Essential Requirements Checklist w/o ISO 13485

J

jennaleeb

Hi everyone! Thanks to everyone who contributes to this forum, it is so valuable.

My question is in regards to meeting the essential requirements. We are a small start-up that makes a Class I non-sterile medical device. We are working towards ISO 13485 but in the mean time are also hoping to place the product on the market. In order to meet the ERs, as I understand it, the easiest way is just to refer to your ISO certification.

BUT! If we aren't ISO certified by the time we are ready to self-register, how does one demonstrate compliance? Refer to our risk reports/clinical evaluation/etc?

Does anyone have experience doing this without ISO 13485 certification?

Thanks!

Jenna
 
C

Chris Ford

Hi Jenna,

I'm actually doing exactly the same thing right now for Class I, non-sterile devices with no measuring function. CE marking Class I devices is very similar to FDA's registration and listing requirements for Class I devices in the US.

First just to clarify, conformity assessment is the method you use to demonstrate that the device complies with the essential requirements. ISO certification doesn't demonstrate conformity with the essential requirements. The classification of the device is critical to determining the appropriate conformity assessment route that you'll follow in order to affix the CE mark.

If it's non-sterile and doesn't have a measuring function, you'll use Annex VII, in addition to Annex I and Annex X, which apply to all medical devices regardless of classification.

Technical documentation for Class I devices is not reviewed by a notified body, and conformity to ISO 13485 is voluntary.

You'll still need to compile the technical file, establish post-market monitoring and accident reporting systems for vigilance reporting, issue a declaration of conformity, and apply the CE mark once you've met the relevant essential requirements.

Then you'll appoint an Authorized European Representative to register with the Competent Authority. The representative will register the manufacturing address and descriptions of the devices.

I hope that helps!
 
R

robo407

Jenna, I have recently had a technical file audited with the finding of many deficiencies. According to my auditor, it is not enough to just list your ISO13485 certificate to show compliance to the requirements. Instead you must list the documents in your quality records or from your quality system that are evidence of your compliance. For example, the first requirement, which deals with risk management, would be answered by listing your risk management procedure, by number, as well as the risk analysis, by report number, as well as any studies or tests that were performed.
 
J

jennaleeb

Ok! So instead of worrying about referring to ISO 13485 certification, I should ensure that our procedures/reports show that each essential requirement has been met...

Thanks everyone!
 

somashekar

Leader
Admin
Each and every essential requirement that is mentioned must be first addressed to see if it applies to your kind of medical device. Then you must see how each of the applicable essential requirement are translated into your design input and the related outputs are meeting the input requirements and hence the essential requirements. The help here comes from your product specific harmonized standard and other associated standards of the EU, or from an other international standard(s) if there is no such standard within the EU MDD harmonized standards.
 
K

Kh_Nadja

Hi All!

May I use this thread to ask a question, which has a relation to the discussion here:

In which status (harmonized vs. state-of-the-art standard) is ISO 13485 used as one of the means of conformity to MDD's Essential Requirements?

Looks like it is regarded as a harmonized standard when mentioned as a means of conformity in ER Checklist.
However, if we look into its Annex ZB, it says that it provides presumption of conformity to the Directive's Annexes II, V and VI. It says nothing about coverage of the Annex I "Essential Requirements"! So, does that mean it is not harmonized with ERs?

Then, since no particular ERs are covered according to the standard's annex ZB, how do I know to which ERs it is applicable? Is it those ERs where "design" and "manufacture" mentioned in any way?
And if I mention ISO 13485 as a means of conformity, shall I motivate the choice: "used as a state-of-the-art standard"?
 
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Avraham Harris

Involved In Discussions
KH Nadja,
you are correct and perceptive.
as of 31/08/2012 the standard ceases to give a presumption of conformity with the ER.
Therefore, each ER needs to be assessed to determine which aspect of 13485, if any, fulfills it.
e.g., design and manufacture, as you pointed out.
Remember, ISO 13485 fulfill the function of showing a presumption of conformity with the mentioned annexes, so it is both necessary and helpful.
 
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