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Medical Device MRI Compatibility

#1
Relatively new to the regulatory game and still finding my feet somewhat. I am currently updating our some of our Instructions for Use as part of ensuring compliance to MDR. Is it right that we need a section “Use of the device during diagnostic, investigation, evaluations or treatment” I thought I had seen this in the MDR but on reviewing I can’t find it. If that information is required, then I presume it would predominantly relate to using the devices during x-ray or MRI. I guess that we would have to measure against ASTM F2052, is that correct? None of the devices contain metal so would we still have to prove against a standard? Thanks all in advance.
 
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indubioush

Quite Involved in Discussions
#2
From MDR:
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE
14.2 Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible: ....(b) risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects

From ISO 14630:
5 Design attributes
The design attributes to meet the intended performance shall take into account at least the following:
n) effects of radiation, electromagnetic and magnetic fields ....
NOTE Particular attention is drawn to the fields used for magnetic resonance imaging (MRI) in respect of patient
safety. The test methods in ASTM F2052, ASTM F2119, ASTM F2182 and ASTM F2213 can be used to evaluate the
safety of an implant in the MR environment.
 
#3
Hi Indubioush,
Thanks for the info. Do we have to test against the standards or is it permissible to say that from the materials used in construction it is not expected to be affected by MRI?
Thanks
Scott
 

indubioush

Quite Involved in Discussions
#4
You will need to have adequate scientific information that supports your MR labeling claim (MR safe, MR conditional). It sounds like you believe your product to be MR safe. To support this claim, you will need to have a documented review of your materials against published literature or other scientific sources. Please do not think that your product is MR safe just because there are no metal components. You need to do a detailed review of every material and configuration. If this review provides adequate information to support the MR safe claim, you may be able to justify not doing the tests.

Please purchase and read ASTM F2503 thoroughly. Also research other MR labeling regulations or guidelines applicable to you.

Note that your design history file needs to show traceability between MR related design inputs, related risk assessment/evaluation, product requirements, and your scientific review document.
 
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