Obtaining Regulatory Approval to Market - Medical Device Design: Innovation from Concept to Market - page 320

Once again ask around. You will not be able to obtain medical devices cover from your
high street insurance broker: it is a specialist field. Asking questions should never cause
embarrassment.
14.7 Summary
We have met the self-certification process of the EC and the FDA for Class I and 510(k)
exempt devices. We saw that the declaration we make means that we cannot avoid having a
controlled design process - and that to do otherwise is highly risky. We saw that this was the
simplest route to market but is limited to the most simple of medical devices.
We subsequently saw that the FDA and EC process diverts for higher classification devices
and we were introduced to the 510(k) application process and the CE mark audit process. We
recognized the need for advisors, especially when applying for the first time, and we also saw
that it was an annual process.
We also saw how our design process has helped us to help our sales staff. We will have
developed USPs, found key opinion leaders, and produced evidence that they can use to
persuade the most hardened of purchasing officers.
References
FDA (2012). Who must register, list and pay the fee. < www.fda.gov > .
FDA (2005). Guidance for industry and FDA staff: Format for traditional and abbreviated 510(k)s . FDA.
MHRA (2006). Guidance notes for manufacturers of Class I medical devices, no 7 . MHRA.
MHRA (2008). Guidance notes for the registration of persons responsible for placing devices on the market, no 8 .
MHRA.
MHRA (2008). Appendix A and B . MHRA.