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Medical devices Examples of common appliances with a CE
mark and listed in the Drug Tariff are:
The easiest way to tell the difference between
medicinal products and medical devices is to • Micropore Tape
look for a CE mark which
signifies that the item is • Aknicare Lotion and Aknicare Cream
registered as a device. The • Bug Buster Kit
CE mark can normally be
found on the packaging • Appeel Medical Adhesive Remover
of a device, on the instruction leaflet and Examples of appliances with a CE mark and
sometimes on the device itself.
not listed in the Drug Tariff are:
What is the CE mark and how does it
affect us in pharmacy? • NeilMed Sinus Rinse
• Tena Pad
A CE mark needs to be applied to a medical
device so that it can be marketed in Europe. Never assume that a product is a medicine:
The mark is applied by the manufacturer. The you may think it is a medicine – but it could
CE mark itself means numerous things. be a device.
It means firstly that the device itself has met A good example of this is sodium bicarbonate
the required standards; it is safe and works as 5% ear drops - you may automatically think
it should do. This is verified by an Independent of this as a medicine but it’s a device and is
Certification body (Notified Body). The MHRA listed in part IXA of the Drug Tariff. Carmellose
is responsible for appointing the UK Notified 0.5% unit dose vials, sodium chloride 5%
Bodies and to make sure they perform to high eye drops, and Lumecare Advance 0.5%
standards. The MHRA regularly audits these eye drops, are all similar examples of items
notified bodies to make sure that this is the classed as devices rather than as medicinal
case. products.
So how does the CE mark affect us? A useful resource for checking if you will
be paid for an appliance is the PSNC's
The CE mark denotes that the product is
a registered medical advice and devices "Dispensing on an FP10 database". This
can only be supplied if they are specifically provides information on commonly queried
named, including the pack size, in the medicinal products and appliances, as well
appliance sections of the Drug Tariff, parts IX as some supplements, foods, toiletries and
A, B, C and R. cosmetics.
Finally, if a product does not have a CE mark
If you have the product in stock, you can then it is either a medicinal product, a food/
easily check the packaging to see if it has nutritional supplement or a cosmetic/toiletry.
a CE mark – but what to do if you do not
have sight of the product itself? There are Medicinal products
a number of ways to check if a product is
registered as a device: The Drug Tariff contains an extensive list
of medicines along with the price that a
• Check the Dictionary of Medicines and pharmacy will be paid for dispensing on
Devices (DMD): this online resource gives prescription. This list is called Part VIIIA
details of the vast majority of healthcare and the medicines are split into different
products and will specify if a product is categories based on availability. The
registered as a device or a medicine. categories are not important for our purposes;
the point is that if a drug is listed in the DT
• Check the manufacturer’s product then you will be reimbursed the set price for
website or contact the manufacturer for dispensing it.
clarification.
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