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Clinical data requirements - Changing a Class I Medical Device to Class II

MDD_QNA

Involved In Discussions
#1
We are working with a company who produces a regular device (lamp) which now has class I indication. We want to use this lamp as a medical device and make it into a class II (a or b) device. The claim is that the lamp which is an indoor lamp replicates daylight and operates in the same spectrum. My question is:
When we expand the medical claims, what is necessary from a clinical perspective? Can we rely on published literature solely?
Or do we need to do our own clinical trials?
Is it enough to show equivalence between the two spectrums (daylight and the spectrum the lamp operates on) technically?
Do you have any examples of devices who has used the support of other published reports?

Thanks!
 
Elsmar Forum Sponsor
#2
Your classification is dependent upon the medical purpose of your lamp.

Is it intended for therapeutic use? (Treatment of SAD; seasonal affective disorder). This would be Class IIa (Rule 9).

If it is for illumination purposes in the visible spectrum it is Class I (Rule 10).
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Can we rely on published literature solely?
Or do we need to do our own clinical trials?
There is no overwhelming requirement to conduct clinical trials. In some cases the clinical evidence / clinical evaluation may be purely literary.

Recently the clinical evaluation bar has been raised, when rev. 4 of the official MEDDEV guidance was released. The answer to your question is in there, and depends on the device's details and claims.
 

Kees Fremerij

Starting to get Involved
#4
What I read is that it is intended for illumination purposes only. Following the rules would say Class I according to rule 12:

Active diagnostic devices intended to illuminate the patient's body in the visible spectrum such as examination lights

The question is not: what classification you would prefer but where is the device classified in.
 

MDD_QNA

Involved In Discussions
#5
What I read is that it is intended for illumination purposes only. Following the rules would say Class I according to rule 12:

Active diagnostic devices intended to illuminate the patient's body in the visible spectrum such as examination lights

The question is not: what classification you would prefer but where is the device classified in.
It is a class I device now and because of the expanded medical claim, it will probably be a class IIa medical device.
 

dgrainger

Trusted Information Resource
#6
It will depend on your new claims but the requirement is given in Annex X:

1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:
— there is demonstration of equivalence of the device to the device to which the data relates, and
— the data adequately demonstrate compliance with the relevant essential requirements.
1.1.2. Or a critical evaluation of the results of all clinical investigations made.
1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1
and 1.1.2.

Unless you can show equivalence, you will need clinical data.
 
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