In the blog

  • FDA commissions review of the 510(k) process

    Very interested to read recently that the FDA has commissioned the US Institute of Medicine (IOM) to review the 510(k) process. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm Whilst the review isn’t due to be complete until March 2011 I’ve already seen several articles from industry associations defending the current process. As part of the IOM there will be two public [...]

  • BSI acquires German Notified Body

    BSI has acquired German based Notified Body EUROCAT. EUROCAT is accredited for the certification of devices, IVD’s and active implantable’s and also offers product testing. See the official BSI press release here .

  • BSI adds to Fast Track service offering

    BSI has added a new accelerated programme for device manufacturers (CE-Dedicated Fast Track) looking to bring their product to market quickly.
    CE-Dedicated FastTrack offers reviews within 45 working days or less and does this by dedicating a reviewer to the project and by performing the review off-site. This is the 4th  such initiative BSI have introduced [...]

Reimbursement

Is your device CE marked but you are struggling to increase sales?
Do you understand the reimbursement mechanism in the UK?
What is the Drug Tariff?
Do you need help gaining reimbursement in Germany?

We note that (unlike medical device regulation) there is no pan-European process for medical device reimbursement.  Most countries use a system of diagnosis related groups (DRGs) to set a price for a particular medical procedure (including any products that will be used in that procedure).  The authorities use health technology assessment (HTA) to decide which products will be formally approved for use in the procedure, ensuring that only those products shown to be clinically and economically effective are reimbursed.  However, the decision concerning which products will be reimbursed (and often also what price will be paid) by the government or patient’s health insurance provider is driven by local government health care policy.  As such, there can be considerable variation in the reimbursement approval process (and data requirements) between different countries.  Additionally, the processes can be subject to regular change, as countries reform their respective health-care systems and budgets in line with their current policies.

We have experience of the reimbursement systems in the following countries:

  • United Kingdom & Republic of Ireland
  • France
  • Germany
  • Italy
  • Spain
  • Belgium
  • Holland
  • Switzerland
  • Austria
  • Greece*
  • Nordic region – Norway, Sweden, Finland*
  • Central and Eastern Europe – Czech Republic and Poland*

* Note:  We do not have personnel with a native language capability in these countries.