Great discussion!
I personally have a really strong opinion here:
The scope section of ISO 10993-1 clearly defines that the standard applies only to devices with
- patient contact during intended use
- user's body only if the device is intended for protection.
So I would always try to argue that any other user contact is out of scope unless there is a specific risk.
Section 5.2.2 contains a note about short term user contact to human interfaces for electronic equipment (keyboards, dials, buttons etc.): "If these types of components can be shown to be made from materials in common use for other consumer products with a similar nature of contact, no further biological evaluation is needed."
A possible approach could be to briefly evaluate those components (e.g. in the risk managment) with the aim to define them as out of scope of ISO 10993-1.
But it will get really difficult once you try to evalute such components in detail, because:
a.) You usually still have some customized components and surfaces (e.g. specific coatings, surface finishes or colors),
b.) Many suppliers do not want to provide details about the chemistry or composition of surface materials (or just don't have the data available), and
c.) The most clinically relevant endpoints for skin contact are sensitization and irritation. Those are difficult to evaluate if you do not have full information about the chemical composition.
A client once told me that during a notify body audit the auditor also insistent on an evaluation of EACH user contacting component of a complex system.
I was lucky so far with a clear distinction between user and patient contact....
------------------------------
Michael Hottner
Köln
Germany
------------------------------
Original Message:
Sent: 16-Nov-2022 15:33
From: Christine Stahley RAC
Subject: OEM Product Biocompatibility
I had a suspicion it was what the reviewer wanted but I was in disbelief. We had to get on a call with the reviewer to confirm the request because we honestly didn't think the assessment had to be every single part, including the power cord, that the user touches. Submissions are not getting any easier, that is for sure!
------------------------------
Christine Stahley RAC
Regulatory Affairs
Grafton MA
United States
Original Message:
Sent: 16-Nov-2022 15:01
From: Richard Vincins
Subject: OEM Product Biocompatibility
Christine,
'... and the reviewer insisted the entire medical device system be assessed for biocompatibility, including parts that are only touched by the user, i.e. footswitch.' That just makes me sad and annoyed. It is a truly sad world we live in today where pragmatism and common sense are lost to checklists and unrealistic expectations.
While I agree certain components or products could be reviewed ... but a footswitch or a touch panel/buttons? Next they will be asking for biocompatibility on the iPhones which have Apps on them, because you know Apps can be medical devices !!
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 16-Nov-2022 14:03
From: Christine Stahley RAC
Subject: OEM Product Biocompatibility
Hi Taisiya,
I recently worked on an EU MDR submission for a class IIa and the reviewer insisted the entire medical device system be assessed for biocompatibility, including parts that are only touched by the user, i.e. footswitch. While we did not have to perform biocompatibility for those components, we did however have to show that we assessed each component and provide a justification as to why it was not required.
So I agree with your inclination that you should have some justification documented as to why parts of the device that come into contact with the user do not require biocomp and are also compliant with regulations specific to CMR and Phthalates.
------------------------------
Christine Stahley RAC
Regulatory Affairs
Grafton MA
United States
Original Message:
Sent: 15-Nov-2022 18:02
From: Taisiya Novopachennaia
Subject: OEM Product Biocompatibility
Hello,
I am working on an EU MDR tech doc submission of a Class IIb CT Scanner. This device is sold with and recommended to be used with an OEM Class I device. The OEM device has buttons that are intended to be pressed by the user but is not intended to come into contact with the patient. The OEM device is CE marked under MDR, however the DoC does not list ISO 10993-1 under product conforming standards. The manufacturer will not provide any reporting or justification for not performing ISO 10993 testing outside of an email stating it is not necessary because of lack of direct or indirect patient contact.
Section 6.1(b) of Annex II in EU MDR states a need for "biocompatibility testing of the device including identification of all materials in direct or indirect contact with the patient or user." My thinking is that biocompatibility testing or a justification report (i.e. materials are common and therefore risk is low) is necessary since MDR specifies the user, not only the patient.
Given that the CT Scanner is sold with the OEM device, is it enough to rely on the MDR CE Mark of the OEM device or do we need to do more due diligence in ensuring that the OEM device is biocompatible?
Thank you in advance!
------------------------------
Taisiya Novopachennaia
San Diego CA
United States
------------------------------