Partial Compliance to an ISO Standard for Medical Device CE Marking

M

Mike Blanc

Dear All,

My company is making a new device and we had used an ISO standard as product standard. This device has certain new and improve features, as a result we are unable to meet only one of the ISO standard requirement.

My QA colleague mentioned in order to get CE mark for this device (class IIa), we will need to comply 100% to the ISO standard.

My questions are:
1. Do I need to comply 100% to the standard in order to claim compliance?

2. If I do not claim compliance to the standard, will I still able to get the CE mark?

3. Can I claim partial compliance to the standard? E.g Comply to ISO XYZ, exclude clause 1.2.3.

4. By claiming partial compliance, will it affect the application for CE mark (device is class IIa)?

Looking forward to your advise.:thanx:
 
M

Mike Blanc

Re: Partial compliance to an ISO standard for CE marking

Hi Joanne,

No, it is a non-active medical device ISO standard.

Will you be able to provide any guidance document or regulation? My QA colleague is a tough nut to crack.
 
J0anne

J0anne

Joanne
Re: Partial compliance to an ISO standard for CE marking

Mike - you can apply any standard you choose in part.
You can claim compliance to a standard with justifications for any exclusions.
This will not affect your CE Marking.
 
somashekar

somashekar

Leader
Admin
Re: Partial compliance to an ISO standard for CE marking

How you meet the essential requirement is of importance...
Justify same (harmonized standards first + other standards if not within the harmonized)
Provide evidence
.
..
...
Discuss threadbare with your NB
 
O

Oz32

Registered
I have an odd question that came up - if part of a standard isn't applicable, do you have to claim partial compliance?
 
Y

yodon

Leader
Super Moderator
Maybe it depends on the circumstances but, for example, we do products frequently that must comply with 60601-1 but don't have, say, pressure vessels. When preparing for the testing, we just claim those as N/A. The test report shows what was tested / what was N/A.
 
O

Oz32

Registered
yodon said:
Maybe it depends on the circumstances but, for example, we do products frequently that must comply with 60601-1 but don't have, say, pressure vessels. When preparing for the testing, we just claim those as N/A. The test report shows what was tested / what was N/A.
Click to expand...

Thank you. And on an ERC for example, do you list full compliance since you fully comply to anything applicable?
 
R

robert.beck

Involved In Discussions
only list what you comply with. if compliance is limited there should be a justification, in the test report, or in the technical file. the justification would most likely be risk-based if in the technical file, or N/A if in the test report. some test houses use N/E for "not examined' and issue a test report that mentions the parts of the standard that were not examined. These types of incomplete test reports are sometimes mistakenly used as indicating compliance by naive users. in my experience with big-name test houses that use N/E, it's often because they did not understand the device.

I agree with Yodon about 60601-1. that is a long extensive standard that covers a lot of ground; much of it does not apply to many devices. for those situations, it's perfectly legitimate to indicate that the essential requirements of 60601-1 are met.
 
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