classification and medical devices

The announcement from TIS re classification of VG as a medicine, not device, was a little vague. It referred to a "European Commission (EC) Medical Devices Group" vote.

I'm guessing this refers to the Medical Devices Expert Group on Borderline and Classification.
http://ec.europa.eu/health/medical-devices/documents/borderline/index_en.htm

This is one of the working groups under the EC Directorate General Health and Consumers.

One of the members of this group is John Worroll. He was the Regulatory Affairs Manager for BSI until Mar 2011. Another is Clare Headley, Regulatory Affairs Specialist at MHRA. Plus Steve Owen, MHRA Head of Devices Policy, European and Regulatory Affairs.

Awkward for them!

This working group has a number of publications that are of particular interest to us.

The "MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES" gives a lot of examples of classifications for products, including some that incorporate medicinal substances.
http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf

It seems to get down to whether (a)VG incorporates a medicinal product and (b) whether that medicinal product has an ancillary function within the device.

A good example is zinc cream for nappy rash. The zinc is considered a medicinal product because there is a pharmacological or metabolic function demonstrated. However, the cream also acts as a barrier, so the function of zinc is ancillary to a non-medicinal function. It is therefore a ClassIII Rule 13 medical device.

So.... does VG have a function that is non-medicinal, or is solely medicinal? That's probably the question that is causing all the angst across agencies.

Also worth reading is the guidance on clinical evidence. There is a wide range of acceptable clinical trial evidence. There is certainly no prescription for blind randomised controlled trials. It depends on the device and circumstances.

See AppC,
http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf