Customized Medical Device Accessories for Research Purposes Only

M

MIREGMGR

#11
Of course I don't know the particulars of anyone's specific situation, other than my understanding of the brief discussions posted here. All that I can do is help to point out the published rules and other information that seems applicable.

The following text from the 2011 US FDA draft IVD Research Use Only FAQ actually applies to all devices, and describes the basis for the Investigational Device Exemption:

Section 520(g) of the Federal Food, Drug, and Cosmetic Act ("the Act"), 21 U.S.C. 360j(g), provides for the exemption of devices intended for investigational use from certain requirements of the Act if such devices comply with the procedures and conditions prescribed by that section and by regulation. For example, devices intended for investigational use that meet applicable requirements may be exempted from premarket notification and premarket approval requirements of sections 510 and 515 of the Act (21 U.S.C. 360, 360e, 21 U.S.C. 360j(g)(2)(A)); see also 21 CFR 812.1(a). A product?s intended use refers to the ?objective intent? of those responsible for labeling the product. Intent is determined by such persons? expressions or may be shown by the circumstances surrounding the distribution of the article.

FDA's investigational device exemption (IDE) regulation is found at 21 CFR part 812. Under 21 CFR 812.5, investigational devices must bear a label that states the following: "CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use." The labeling may not represent that the device is safe or effective for the purposes for which it is being investigated. 21 CFR 812.5(b). The IDE regulation also prohibits certain practices by sponsors and investigators pertaining to the marketing and distribution of investigational devices. See 21 CFR 812.7.
You said:

since it's class II, an IDE is not needed for the restricted small-scale use that the device is being used for.
The regulatory boundaries are defined in 21CFR 812.2 "Applicability". I'd suggest that you memo-to-file the specific exemption justification that you have determined applies from 21CFR 812.

For instance, maybe your devices qualify as "custom".

21CFR 812.3 defines "Custom device" to be a device that:

(1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
(2) Is not generally available to, or generally used by, other physicians or dentists;
(3) Is not generally available in finished form for purchase or for dispensing upon prescription;
(4) Is not offered for commercial distribution through labeling or advertising; and
(5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
 
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R

Ron Boumans

#12
This is an interesting discussion and I have seen several companies struggle with this problem. Let try to shed some light on this matter.

Basicly the initial question is if there should be a CE-mark on a product that is customised and will be used for research purposes. The answer is not that complicated. It all depends on the intentions of the manufacturer. Let?s go through these intentions step by step.
Step 1: is this a product that falls within the scope of the MDD?
If the product falls within the definition of the MDD, the MDD should be applied. If not, there may be other directives. Let?s suppose we are talking about a medical device or IVD.
Step 2: Is the device put on the market?
If the product is sold or given for free with the intention of the device being used according to its intended purpose, it is put on the market. See the definition in the MDD for a more detailed description.
Step 3: Should there be a CE-mark on the device?
Medical devices put on the market need the CE-mark, ofcourse after the correct conformity assessment procedure. There are two exceptions:
1. A device that is part of a clinical investigation meant to establish conformity does not have the CE-mark, but then the safety should be covered by the right procedure regarding clinical investigations. For IVD?s that are being tested the situation is about the same.
2. Custom made devices don?t have a CE-mark. The reason for this is that these devices are not intended for free movement on the EU market. They are made for a specific user after measurement of that user have been taken by a professional. Mass produced products that are adapted for specific situations are not considered custom made devices.

So as usual, it turns down to the intentions of the manufacturer!
 
J

JSambrook

#13
I appreciate this thread and the responses above.

Let's say that a company is producing a complex electronic device, and they have worked to design and build it in a RoHS compliant manner, and they have subjected it to EMC testing, etc. The device is not a medical device and is not marketed as such, but it is marketed for the express purpose of facilitating research in domains where medical devices are often built.

The device is not sold with the CE Marking. But my understanding is that if a device is subject to any of the Directives associated with CE Marking, then it must carry the Marking, or it cannot legally be placed on the market.

I further believe the device is almost certainly subject to the Low-Voltage Directive, and also, the WEEE Directive.

However, the company is claiming that because their device is intended for research use, that it is exempt from the CE Marking requirements.

I think this is incorrect. I'd welcome any clarifying comments on this.
 
R

Ron Boumans

#14
The exemption for clinical investigations for medical devices or 'research only' for IVD's is only made because this allows evaluation of the performance of non-CE marked devices, as part of the conformity assessment procedure. This exemption is not applicable if the investigation is done with the intention of gathering data from humans without the intention of diagnosis or treatment for the individual that is being investigated. Even if a product is used to gather data from a cohort of patients suffering from the same condition, with the intention to develop a new intervention, this is not considered a medical device if this information is not used for diagnosis or treatment of the individual.

RoHS, EMC and other applicable directives will require CE-marking to demonstrate the product is compliant will all of the applicable Directives.
 
#15
As Ron says RoHS2, LVDD, and EMC directives are all CE marking directives.

As such the CE mark is required as well as a Declaration of Conformity (see each directive for the required contents of each DoC).
 
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