Changing the classification of a medical device

Hi All,

We manufacture a novel medical device that has achieved the CE mark in Europe classified as a IIb. However, whilst submitting this device in other countries it has become clear that it is in fact a lower risk device than originally thought, and could indeed be considered a class IIa in Europe. How would I go about amending this classification?

Your help with this will be very much appreciated.

Jo

 

Jo. Why would you want to amend the classification.
For that matter, what controls you have already put in place, would it also be amended. I guess not.
I would like to know what benefits you are getting out of this IIb to IIa change...

Joke: There has always been a confusion about to be or not to be ~~~~~

 

Hi Somashekar,

Some countries will register a medical device for sale on the strength of the CE mark alone, and this is always easier when the device is of a lower classification. Furthermore I have heard that in Saudi Arabia and Australia Class I, IIa, and Canada/Japan Class I and II products may be approved for sale prior to formal approval.

Jo

 

Hi Jo

At first I would review the classification decisions that were made against the rules in Annex IX to see why initially your device came out as a Class IIb and to see if the classification was carried out correctly. As your device is a Class IIb, it must have had a technical file review by a Notified Body prior to the CE mark being issued. Part of this review would have been related to the classification, so the assumption is they agreed with you.

If you think that the classification is wrong and the device is actually a IIa following carrying out the review, the first stage is to talk to your notified body explaining that you think the classification is incorrect and why. They will then review this and either agree to change the classification or not. If you are still not happy in the UK in can ask the MHRA for advice on what classification your product is in, but they would prefer you to talk to your notified body first.

Hope this helps.

Jon

 

Hi Jon,

Thank you for your reply.

I joined the company just after the device had received CE mark, and it had been classified under Annex IX rule 9 as it involves the administration of energy to the patient in a potentially hazardous way. During registration of the device in Canada and Japan it was highlighted that the energy is not administered in a "potentially hazardous way", especially as the device itself generates a very low current, at less than or equal to 10 uA, and the classification for these countries was subsequently lowered.

It is with this in mind that I would like to bring our European classification in line with other countries, I just wasn't sure who to approach first.

Jo

 

Your NB ... They matter and none other in such case

 

Hi Jo,

I agree that your NB should be your first stop in this.

Your comment about clearance in Australia sounds a little strange. The Australian system is very similar to the EU one, and class IIa devices are treated very much like class IIa devices in the EU. Clearance for class I devices is indeed much simpler (self-declaration, like in the EU) but I understand this is less relevant in your case.

Cheers,
Ronen.

 

Jo
I agree the NB should be your first stop.

Before you approach them you should have in place a good justification why the original classification was incorrect and why initial it was thought that energy was administered in a "potentially hazardous way", and this is now not the case. You should base this on a review of your risk assessment to justify the change.Remember that the NB has already agreed with your initial classification and they will need to defend the change in classification to the regulatory authorities who review them and are putting them under more scrutiny.

Jon

 

Thank you Jon,

I'm sure I can get enough information together to support the lower classification, especially as HealthCanada and PMDA are of the same opinion as us.

Jo