Class I Medical Device into a higher class (IIa or IIb)

MDD_QNA · Aug 31, 2016

Dear all,
What would be the reason to buy a product that is of class I and make it into a class II device? I have been asked to look into this matter. We have a pharmaceutical (lotion) that is used together with a lamp. This lamp is a class I device right now. And I am looking into what the requirements are to make it into a class II device.
Will the new regulation have any effect on the matter?
I have no idea about this lamp as for now.

Very grateful for your input!

Ronen E · Aug 31, 2016

Re: Class I into a higher class (IIa or IIb)

If a given device is classified properly, there is no way you can force-classify it into another class unless you change its design or its intended use.

What would your company gain from having the lamp classified as >1?

MDD_QNA · Aug 31, 2016

Ok, so the design will remain the same and we will add one indication to it. It will probably become a class IIa device, so what are the requirements compared to class I, when it comes to documentation?
Probably 60601-testing and EMC, particular 2-57, clinical data, IFU/label update. What else?

Edit: right now the lamp is used as an overhead lighting for surgery and it will have a new intended use of treating a disease.

mihzago · Aug 31, 2016

Clinical data is required for all classes, see MEDDEV 2.7/1 rev. 4.

You will also need a Notified Body involvement to review your tech file and issue the EC Cert.

there may be other things.

Ronen E · Aug 31, 2016

MDD_QNA said:
It will probably become a class IIa device, so what are the requirements compared to class I, when it comes to documentation?
Probably 60601-testing and EMC, particular 2-57, clinical data, IFU/label update. What else?

With all due respect, I think that your approach isn't right.

In the EU (which I assume is your regulatory context in this discussion) class I devices and class IIa devices are treated quite differently. My advice - forget that the lamp was ever classified as class I. Look at it as it is, with the newly added intended use, and analyse your regulatory situation accordingly. Study the relevant MDD requirements and verify that all are met. Some will already be covered as part of the class I compliance, but the gaps are likely to be significant.

Probably the biggest difference is the obligation to get a NB involved.

MDD_QNA · Sep 1, 2016

And how do we determine what annex to follow? A similar device we have we use Annex V and VII.

MDD_QNA · Sep 1, 2016

Ronen E said:
With all due respect, I think that your approach isn't right.

In the EU (which I assume is your regulatory context in this discussion) class I devices and class IIa devices are treated quite differently. My advice - forget that the lamp was ever classified as class I. Look at it as it is, with the newly added intended use, and analyse your regulatory situation accordingly. Study the relevant MDD requirements and verify that all are met. Some will already be covered as part of the class I compliance, but the gaps are likely to be significant.

Probably the biggest difference is the obligation to get a NB involved.

What is the GAP in terms of documentation? What is the difference in documentation requirement?

Ronen E · Sep 1, 2016

MDD_QNA said:
And how do we determine what annex to follow? A similar device we have we use Annex V and VII.

If indeed the lamp is classified as IIa, and you don't actually make it or physically change anything in it, you could probably do with Annex VI instead of Annex V (and it's a little less burdensome). You could, however, keep it under Annex V and exclude the parts that are not relevant.

Class I Medical Device into a higher class (IIa or IIb)

MDD_QNA

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Ronen E

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MDD_QNA

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mihzago

Ronen E

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MDD_QNA

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MDD_QNA

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Ronen E

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