Notification of Changes to a Class I Medical Device - Reporting Requirements

[neash83]

Hello,

I'm trying to find any guidance on requirements related to notification of changes in a medical device.

It is only for a Class I device (non sterile and non measuring) done under Annex VII.

If there was a change made to the device, what requirements would apply regarding notification of change and to what type of changes?

I can't seem to find anything specific in the MDD and wondered if there was any guidance documents available specifically cover Class I devices?

Thanks

 

[dgrainger]

Re: Notification of Changes to Class I Medical Device Reporting Requirements

If it is a change to "reduce a risk of death or serious deterioration in the state of health" then you need to look at MEDDEV 2.12-1.

http://ec.europa.eu/growth/sectors/medical-devices/guidance_en

 

[neash83]

Re: Notification of Changes to Class I Medical Device Reporting Requirements

I was thinking more along the lines of more standard changes to the device, as opposed to those required under vigilance assessment. Such as a change in the material for performance requirements or indications for use.

Thanks

 

[pkost]

Re: Notification of Changes to Class I Medical Device Reporting Requirements

Notification of class I product is dependent on the competent authority

If you take the UK for example, the MHRA only expects you to inform them that you are placing a product group on the market; if you add to the group at a later date then you don't need to do anything (even if it is an entirely new device)

Other countries have different rules

 

[shimonv]

Re: Notification of Changes to Class I Medical Device Reporting Requirements

My understanding of it is that class I devices are self declaration.
So, as long your change is within the scope of the its definition as class I device, and as long as no adverse events or recalls are issued (which should't really happen with a low risk device), and as long as post-market surveialance information does't reveal something surprising that may change its classification - you are good.

I too, am not aware of any regulation on this matter.
It's important to make sure that your change control process includes regulatory assessment. This way if there is a change in the intended use someone will check if the classification remains the same.


Shimon