Biomedical Engineering Reference
In-Depth Information
CASE STUDY 14.1
A company wishes to sell its new peak flow meters in the EC. Identify the generic code it
should adopt.
Appendix D gives this as a Diagnostic Device (Letter C) with a specific code C3.
CASE STUDY 14.2
A new company has developed a new device that requires a packed set of dressings to be used in
the operating theater. Identify the generic code.
Appendix D illustrates two answers. If the dressings are individual then their code would be D3.
If, however, the dressings are supplied as a pack for a particular procedure then this could fall
under code L2. The obvious answer is to register for both, but note that you must comply with
any further regulations required for System and Procedure Packs.
CASE STUDY 14.3
An established UK company is to act as the representative for a USA-based company in the EC.
Identify the information required for form RG2.
The authorized representative's name and address is entered into the “UK Address” section in
Part 2. The USA manufacturer's name and address is entered into the “Manufacturer's Address
if outside the EC” in Part 2. Note that PO Box numbers are not allowed.
The USA company's product range is listed as Codes and Product Names in Part 4.
The process for registration is similar in all EC countries; you just need to decide which country
is to be your “home base.” More often than not that decision is driven by the following:
l
Market dominance
l
Native language
l
Your EC representative's address
For more information, the competent authority's contact details are given in Appendix A.
Once your registration form is complete you send it to the competent authority, with fee
enclosed, and await the reply. You should receive a confirmation letter with your company
registration number within a few months. This confirmation letter is your approval to market
your registered devices in the whole of the EC.
Some of you may be asking, “If this is all that is required, why did we need to go through the
previous 13 chapters?” Even though you have self-certified, you have actually self-certified
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