CE Classification of a Medical Device

B

B_Ken

Hi all, and thanks in advance for your help.

We are developing a device which relieves pain using vibration. We met with three certification companies/consultants, and two of them said the device is class I, while one claimed it was class II for CE regulation.

When I checked the CE classification rules, I couldn't find any specifications on vibration. The Consultant who claimed it was Class II said it falls under Rule 9, because of the vibration and the therapeutic claim.

Is this correct? Or are the other consultants missing something?

Can anyone explain which rule does the device fall under, and why?

:thanx:
 
M

MIREGMGR

I'm not aware of a precedent or guidance that would point in a different direction than Rule 9. The "administer energy" and "therapeutic" characteristics are givens, so what justification do the other two consultants provide for their Class I conclusions?

I'd expect that as a part of your justification under Rule 9 you would be expected to show conclusive evidence that your device isn't hazardous, to avoid applicability of the IIb conditional clause.
 
S

SteveK

I checked out a number of pain relief items out there on the market that work through vibration, and they do seem to be all Class I devices (and battery powered) i.e. self-certification. The consultant indicating that they are Class II (Rule 9) was probably referencing MEDDEV 2. 4/1 Rev. 9. This indicates that ?muscle stimulators? are Class IIa. Usual issue with interpretation.

Steve
 
Ronen E

Ronen E

Problem Solver
Moderator
SteveK said:
I checked out a number of pain relief items out there on the market that work through vibration, and they do seem to be all Class I devices (and battery powered) i.e. self-certification. The consultant indicating that they are Class II (Rule 9) was probably referencing MEDDEV 2. 4/1 Rev. 9. This indicates that “muscle stimulators” are Class IIa. Usual issue with interpretation.

Steve
Click to expand...

Muscle stimulators are listed in MEDDEV 2.4/1 Rev. 9 in rule 9 under "Electrical and/or magnetic and electromagnetic energy". IMO pure vibration should have been listed under "Mechanical energy", so I guess MEDDEV 2.4/1 Rev. 9 is not likely to be a good reference. Regardless, my reading of rule 9 yields that vibration based pain relief devices cannot be class I, unless they receive the vibration from another device and just transfer it. I'm not aware of an efficient EC legal mechanism to weed out wrong class I registrations, so the fact that there are some similar devices registered in the EC as class I doesn't necessarily mean that that (self?) classification is valid.
 
B

B_Ken

Thanks all for the assistance and guidance. We are trying to figure out which way is better. I went through numerous resources of CE classfication, and couldn't find a decisive answer.

As mentioned - there are similar devices with Class I, so it is a possible route to go through. However, Its seems that vibration is energy, though not specifically stated in Rule 9.

The two consultants justify their classification by stating it doesn't fall under any rules for active devices, since it is only vibration - thus making it class I. In fact, we never questioned their decision until one of our distributors claimed this was not a class I device.

We are trying to avoid classification based on "interpretation" of MEDDEV 2.4/1 Rev. 9, so if anyone can point me to the exact place or reference to conclude the classification of the device I would appreciate it.
 
Ronen E

Ronen E

Problem Solver
Moderator
Physically speaking, a vibrating device in direct contact with the patient is transferring energy (kinetic energy), thus it is an active device, assuming the vibration is generated in the device itself (e.g. from electricity). "Vibration" is just a reciprocal movement in a relatively high frequency. Calling it "just vibration" can't change the physics of the situation.
 
M

MIREGMGR

Ronen E said:
Calling it "just vibration" can't change the physics of the situation.
Click to expand...

Agreed. The classification rules, like all regulatory writings in my experience, assume interpretation by someone with an education that includes classical physics, to understand the words used in the intended ways.
 
CharlieUK

CharlieUK

Quite Involved in Discussions
http://www.mhra.gov.uk/Howweregulate/Devices/Classification/
Disagreements on classification
It is for the manufacturer to initially determine the classification of their product(s). This will allow them to select a notified body (if required) with the ability to carry out the appropriate conformity assessment procedure. It will then be for that notified body to confirm the classification arrived at by the manufacturer before embarking upon the process of conformity assessment.
In the event that the manufacturer and the notified body cannot agree on the classification, either party can refer the matter for a decision to the competent authority that designated the notified body

To be honest, without FULL details of your product I doubt you'll be able to get a completely satisfactory opinion from here (and that's no disrespect to the posters).
Possibly worth bearing in mind that Medical Devices are somewhat on the radar of market surveillance at the minute, what with the PIP Implant issue and a recent Market Surveillance activity in which several NBs gave positive opinion for the use of a string fruit bag (e.g. for oranges or lemons) as an Abdominal Mesh!!

I would suggest that unless you can clearly demonstrate Class I, then go for Class IIa, or seek opinion from your local equivalent of the MHRA.
 
L

Leetcc

Hi All,
I have a question relating to CE Marking. If a medical device has been CE Marked does that mean it must also be REACH (155) compliant?
 
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