What this Division is about
41FA What this Division is about
Kinds of medical devices are usually included in the Register once an application is made, together with the required certification and the application passes preliminary assessment. However, applications may be selected for audit, which involves checking some or all aspects of the application and certification.
In some cases, an application relating to a kind of medical device will not pass preliminary assessment unless that kind of device is covered by a conformity assessment certificate under Part 4‑4: see paragraph 41FDB(2)(e).
Dealing in medical devices of a kind not included in the Register may be an offence or may contravene a civil penalty provision: see Division 3 of Part 4‑11.
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