Validation of a change to a CE Marked Medical Device

JoCam

Trusted Information Resource
Hello,

A quick question about validation requirements for a change to a CE marked electrical device.

The electrical device in question is a Class 11b, and at present is battery powered. The mains powered battery recharging station supplied, together with the battery powered device have both been electrically tested.

We are looking to replace the battery system and move across to mains powered adaptor. Whilst we can see numerous requirements for verification of this change, are there any requirements for validation? We fully validated the battery powered device (with mains adaptor charging station) to obtain the CE mark, would we be expected to repeat all this validation as a result of this change?

Your help with this will be very much appreciated.

Regards,

Jo
 
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mihzago

Trusted Information Resource
Re: Validation of a change to a medical device

what was the reason for this change? e.g. to prevent use errors, to decrease risk, lower cost, etc? did you meet that goal?

did you check whether this change will meet the needs of your users?

The validation is also any testing by a test lab (safety/electrical, mechanical) because the test is performed on a production equivalent unit and simulates actual conditions.
 

JoCam

Trusted Information Resource
Re: Validation of a change to a medical device

Thank you mihzago,

The reason for the change is in response to end-users requesting a non-battery version. We will still be manufacturing the battery powered device, until hopefully the demand falls away due to replacement with the mains powered.

We are aware that we will need to perform safety/electrical, mechanical testing but aren't sure if there are any validation requirements. I believe that providing evidence that (following satisfactory safety testing) it performs exactly as the battery powered device should satisfy the regulatory requirements.
 

yodon

Leader
Super Moderator
Re: Validation of a change to a medical device

You said you fully validated the battery-powered version - so what did you do for that? Do an analysis to determine if the change impacts those results. (Document your work, of course). Then you should only need to do what's impacted and you have documented rationale for not doing the other. (Of course, you may find, in updating your risk analysis, etc. that additional efforts are required anyway but you may be able to limit what gets re-done).
 
B

Burgmeister

Re: Validation of a change to a medical device

One further point to consider - your Notified Body will need to review the changes and, if they are anything like ours, there will be a looooong waiting list to get the changes reviewed. Contact them as soon as possible to arrange a date for the review otherwise you will complete the project and then have to wait 8 months or so for them to look at it and issue a CE mark.
 
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