Obtaining Regulatory Approval to Market - Medical Device Design: Innovation from Concept to Market - page 308

CHAPTER 14
Obtaining Regulatory Approval to Market
14.1 Introduction
I can hear your sighs of relief! At last we have arrived at the zenith: the time of regulatory
approval. Just as a reminder, in the EC this is obtaining a CE mark; in the USA this is obtaining
an FDA clearance to market. In other countries, such as India, Australia, Canada, and Japan
for example, they have their own terminology. However, in all cases you are not allowed to sell
your device in said country unless you have the clearance/approval to do so. In this chapter we
shall concentrate on the EC (using the UK as the base) and USA application processes. Once
you have understood these, the extension to any remaining countries is a small conceptual leap.
14.2 Class I Devices
In previous chapters we saw the classification process. The obvious starting point for all
applications is the confirmation of the device's classification. The easiest classification of all
is Class I, or in FDA speak “510(k) exempt.” All manufacturers of medical devices need to be
registered, and this is the sole requirement for both the EC and the FDA.
14.2.1 EC Application
As stated earlier, this is going to be based around applying using the UK as the administrative
base - if you were to use Germany, for example, the process is similar but the forms will be
different. The first port of call is to identify the competent authority in the relevant country; in
the UK this is the MHRA (see Appendix A for other EC countries). The MHRA has a guidance
document for Class I manufacturers ( MHRA, 2006 ) - they also have a guidance document for the
actual registration process ( MHRA, 2008 ). These will help you to identify your commitments.
The form you will need is called “Medical Devices Regulations 2002: Regulations 19 and
30 form RG2. ” The form is simple to complete. There is only one form per company: it is not
a case of one form per product! Before you start you will need to download the document
called “Appendix A and B” ( MHRA, 2008 ).
This document contains a list of all items not considered to be medical devices. It lists
existing medical device groups and allocates them a Class I Generic Family Group Code. For
your benefit I have summarized the codes in Appendix D; however ensure you download the
latest guidance as these codes may change.