CE Mark unapproved Medical Devices - Ear wax removal

[Welshgar]

Hello, I am new to the forums and am a practicing private Audiologist.

I need to know the legal and personal implications of using/buying medical equipment in the UK that is not CE certified and not approved by the manufacturer for this particular process?

Many audiologists in the UK are now using suction machines designed for medical use in operations etc, but not to carry out cerumen(earwax) removal. There are no CE certified units available in the UK and manufacturers will not approve units designed for other suction uses as suitable.

The suction units for wax removal would probably be the same unit if approved, maybe with small modifications, but as yet no manufacturer will approve.

 

[Sidney Vianna]

Re: CE approved medical devices - ear wax removal

I need to know the legal and personal implications of using/buying medical equipment in the UK that is not CE certified and not approved by the manufacturer for this particular process?

I am no expert and hope someone with the knowledge will answer your question, in an authoritative manner, but I think the enforcement typically happens on the organization placing the device in the market, not the users.

In the case of a physician acquiring the device knowingly it's regulatory noncompliance, s/he might be subject to liability, provided someone informs the authorities, but I doubt the typical patient would ask questions to the doctor about the device being CE-marked, or not.

 

[MIREGMGR]

Re: CE Mark approved Medical Devices - Ear wax removal

From the MHRA guidance page to which Ronen's link points:

The patient must be fully informed during the consent procedure and a note made in their records if a device is going to be used off-label.

The guidance is carefully worded as a series of recommendations right up to the above sentence, when the requirement suddenly becomes mandatory.

Was this a drafting error by MHRA, or does their legal mandate provide that they can demand the above actions?

 

[pkost]

Re: CE Mark approved Medical Devices - Ear wax removal

I don't believe this is within the scope of MHRA's activities, although I think it is the DoH that would regulate this area (MHRA is part of DoH). regardless of this I would consider it sound advice if the patient consent lectures I have received are anything to go by

As an aside, there have been a number of device alerts and press releases directed at Dentists highlighting a large number of non CE marked devices being used and seized.
http ://www .mhra .gov. uk/NewsCentre/Pressreleases/CON181209
http ://www. mhra .gov. uk/NewsCentre/Pressreleases/CON467364
http :// www .mhra. gov. uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON369252?tabName=England

DEAD LINKS REMOVED.