Raw Materials Suppliers to EU medical device mfrs.


Starting to get Involved
Hello all,

I am new to this industry, and some of our customers operate in this space. As a supplier of bulk, raw materials-- what should I be aware of, what requirements will filter down to my company? REGULATION (EU) 2017/745

Thank you``


Super Moderator
Question ahead: are you going to restrict your raw materials in type of body contact, e.g. whether they can be used in invasive devices, or exposure duration, e.g. whether they can be used in permanent implants, or for usage in medical devices of certain (high) risk classes?


Starting to get Involved
That is an excellent question. What is the impact, whether we do, or if we do not restrict the type of contact/application?


Quite Involved in Discussions
It's not necessarily your responsibility to restrict the use - your customers will need to evaluate whether your product meets their needs. Materials must be evaluated for their specific application so even if you do some basic testing, it may not be sufficient or applicable to what your customers are doing. The material itself may be acceptable but depending on your processing/sourcing/certification, they may not be able to use you as a supplier for higher risk applications. However, if you know your product is not suitable for certain uses (eg, if you know that it is not stable after being irradiated or steam sterilized), you should provide that info.

You will need to be prepared to provide your customers with a lot of information (source materials, traceability, sub-suppliers, etc). For some applications they will expect full traceability to your sources. Depending on the criticality of the material, you may end up being a crucial supplier and need to be audited. Strong purchasing controls and the ability to demonstrate that the product is consistently meeting spec is key.

Speaking from the other side, I have run into lots of struggles with suppliers who say they support "medical device" use but are uncooperative and won't give us the documentation needed to actually be compliant. Of course that's their prerogative as a business, but it wastes everyone's time. State upfront what you can and can't do, and let us manufacturers figure out whether it will work for us.


Starting to get Involved
OK, thank you for your response. The reason for my 2nd question was to understand the varying levels of requirements, based on the application. I anticipated the traceability aspect and we are in good position there. It's my understanding my company has been quite candid about our compliance to ISO-13845 and other standards-- we check some boxes, not all. However, it is helpful to understand our customer's context so we can meet as many expectations and needs as we can-- with practicality and feasibility in mind, given the markets we serve.

Considering it--doing a gap analysis may be the next logical step. Once we catalog them, our team can make decisions on which items we choose to make an effort to meet, or continue in the status quo.
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