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Medical Device File

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Guest user Created:   Oct 12, 2020 Last commented:   Oct 22, 2020

Medical Device File

I do have queries pertaining to implementation of ISO13485:2016.  

In particular on top of my list is about the Medical Device File or MDF.  Read through some articles, forums, blogs but I think I better seek advice from experts like you on this topic. 

Although the ISO standard explicitly stated major areas for compliance as per clause 4.2.3, sub-clauses (a) through (f). I am keen to know what exactly are the documented information that fall into these categories. 

I greatly appreciate receiving feedback from you on this subject.  Looking forward to receiving your reply. 

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Kristina Zvonar Brkić Oct 12, 2020

Medical device file is a Technical file for medical devices. That means that all requirements from the Medical device directive 93/42/EEC (MDD) or Medical device regulation 2017/745 (MDR) must be there. 

However, a number of documents stated in section 4.2.3 Medical device file in ISO 13485:2016 are much less than those stated in the Directive or Regulation, so that can be confusing. But, in this section 4.2.3 is also stated that the organization must establish files to demonstrate both compliances with the standard and applicable regulatory requirements. Technical requirements from either MDD or MDR is applicable for all medical devices, regardless of the type of the medical device. 

Here you can find the List of all technical documentation according to the MDR is stated in Annex 2 – Technical documentation: https://advisera.com/13485academy/mdr/technical-documentation/

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Guest user Oct 13, 2020

Hi Kristina,

Thanks for your prompt response.  

I got a better understanding now of the MDF especially your pointing out that - clause 4.2.3 of ISO13485 has lesser documentation requirements than the MDD or MDR but the same standard calls out for compliance to both standard and regulatory requirements, and the MDD or MDR technical requirements are applicable for all medical devices regardless of the type of medical device.

I do have a follow up question related to this.  Our organization is not producing a medical device but rather manufacturing a component or sub-assembly for a module that is a part of the medical device product.  If the final medical device product is from a level 1 supplier, we might consider ourselves to be a level 3 supplier, i.e., we are supplying a part to the supplier (our immediate customer) who supplies a module to the final medical device manufacturer.

In such a case, not all prescribed MDF documentation are to be applicable to our organization to ascertain compliance with ISO13485 requirement.  Kindly confirm and elaborate.

Thanks and regards.

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Kristina Zvonar Brkić Oct 14, 2020

In that case, you are not obliged to have a medical device file, only necessary documentation about the product and instructions on how your product can be implemented in the final medical device. This means technical drawings, certificates of materials, specification of the product, any specifics necessary for the medical device manufacturer how to integrate your product (installation procedure and or service procedure), labels, and some kind of declaration of conformity which will state under which requirements is your product produced (if there is any).  

 

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Guest user Oct 21, 2020

Hi Kristina,

Thank you for your confirmation that we, as a supplier to the medical device manufacturer, is not required to satisfy ALL of the items identified to compose a MDF.  

About the '...declaration of conformity which will state under which requirements is our product produced...", can we simply specify or make reference to a specification number instead of listing particular requirements or conditions in the said declaration?

We do have a CoC or Certificate of Conformance issued for every lot of shipment made to our customer - I am thinking of just indicating in the CoC the specification number of either the customer or our internal specification which cites the manufacturing requirements of the concerned product.

Kindly advise and confirm.

Thanks and regards. 

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Kristina Zvonar Brkić Oct 22, 2020

It will be good if you can add which standard are applyed durign production (if any), and if you are certified by ISO 13485:2016 it would be great if you could put a number of the certificate, validity date of the current certificate and notify body who issued the certificate.

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