Identification of Medical Devices in MDD 93/42 Certificate

R

rcjpedro

Hello All!

Thank you for the time you will take to read this. We are manufacturers of already CE marked Medical Devices.

These Medical Devices are identified in our certificate by its "family" name. Each "family" is composed of, lets say 3 main components, each component can have 20 variations - volume, electrical power, etc.. - simple calculations reach 8000 combinations per "family".

We have been warned that we might have to list all of the elements of each "family" in our certificate.

Can any of my fellow members advise on how to reason regarding this subject?

Already checked our competitors and they also have their medical devices identified by "families" in their certificate.

Any insights is much appreciated.

:thanks:
 
C

ComplianceEngineerig

Re: Identification of Devices in 93/42 Certificate

Hello RCJPedro,

If I understand you correctly, your auditor will have you to identify all components / elements in your certificate?

But this is unnecessary as your "device" has been CE marked with the components in it, so if you are going to make changes, of course, this must also be approved by your auditor again unless those changes have been approved by your auditor.

Hope it helped a little

Regards
 
Ronen E

Ronen E

Problem Solver
Moderator
Re: Identification of Devices in 93/42 Certificate

rcjpedro said:
Hello All!

Thank you for the time you will take to read this. We are manufacturers of already CE marked Medical Devices.

These Medical Devices are identified in our certificate by its "family" name. Each "family" is composed of, lets say 3 main components, each component can have 20 variations - volume, electrical power, etc.. - simple calculations reach 8000 combinations per "family".

We have been warned that we might have to list all of the elements of each "family" in our certificate.

Can any of my fellow members advise on how to reason regarding this subject?

Already checked our competitors and they also have their medical devices identified by "families" in their certificate.

Any insights is much appreciated.

:thanks:
Click to expand...

Hi,

It's very common to list devices by families when there are large numbers of variants that differ quite little from each other (same intended use, same basic design, same principles of operation etc.).

Your description of the situation calls for these questions:
1. By who were you "warned"?
2. According to the "warning", who might pose the requirement?
3. Under what exact regulatory clause might you be required to list all variants?

Ronen.
 
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