Introduction - Medical Device Design: Innovation from Concept to Market - page 8

need to keep in constant touch with these important definitions; and the second is that we
need to keep up to date with advances in medicine and technology.
There are a number of other requirements you need to be aware of too. In medical devices
there are subdisciplines that you need to make sure you work with (EC, 1990 and 1998).
The first area is Active Implantable Devices (90/385/EC); within Europe this has its own
directive. The second area is In-Vitro Diagnostics (98/79/EC); again, in Europe this has its
own directive too. Your product may also fall foul of other directives, such as Electromagnetic
Compatibility (EMC) or even Powered Tools. Hence the rule here is have a copy of any
legislative document you may think you will need in hand; they are free to download from the
websites so there is no excuse. A list of important links can be found in Appendix A; however
you should make sure you keep your own list and keep it up to date as the documents change,
rapidly. Then, you can omit or include them in the design process, at your leisure. We will
be looking at this in more detail when we cover classiications - that is, putting your device
within the correct pigeonhole for regulatory requirements. In the end, as long as you do your
design work correctly the classification is immaterial, as a designer should treat every design
with the same care. However, it does influence some of your decisions.
It is important now to introduce you to the police forces of medical devices. It is worth
thinking of them as police because they have the power of life and death over your device and
your company.
In Europe each country has its own government body called the Competent Authority , as
presented before. Even though they are separate bodies they act as one so that an application
for a CE mark (the license to sell with the European Union) within one country counts in all
of the other member states. The process is somewhat confused by the next level called the
Notified Body ; these are legal entities who are licensed by the Competent Authority to do the
CE marking process. These are the people that an applicant would speak to and would be
audited by. This is completely different in the USA; here the body is the U.S. Food and Drugs
Administration (FDA) and the relevant subset is the Center for Devices and Radiological
Health (CDRH). The applicant talks directly to the FDA (via CDRH) and obtains a clearance
to market (DO NOT use any other words).
It is important to know that the applicant/holder of the CE mark or FDA clearance to market
is universally known as the manufacturer . They are the top of the regulatory food chain and
are ultimately responsible for the safety of said device; the designer, the subcontractor, the
packager, etc. are subservient to them. However, all are a part of the regulatory process (as we
will see later). With manufacturer status come levels of responsibility beyond just insurance
such as reporting, vigilance, postmarket surveillance, gathering clinical evidence , and much
more. Some levels are beyond the scope of this topic, but they will be referred to as necessary.