'Inadequate' change in diabetes device regulation will not protect patients

[Northerner]

The European Commission vote to approve new legislation, which would supposedly tighten medical device regulation and improve patient safety 'will not protect patients with diabetes', says the European Association for the Study of Diabetes (EASD).
The system used to approve medical devices in Europe is considerably less rigorous than that which is used to approve new pharmaceuticals, and is also less stringent than the process used in the USA.

To obtain consent for a medical device in Europe, manufacturers must be awarded the Conformit? Europ?enne (CE) stamp, which is overseen by a Notified Body (NB), often a private organisation operating under the authority of a 'competent authority' or regulator for the EU country in which they are based.

For example, in the case of a new blood glucose monitor a manufacturer must choose an NB in any country, to which it will pay relevant fees.

The duty of the Notified Body is then to ensure that the device meets required standards and specifications, and once approved it can be marketed across Europe with a CE approval mark.

However, Dr. Deborah Cohen, Investigations Editor at the British Medical Journal has found that this system is subject to various abuses.

http://www.theinformationdaily.com/...s-device-regulation-will-not-protect-patients

 

[Northerner]

This sounds very worrying I wonder if this is how all those cheap meters get their approval?

 

[trophywench]

Have a Roche one then, being Swiss one tends to think they ought to be rigorously tested and be A OK.

But of course they are most likely still made in Indonesia really - I know the expensive strips for one tried and trusted meter manufacturer and the cheapest strips on the market were coming off adjacent production lines in one Indonesian factory the day my own pharmacist visited on a guided tour a couple of years ago - cos he told me!