Obtaining Regulatory Approval to Market - Medical Device Design: Innovation from Concept to Market - page 316

Do not expect this process to be quick. The higher the classification, the more detailed
the inspection. The process can take a few weeks from receipt to several months,
even years.
Eventually, and with luck, you will receive a confirmation letter that you have clearance
to market ( not approval). This letter will contain your 510(k) registration number and the
registration will be added to your company's electronic record. Remember to renew your
FDA registration every year or your 510(k) lapses.
14.4.4 Effect on IP
The USA has recognized the impact of the regulatory process on the life of a patent. Hence
it is possible to claim for a PTE (Patent Term Extension). But this will be dependent on your
patent agent successfully claiming the regulatory process has impacted on your patent's
life. The duration of the extension is also dependent on your patent agent's arguments.
Unfortunately there is no such provision in the EC for medical devices.
14.5 EC Process
Unfortunately the EC process is more difficult as it is based on an audit of your procedures.
Unlike the FDA where you need to prove the device, the EC process is to prove that you have
procedures in place that enable you to design, make, and sell a safe medical device, and that
you adhere to them.
The process is to identify a notified body (the next level down from the competent authority)
who has a license to audit a company to EC 93/42/EC and/or ISO 13485. In order to be
able to attach a CE mark to your device, you must have the 93/42/EC certificate. There is a
plethora of accreditation bodies that can perform this task and their costs and helpfulness
vary. The best advice here is to ask around and find out what other establishments
recommend: there is no more credit to obtaining a certificate from an expensive group - it is
still a certificate.
The audit itself will take 1-2 days. This will be the most intense two days you will have all
year. However, be prepared to spend the preceding week(s) preparing for the visit. When
they arrive do not be gladiatorial; this does not help. However, do be prepared to stand your
ground if you feel it necessary as they are not experts in every field of medicine.
14.5.1 Advice
Unlike the FDA, the body you ask to audit your company is not allowed to give advice;
this is against the rules. It is therefore necessary to seek advice, from an early stage, from
an “independent advisor.” The costs and level of expertise vary with the tides. Once again,
ask around and interview advisors. It is strongly suggested that unless you are a highly