  • 我们需要对目前由英国通过进口商投放到市场上的医疗器械经销网络重新进行审视。
  • 目前将英国制造商的医疗器械投放到市场上的欧盟经销商们可能要开始扮演一个不同的角色。
  • 除非达成合适的协议,否则由英国公证机构根据欧盟监管法规/指令签发的所有证书从2019年3月开始就将失效。
  • 公证机构已经预期这种情景将会发生。

Brexit: The Hard Reality of “No Deal” for the Medical Device Industry


  • All economic operators in Europe, the UK and in the rest of the world may face significant consequences of Brexit.
  • The distribution network of medical devices currently placed on the market by UK based importers must be reviewed.
  • EU distributors currently placing UK manufactured devices on the market may have a different role.
  • Unless a fitting deal has been made, all certificates issued by British Notified Bodies on EU regulations/directives will become void from 30 March 2019.
  • Notified Bodies are already anticipating this scenario.