Verification/release medical device modules

Belen Sanchez

Starting to get Involved
#1
I have a doubt about verification/release of a medical device in the place of operation.
Our medical device is a class IIa and because is so bigger, in our facilities we can only verificate it by moduls, not like a final product (assembled). Only when the device is installed at hospital, we can verificate its perfomance. This final verification is made by a third person (technical service of our distributor).

My question is when the release of the medical device is done by the manufacturer (our company)? now we do it with the device not assembled (before leave our facilities) but I'm not sure if this way will change or not with the new 2017/745 MDR.

Thanks a lot
 
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yodon

Staff member
Super Moderator
#2
I think you may be talking to different activities here.

Design verification is intended to demonstrate your design has implemented the requirements correctly. You certainly wouldn't want to defer this activity to when you're installing the product (nor would that be legal since you wouldn't have been able to get through any pre-market clearance requirements without doing so!). There is no requirement that design verification be done on a fully-assembled device (although 13485 now talks to interfaces with other devices).

Design validation is intended to demonstrate your design meets user needs / intended use and there is a requirement that validation is conducted on "representative" product. Again, though, you couldn't defer this to installation time since validation must be completed prior to release to customer. This could be done at a customer site but it needs to be quite clear that it's not released for use.

There are separate requirements for installation activities - which is what you're talking about and 13485 talks specifically to your situation:

The organization shall document requirements for medical device installation and acceptance criteria for verification of installation, as appropriate.

If the agreed customer requirements allow installation of the medical device to be performed by an external party other than the organization or its supplier, the organization shall provide documented requirements for medical device installation and verification of installation.


Both design verification and design validation need to be conducted "in accordance with planned and documented arrangements" and so in your case, if you're unable to conduct design verification on finished product, you may want to float your plans by your NB and get agreement that the approach will be acceptable.
 

Belen Sanchez

Starting to get Involved
#3
Thanks, for clearing, but I'm still with the doubt :rolleyes:
I'm not talking about design phase, this is already verified and validated.
I'm talking about production phase:
1) we verificate that each modul is according to our specifications,
2) the device is released (in a document),
3) each released modul is packaged and shipped,
4) the device is installed in a hospital by a third person under our specifications (verification of assemblied device),
5) it's ready to use

We keep records of all steps, but I'm not sure if we can still doing that according to ISO 13485 and MDR 2017/745, in other words, I don't know how justify how release of asemblied device is before to final verification of the device (assembled device).
 

kreid

Involved In Discussions
#4
I assume your 3rd party installer carries out some type of installation validation, and maybe there is a customer acceptance test?
The evidence of these final steps should be part of your technical file, and hence, prove that the full assembled device is valid.
 

yodon

Staff member
Super Moderator
#5
Thanks for clarifying. Sounds like what your doing is about all you can do. Ensure your records show the modules were accepted and then, as @kreid notes, make sure your 3rd party installer captures installation records showing the installation was verified.
 

Belen Sanchez

Starting to get Involved
#6
Thanks for your comments. Now our Notified Body has told me that with the new MDR it will be necesary the verification of assemblied device before releasing, do you know where is that requirement in the MDR 2017/745?
 

yodon

Staff member
Super Moderator
#7
Ask them what clause they are citing that's driving this.

I see in Article 15, item 3(a) (the PRRC is responsible for ensuring that):
the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

I would certainly think it would be defensible to ensure that each module meets spec and show that if this is the case and installation instructions are followed, the fully-assembled device will meet spec. You might need to do some validation work on the installation process (assembling the modules, considering failures and risks - a pFMEA might be helpful) and have that available for the NB to support your position.

The situation is pretty fluid right now. The NB may be taking a hard-line stance. Hopefully they can come around to some common-sense thinking. I think your best bet is to have the dialog.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Just change the definition so that Release occurs not when you deliver the modules but after installation, including verification is complete. Maybe consider changing your process so that the installer is required to send you a copy of the signed-off installation / whole-device verification, and only then you issue the user a formal document asserting that the device is released for use. The EU terminology has a useful term - Putting into Service (rather than Making Available on the Market). Maybe you can leverage that concept. Please send me a PM if you're interested in me studying your situation in-depth.
 
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