Document paper New medtech regulations

Links to relevant articles (15 June – 15 July 2017)


  • ESIP and AIM (European Payer associations) met with DG SANTE (link to minutes)
  • Assessing the economic costs of unhealthy diets and low physical activity: an evidence review and proposed framework by WHO (link)
  • NHS Diabetes Prevention Programme is expanding in England (link)
  • Deloitte – 21st Century Cures: The Future of Product Innovation and Approval (link)
  • New EU-Japan deal ‘presents opportunities for Irish exporters’ (link)
  • Manufacturing costs and a challenging NHS chief concerns for UK medtech (link)
  • First aid for medtech players targeting the US export market (link)
  • Computer-Simulated Tests Eyed at FDA to Cut Drug Approval Costs (link)
  • Call for proposals for 2018 work program of the Belgian Health Care Knowledge Centre (link)
  • Call for submissions for Innovation and Technology Tariff in England (link)
  • Five new procedure and nine diagnostic codes were added to private reimbursement schedule in England in May (link)
  • England is making further step towards integrated health and social care system (link)
  • Medical technology IVD-related technology assessments from NICE in June 2017
    • Neo Pedicle Screw System (a set of single use instruments and implantable screws and rods used for spinal fusion surgery in adults) – link
    • SecurAcath (device for securing cerebrospinal fluid drainage catheters, which uses a small metal ‘anchor’ that sits below the skin and holds the catheter in place)- link
    • Head injury: assessment and early management (link)
    • Spondyloarthritis in over 16s: diagnosis and management (link)
    • RIDASCREEN (tests for monitoring infliximab in inflammatory bowel disease) – link
    • Four Interventional Procedure Guidance for treatment of vaginal vault prolapse and uterine prolapse:
    • Multiple frequency bioimpedance devices to guide fluid management in people with chronic kidney disease having dialysis link
    • Italian Ministry of Health has opened a 60-days public consultation for 5 new health technology assessments of medical technologies (link)
      • Medical devices for treatment-resistant hypertension
      • Next Generation Sequencing (NGS)
      • Chirurgia robotica
      • Sling operation for urinary incontinence in women and men
      • Protesizzazione del disco intervertebrale cervicale e lombare
    • Care Institute Netherlands (Zorginstituut Nederland) is evaluating baroreflex activation therapy for inclusion into basic insurance package (link)

Posted on 17.07.2017

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