ISO 13485 Definitions - Medical Device Component Supplier

[sbio1]

Need help. A chemical supplier for a medical diagnostics company (Class I medical devices) received ISO 13485 certification with the scope of development, manufacture and marketing a certain product group for diagnostics, i.e., critical biotech. reagent, e.g., enzyme. Is the reagent, e.g. enzyme, a "medical device" or just a "product" by definition within the framework of the ISO 13485 quality management system??? within the framework of FDA QSR? within the framework of EU IVDD?

 

[Sidney Vianna]

Based on the ISO 13485:2016 definition of medical device, it seems to me the product you described qualifies as one.

medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means

 

[sbio1]

GHTF/SG1/N29:2005 (forward ref. from ISO 13485 clause 3.11)

5.2 In Vitro Diagnostic (IVD) Medical Device
‘In Vitro Diagnostic (IVD) medical device’ means a medical device, whether used
alone or in combination, intended by the manufacturer for the in-vitro examination of
specimens derived from the human body solely or principally to provide information for
diagnostic, monitoring or compatibility purposes.
Note 1: IVD medical devices include reagents, calibrators, control materials, specimen
receptacles, software, and related instruments or apparatus or other articles and are
used, for example, for the following test purposes: diagnosis, aid to diagnosis,
screening, monitoring, predisposition, prognosis, prediction, determination of
physiological status.
Note2: In some jurisdictions, certain IVD medical devices may be covered by other
regulations.

Still in doubt... Let's say the finally assembled IVD test system is just one tube with a solution (i.e., clearly a "medical device" and "reagent). This solution is a simple mixture of three different solutions supplied by chem. company that is only ISO 13485 certified. Are those 2-tier reagents also "medical devices"?:
1. no intent to provide any diagnostic information? just an intent to supply "a part" for final assembly.
2. legal liability concerns, e.g., a supplier is in EU and does not have EC mark, just ISO 13485, and therefore cannot name the products a "medical devices"?

 

[Sarah Stec]

Welcome!

2. legal liability concerns, e.g., a supplier is in EU and does not have EC mark, just ISO 13485, and therefore cannot name the products a "medical devices"?

Whether a product is a medical device or not depends on whether the product meets the regulatory definition, not on the status of the manufacturer/supplier of the product. So, the manufacturer/supplier may have no certifications at all and still have a medical device. Likewise, just because you have a medical device may not mean that you are a manufacturer within the regulatory definition.

Is your company putting this on the market? Or are you shipping it to someone else for them to put on the market?

Let's say the finally assembled IVD test system is just one tube with a solution (i.e., clearly a "medical device" and "reagent).

The whole test system can be the IVD medical device if they are intended to be sold together. An IVD is a tube (the vitro in in vitro diagnostic) and a solution.

1. no intent to provide any diagnostic information? just an intent to supply "a part" for final assembly.

The question then becomes who is doing the intending: the chemical company doing the supplying or the manufacturer putting the IVD (tube + reagent) on the market? Is the chemical company "just intending to supply a part for final assembly"...for the purpose of diagnosis (or another IVD purpose)? Or is the chemical company selling a general purpose chemical that the manufacturer happens to use for a diagnostic purpose?

Tl;dr: You don't have to be a "manufacturer of IVD medical devices" to have an IVD medical device.

And you may want to stick to the legal documents (so, not the GHTF, but the FDA regs and the IVDD) when you're figuring out your legal liability.

 

[sbio1]

The question then becomes who is doing the intending: the chemical company doing the supplying or the manufacturer putting the IVD (tube + reagent) on the market? Is the chemical company "just intending to supply a part for final assembly"...for the purpose of diagnosis (or another IVD purpose)? Or is the chemical company selling a general purpose chemical that the manufacturer happens to use for a diagnostic purpose?

The chemical company: - is not putting the IVD (tube + reagent) on the market
- is manufacturing and supplying 3x different bulk chemicals to the customer in US
- the QMS is ISO 13485 certified; the chemicals are mentioned in the issued certificate
- is accepted supplier; passed on-site audits conducted by the customer
- declares intent that these bulk chemicals can be used for manufacturing the IVD
- does not formally label the bulk chemicals "for in vitro diagnostics" or with "EC Mark"

The customer: - is manufacturing the IVD + reagent from the 3x different bulk chemicals received from The chemical company
- meets all applicable FDA and IVDD regs
- is putting the IVD (tube + reagent; Class I device acc. to FDA regs classification) on the market in US and EU

All the questions concern The chemical company and the 3x bulk chemicals:
1. From perspective of FDA each of the 3x bulk reagents is medical device? Yes/No?
2. Within framework of the ISO 13485 (e.g, from ISO 13485 auditor perspective) each of the 3x bulk chemicals is medical device? Yes/No?
3. From perspective of EU regs each of the 3x bulk chemicals is medical device? Yes/No?
4. Is the company allowed to use in marketing materials the term "medical device" when referring to those bulk chemicals?

1. No; 2. Yes; 3. No; 4. Yes
???