Rob Higgins is a Senior Regulatory Affairs Specialist at the Medicines and Healthcare products Regulatory Agency (MHRA). He has been with the Agency and its predecessors for more than 35 years. Previously he headed up the team working in the area of medical device regulation including the review of clinical investigation applications, medical device registration, designation and monitoring of Notified Bodies (third party organizations who carry out assessments of medical device manufacturers and devices) and technical interpretations, including borderline issues.  His main current responsibilities include direct manufacturer audits, assessments of UK Approved Bodies as well as involvement in the Medical Device Single Audit Program (MDSAP) and the International Medical Devices Regulators Forum (IMDRF).