Class I Medical Device with measuring function: Involvement of NB etc

hello covers...

working on a med dev class i with measuring function certification

the mdd states:
the intervention by the notified body is limited to:
in the case of devices with a measuring function, only the aspects of
manufacture concerned with the conformity of the products with the
metrological requirements

lrqa has a nice document stating:
The aspects relating to the metrology of Class I Measuring Devices that LRQA would assess include, but are not limited to:
• those elements of the risk analysis and essential requirements checklist relating to measuring,
• manufacturers records and procedures relating to measuring aspects and calibration,
• the traceability of calibration,
• units of measure,
• post market surveillance and vigilance systems,
• draft labels, packing and instructions for use bearing the CE marking,
• procedure to prepare and review the Declaration of Conformity,
• procedure to identify what is a significant change and what should be advised to the notified body.

My questions:

What experience do you have with the 'limited' scope of the assesment?
Note the 'not limited to..' clause

Anyone got non conformities on issues not related to measurement functions?

Does the NB look at the whole technical file in detail or just diagonal and picking out the metrological items?

Do they actually look at say 60601-1 or 60601-1-2 (EMC) or 10993-1 reports, the 2 latter being not relative to a measuring function?

I guess this also applies to the QMS as required by annex V but no certificate to 13485 would be possible with the limited scope, right?
iow to get a 13485 certificate you need to implement an entire qms (providing no exclusions in the scope)?

On a slightly different topic, assume you have the technical capabilities to perform 60601-1 testing (leak current, test finger etc) or even equipment to do EMC measurements (i have a test chamber at my disposal but not accredited for medical stuff), can you generate your own report and use that?
Or does the NB only accept these compliance reports from accredited labs?
I can't find in the 60601-1-2 that you cannot do your own emc measurement...


thanks
Jay

Hi Jay

This is a good list from LRQA and covers the main aspects that the NB should look at.

However as soon as you have controlled procedures, you probably require a Document Control system which might be audited, training may also be included. If laboratory space is needed for measurement testing, then Environmental Controls and resources may come up.

In my experience, the NB will check to ensure that all nescessary parts of the Technical File are present (see the MHRA guidance for Class 1 devices), but not audit the file.

I dont think you need to get the 60601 testing performed by an accredited lab, but if you do it in-house, then the calibartion, training, etc would get looked at more carefully.

Hope this helps,

Chris

Thanks Chris,

This confirms my expectations.
Not to duck any responsibility just to estimate the dept of such audits, we will of course have a full blown qms and well documented technical file. A doc control system was the first thing is setup when i joined the company.

The MHRA has a few interesting documents, i did not have the one on class i devices from them, thanks for pointing me in their direction.

Jay

Good discussion. Pretty much any part of the quality system can touch upon the safety and effectiveness of a device with a measuring function, so while Notified Bodies will stick within sensible parameters, there does need to be flexibility all round.

Hi,
Can you pls. provide the link to the LRQA checklist?
In the case of devices with a measuring function, how in practical terms can one limit the NB's involvement only into the aspects of manufacture concerned with the conformity of the products with the metrological requirements.
Does it mean on site reviews or just the technical file review? Does the self declaration have to be co-signed by the NB?
Thanks to anyone who camn enlighten me

Anyone would care to answer this old post? thank you!

Hi Alex

I dont think there was an LRQA checklist - just the bullet-list in the original post.

MHRA have updated their guidance for class 1 devices:
https://www.gov.uk/government/collections/guidance-on-class-1-medical-devices

It can be difficult to limit NBs just to metrological requirements, If they are going off-scope, then a gentle reminder may be in order. However checking metrology can include physical site tours and demonstrations, as well as reviews of V&V documents and Technical Files.

Chris

Thank you!

I just find hard to know exactly what is the "technical documentation" required for a class Im MD. At this point I have: technical file (sted), sop's for development, validation of measuring function, validation report and DoC (per annex V). I just don't know what other documents may be missing (the NB is not helping much).

Alex

Hi, I used to have the same problem, but if you look a the MHRA link, it lists what needs to be included in the "Technical Documentation".

• Description
• Raw material and component documentation
• Intermediate product and sub-assembly documentation
• Final product documentation
• Packaging and labeling documentation
• Design verification
• Risk analysis
• Compliance with essential requirements
• Clinical evaluation in accordance with Annex X

I would suggest writing a short SOP describing what how to CE Mark a class 1 device and reference the MHRA guidance. There isn't much an NB (at least an UK NB!) can argue with then.

Chris

Thank you again very much for the help!
I have all that info in the technical file (with the necessary adaptations because it is a software) and other documents are annexed to detail the info written in the technical file... I believe I have all of what is needed but it's a bit tricky to adapt this to a software md.