Do MDD (Medical Device Directives) Devices require MDD components?

P

ptaillie

#1
I am reviewing a DR Imaging system w/ a Notified Body. The DR detector is CE marked, but not to Class IIa. The auditor says this component of the system must be Class IIa certified before the system can be certified as Class IIa. Alternatively, if all of the Essential Requirements are shown to be met by the detector, the Class IIa cert is not required for the detector. The problem is that the detector vendor has not done all of the Class IIa testing. Is this a real requirement? Was it introduced in the 2007/47/EC change? I know I have sold detectors in EU as part of an imaging system w/o Class IIa cert before, under the mindful eyes of a Notified Body. Thanks for any help you can give.
 
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M

MIREGMGR

#2
It's fundamental that if a system-product is to be type-approved based on existing conformance determinations for its subsidiary critical components, those existing conformance determinations must be for at least the class to which the system-product is to be type-approved; or, that the system-product must be determined to be conformant on its own, without reference to existing conformance determinations for subsidiary components.

As far as I know, conformance determination for systems has always been properly handled via one of these paths or the other.

I would expect a type approval authority to exhibit flexibility regarding required classification for non-critical components, but obviously the detector of an imaging system wouldn't be subject to that exception.
 
P

ptaillie

#3
Thank you both for your responses. I agree with your assessment. I am just confused as to how the two companies I worked at in the past did not have to provide all of this proof for non-Class IIa detectors (when included in Class IIa devices). Further, I don't know why big detector companies are not getting Class IIa approval, and how they have sold product in EU without it, or the underlying proof. This is putting a monkey wrench in my present product introduction plans, and I want to be sure I really need this to be done before I put a lot of time into it. Thanks again.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thank you both for your responses. I agree with your assessment. I am just confused as to how the two companies I worked at in the past did not have to provide all of this proof for non-Class IIa detectors (when included in Class IIa devices). Further, I don't know why big detector companies are not getting Class IIa approval, and how they have sold product in EU without it, or the underlying proof. This is putting a monkey wrench in my present product introduction plans, and I want to be sure I really need this to be done before I put a lot of time into it. Thanks again.
Hello and welcome to the cove :bigwave:

It is very important not to confuse between medical devices and components thereof, wherever the latter are not medical devices in their own right.

I am no expert on DR, so I'm referring to the generic principles; you can then apply them to your field.

Speaking in general terms, there is no generic requirement for medical device components to qualify for CE-marking in order for a system (or device) containing them to qualify as well. As far as I know, this is true regardless of class and a given component criticality. There might be (easier) qualification routes that are based on such hierarchy, but typically there would be more than one path to CE-marking and it is up to you to consider and conclude which are accessible to your company / product, and which are preferred.

Of course, there could be specific requirements applicable to DR - as I stated above I'm no expert in this field. If this is actually the case, you can politely ask your NB to point the exact regulation section they refer to, and continue from there.

Having said all that, if the component (in this case, the detector) can be considered a medical device on its own, then yes, it would be required to comply with the MDD in order to be sold in the EC (even if the buyer esentially uses it as a component). The definition of a medical device can be found in the MDD and is quite clear in my opinion; you could try and read it on the detector as-received, and see if it holds. regardless of that, the detector manufacturers must comply with all (other) applicable EC directives before they sell these detectors in the EC, and if any of theses directives is one that leads to CE-marking then the detector should be marked accordingly (not necessarily as a medical device).

Cheers,
Ronen.
 
M

MIREGMGR

#5
I 100% agree with Ronen's comment, and would note that this underlies the alternate path of a full Essential Requirements analysis of the imaging system without reference to any pre-existing MDD conformance establishment for the detector module.
 
A

AMIGOS

#6
This is my first post....so bear with.

I have a customer who wants the components that we use (for a device we are designing) to be medically approved - I am right in presuming medically approved is CE marked or is there another method? Also, what implications would this have on the device? Can I presuade them against this as the device will go through CE marking approval/clinical investigations etc prior to release (the device is Class IIb)

Thanks
AM
 

somashekar

Staff member
Super Moderator
#7
This is my first post....so bear with.

I have a customer who wants the components that we use (for a device we are designing) to be medically approved - I am right in presuming medically approved is CE marked or is there another method? Also, what implications would this have on the device? Can I presuade them against this as the device will go through CE marking approval/clinical investigations etc prior to release (the device is Class IIb)

Thanks
AM
Thanks to Ronen E.
Please make a clear distinction between component and accessory to a medical device. An accessory is a medical device in its own capacity and can be placed in the market as a medical device and this will have to be CE marked per its class. Take the case of a pulseoximeter and its probe. The pulseoximeter would be class IIb while the probe can be designed and assessed to meet class IIa or class IIb.
Component on the other hand by itself cannot be a medical device in its own capacity. I have seen several components where in the data sheet mentions meeting several safety standards and its typical application areas including medical devices, with a note that when used in medical device, the fitness for its use must be assessed by the medical device designers.
 
A

AMIGOS

#8
Thank u!

Yep by component I mean the actual components e.g. resistors/ICs etc that make up the device, not an accessories.

A
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Thank u!

Yep by component I mean the actual components e.g. resistors/ICs etc that make up the device, not an accessories.

A
Hi,

In this case, the closest thing I know to "medically approved" is compliance with applicable parts of IEC 60601 series, though IMHO it makes little sense to apply this standard to resistors and such (as it is intended for electrical medical equipment).

I would strongly urge you to try and explain to your customer that "medically" qualifying the components has little added value on top of the high-level MDD compliance (CE marking) of the final device. If they seek extra confidence in the quality of raw ingredients, then I believe there's a host of more appropriate industry standards to ensure resistors and such are of high quality. Having said all that, it's always important in business to remember that "the client has the right to be the client":cool:, meaning, if the client is not happy with you / the product, they may seek happiness somewhere else :(

Cheers,
Ronen.
 
Last edited:
M

MIREGMGR

#10
There's another possible interpretation of a design/manufacturing customer spec that components must be "medically approved".

Many makers of component materials and devices are gunshy about the use of their products in applications that have an adverse history regarding civil lawsuits in the event of less-than-optimal performance. Such component makers frequently impose terms of sale that attempt to establish an agreement-by-purchase not to use their products in those product types--frequently, in medical devices--and to indemnify the component maker against judgments, damage to reputation, costs of staff time, legal counsel costs, etc.

Such conditions and contractural barriers are very common in regard to two use-types...life safety systems, and implantables.

Thus, "medically approved" might refer to a component maker not establishing such constraints against medical-device use.
 
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