Class Im auto-certificate or not

Hello:

In my company we are developing a medical device similar like an aberrometer. We after read a lot of times the MDD 93/42/ECC we thought that our device will be a class I with measuring function.

So, we started the electric and mechanical tests for ISO 60601-1 with SGS as notified body. SGS did inform us that we need to audit the ISO 13485 and the technical file, and in that way we can get the CE mark with the number of the agency.

But we did contact with TÜV too, and they suggest that we can auto-certificate the technical file.

Our dude is what is the correct way? The final CE mark is the same in both ways? I doubt it.
And the last one is, for the AEMPS, the CE mark obtained with auto-certificate is valid to obtain the manufacturing license?

Thank you.

 

It is very simple, if the device is classed as Im then you need to have a QMS in place i.e. to ISO 13485 and be audited to this and the MDD 92/43/EEC by a NB. Also you must submit a Technical File for it to be approved by the NB; then you can affix a CE Mark with their number. Maybe TUV misunderstood and thought it was just a class I device (i.e. without a measuring function – therefore auto-certification).
As to the actual classification I would just check MEDDEV 2. 4/1 Rev. 9 as well because I have seen these devices classified as IIa (see as an example - http://www.imagine-eyes.com/wp-content/uploads/2014/08/M-DCP-001-g-irx3-datasheet.pdf). This is a bit academic though, as regardless if Im or IIa what I have indicated still applies.
Steve

 

Thank you. We supposed the same.

Yes, is correct that previous similar products like the IRx3 was classified as class IIa, but I think that now SGS we recommend to use the class Im because the energy used is thousand time lower than limits.

 

There's a difference in the conformity assessment route between class I/m and IIa.

In class IIa the NB's intervention covers all relevant aspects, while in class I/m it's only supposed to cover the aspects of manufacture concerned with the conformity of the products with the metrological requirements.

 

Hello Ronen E,

What do you mean exactly with the differents between intervention on class Im and IIa ?

Thank you

 

Hi,

The MDD stipulates the process of NB intervention (certification) for devices in classes IIa, IIb and III. The details are too many to reproduce here, and anyway they depend on the case specifics and sometimes on the manufacturer's elections of conformity assessment route (i.e. what annex to follow). It's all in the MDD text.

For class I (non sterile and no measuring function) NB certification is not required, so the related requirements are void.

Class I/m (class I with a measuring function) and class I/s (class I sterile) are somewhere in between these two categories. They do require NB involvement, but the scope / extent is more limited. In my previous post I quoted the general description of the nature of NB involvement for class I/m devices.

Please note that officially there are no "class I/m" and "class I/s", it's just a jargon we use. Such devices fall in class I, with some exceptions spelled out for these special cases.

Cheers,
Ronen.

 

Thank you for your response.
We just on the middle on our certification with SGS company, we are in the middle of mechanical and security tests. We already passed the electrical testing.

All the mess came up when they tall us this last winter, they have too many project that maybe the date set for our audit is delayed and we just trying to find another possibilities for NB.

Then, TUV tall us a different version for acquire the CE mark, they suggest us to make the auto-certificate.

Actually we decide to follow the Annex 4 of MDD.

 

The first, and most important, thing is to determine and validate the device true classification. It is the manufacturer's responsibility, and in cases where a NB is involved the NB is expected to initially assess the manufacturer's classification during the quoting and engagement phase, and later to ascertain it during the Technical File assessment.

In your case the classification is apparently either I/m or IIa - in both cases a NB involvement is required, so any NB involved ought to have already determined the right classification. We can't do it because we don't have access to all the relevant device details. We can currently only speculate.

Your statement regarding following Annex IV indicates that the device was classified in class IIa. Class I/m would not require Annex IV.

If you are certain that you have classified the device correctly, you should communicate your considerations with TUV (assuming you want to work with them), and either get them to concur or explain why your classification is mistaken. If they insist that it's a class I device perhaps you should explain that it is a measuring device and as such a NB involvement is required. Hopefully they will then provide you a quote for certification, either adopting a I/m classification or accepting your IIa classification. One way or another, they will have to address it during quoting because there's a significant difference in their scope between these two classifications.

Cheers,
Ronen.

 

Both NB (SGS and TUV) tell us that our product is a class Im, and we follow the Annex IV according with the directive indications.


This flow chart shows that if the medical device has a measuring function, you can follow annex IV, V or VI.
My boss tell me that we have finally follow the annex IV choosing the "Statistical verification".

 

Please note that that flowchart is not taken from the MDD. It is someone's interpretation / summary of requirements from the MDD.

To put things straight, by the MDD a class I/m device manufacturer can follow either annex II, IV, V, VI (not just IV, V, or VI), but needs to do so only in relation to the aspects of manufacture concerned with the conformity of the products with the metrological requirements. The NB's intervention should be limited to the same extent as well. In some cases this could make a big difference.

Further, in my opinion annex IV would not normally be the preferred path. Annex V or VI may be easier to implement and provide more flexibility. A careful analysis is necessary in each case.

Cheers,
Ronen.