Bill of Materials required according to MDD93/42/EC Annex II Section 3.2

[Jeffers]

Hello Elsmar,

As always, thank you in advance for the assistance and time spent. Back at it again - this time I have another NC identified by my reviewer in the process of reviewing my technical documentation. Specifically, the reviewer identified the following NC:
Client has not submitted a Bill of material.
The requirement is listed as MDD93/42/EC Annex II section 3.2.

It has always been my understanding that a BOM is most applicable to devices that utilize computer or electronic circuitry, but not necessarily a medical device like the device we manufacture. The device I manufacture is akin to dental floss. We perform a chemical process on a raw material. Following the chemical treatment, the product is ready for use and prepared for sale. We are not necessarily combining multiple items into a single finished product.
I have gone through the MDD, and do not see any requirement to provide a BOM. Am I missing something significant? Thank you experts!

 

[Marcelo]

Re: Bill of Materials, required according to MDD93/42/EC Annex II Section 3.2???

A BOM is not required by the MDD. The MDD does not require any "type"of document, in fact.

On the other hand, a BOM is a type of document that can be created for any device (for simples devices it would be very brief).

 

[Mark Meer]

Re: Bill of Materials, required according to MDD93/42/EC Annex II Section 3.2???

Very odd citing. I'd challenge it, as the cited reference (MDD93/42/EC Annex II section 3.2) clearly says nothing about a required bill of materials...

That being said, I'm surprised you don't maintain one. At the very least, do you not have suppliers for the packaging & labelling, in addition to the floss materials themselves?

 

[Jeffers]

Re: Bill of Materials, required according to MDD93/42/EC Annex II Section 3.2???

To elaborate, there is another reference to the original finding, "It is not clear why Bill of material is not applicable."

Mark: I have a section within the Technical File that was submitted entitled, "Approved Vendor List". The section consists of a table that lists my suppliers and the items obtained from each source. This table was included in the report for a different section, but the NC remained.

My understanding of BOM:
I have limited experience with electronic medical devices, but my understanding of a BOM is slightly different than the vendor list. A BOM is generally provided for a specific product, and in the electronics world, it would provide an entire list of the individual "components" that make a device. For instance, a BOM for a lighting device could be quite simple, but would include battery clips, on/off button (if standard issue), LED, LED housing, etc. It would often include standard part numbers, which would enable ordering from various suppliers. It then would be a matter of utilizing suppliers with the appropriate certifications (price varies!) This BOM would NOT include the box for the flashlight, just the individual components of the device.

In the example that Mark mentioned, the BOM would consist of the raw materials floss, the wax material that is the coating, and possibly any flavoring agents.

I think the most important part of the answers that everyone provided is, "it is not in the standard". Unfortunately, I only have one more round of revisions on the Technical File, so there is not too much "wiggle room" for me! Thank you in advance!

 

[yodon]

Re: Bill of Materials, required according to MDD93/42/EC Annex II Section 3.2???

Agree with all the responses so far. And I think Mark Meer's response was heading in the right direction. The general purpose for a BOM is to specify to the greatest extent needed, the materials / components going into your device (and, frankly, most of my clients have a 'system' level BOM that DOES include the 'box for the flashlight' as you say since in many cases, that's part of the packaging / shipping validation!). For very common components like screws that don't have direct bearing on safety or efficacy, specificity is not all that great. For adhesives that are patient-contacting, though, we specify supplier and manufacturer's ID for the adhesive. And, of course, this also flows right into traceability.

So how do you specify down to the appropriate level? Agreed it's not required to be a BOM but I expect the finding is probably trying to ensure the product can be manufactured the same way (materials- and property-wise) each time.

 

[Ronen E]

Re: Bill of Materials, required according to MDD93/42/EC Annex II Section 3.2???

A typical BOM details all the components/ingredients of the finished device, including quantities per unit (very important).

The MDD might not explicitly require a BOM as such, but it does require in Annex II s. 3.2 some information that would be readily available from a BOM. If that information is available in other ways, you comply. I assume that your reviewer was "complaining" because some of that information was either not available in your tech documentation, or just hard to find.

The following requirements from s. 3.2 (c) seem relevant (I highlighted the relevant items):

— the design specifications, including the standards which will be applied and the results of the risk analysis, and also a description of the solutions adopted to fulfil the essential requirements which apply to the products if the standards referred to in Article 5 are not applied in full,

(...)

— a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

— a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC (1),

Please note:
1. Design specifications include what the device is made of and in what quantities.
2. A BOM could indicate whether or not medicinal substances, human blood derivatives and/or tissues of animal origin have been utilised/incorporated in the device (I understand it's not your case, but you're still required to address it).

Again, the above don't mandate you to include a BOM but you do need to make sure that those requirements are met in some way.

Cheers,
Ronen.