European Medical Devices Classification ?MEDDEV 2. 4/1 Rev. 9 June 2010?

bio_subbu

Super Moderator
#1
European Medical Devices Classification “MEDDEV 2. 4/1 Rev. 9 June 2010”

Dear All

Hope you all aware of the latest changes on the European Medical devices classification “MEDDEV 2. 4/1 Rev. 9 June 2010”. In connection to that I have prepared a excel sheet, which you can find details of product classification in category wise (Non invasive devices, Invasive devices, Active devices, Special rules) for each product. This document will be useful to medical devices professionals who struggling to find classification rules for their products. I request you to please go through the document, If I missed anything, please update in the excel sheet.

Regards
S. Subramaniam
 

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MIREGMGR

#2
Re: European Medical Devices Classification “MEDDEV 2. 4/1 Rev. 9 June 2010”

It might be worth adding a note with Rule 1 pertaining to the definition of "accessory" in MDD Article 1, Part 2(b).

Accessories may have the Part 2(b)-defined relationship to anything with which they're used, irrespective of whether that item is made by the provider of the accessory-object or not. Basically, if a product is used in proximity to a medical device and its use is somehow related to that of the medical device, even if it does not meet any of the Rule conditions it probably is subject to the MDD as an accessory.

We have recently had a new capital-equipment product determined by our NB to be subject to the MDD, even though it clearly is not a medical device, because it is an accessory to other items in the clinical environment.

That was actually the classification outcome that we wanted, but I was surprised that we were able to accomplish it as it seems legally problematic to me. Per that perspective, everything making up a clinical setting, potentially within a relatively large radius, might be considered to be subject to the MDD.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: European Medical Devices Classification “MEDDEV 2. 4/1 Rev. 9 June 2010”

It might be worth adding a note with Rule 1 pertaining to the definition of "accessory" in MDD Article 1, Part 2(b).

Accessories may have the Part 2(b)-defined relationship to anything with which they're used, irrespective of whether that item is made by the provider of the accessory-object or not. Basically, if a product is used in proximity to a medical device and its use is somehow related to that of the medical device, even if it does not meet any of the Rule conditions it probably is subject to the MDD as an accessory.

We have recently had a new capital-equipment product determined by our NB to be subject to the MDD, even though it clearly is not a medical device, because it is an accessory to other items in the clinical environment.

That was actually the classification outcome that we wanted, but I was surprised that we were able to accomplish it as it seems legally problematic to me. Per that perspective, everything making up a clinical setting, potentially within a relatively large radius, might be considered to be subject to the MDD.
Hi,

IMHO, this is an unnecessarily extreme interpretation. An "accessory" is not just something used "next", or "with" a device. It only becomes an accessory if it is specifically intended by its manufacturer to be used in a way that enables the medical device (to which it is an accessory) to be used as per the device's intended use (as prescribed by the device's manufacturer). My understanding is that the medical device would not be able to properly follow its intended use without the accompanying use of the accessory.

With lack of such explicit intended use, I would have found it hard to qualify a product an accessory, following the MDD article 1 part 2(b) definition.

Anyway, I'm not a NB... :lol:

Cheers,
Ronen.
 
M

MIREGMGR

#4
Re: European Medical Devices Classification “MEDDEV 2. 4/1 Rev. 9 June 2010”

An "accessory" is not just something used "next", or "with" a device. (...) My understanding is that the medical device would not be able to properly follow its intended use without the accompanying use of the accessory.
The MDD definition:
[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]accessory[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]means an article which whilst not being a device is
intended specifically by its manufacturer to be used together with
a device to enable it to be used in accordance with the use of the
device intended by the manufacturer of the device

is anything but clear. Certainly there's not enough there for us to disagree with our NB and AER.

Does your "would not be able" comment appear in a guidance or some other authoritative written document? What is the basis for your understanding...do you know of a precedent-classification instance in which such an interpretation was used?

This is kind of a big deal for us...there's a lot of money on the line, and relationships with some very large corporate OEM-distributors. If our NB and AER have taken an untenable path on this, I'd very much like to figure it out sooner rather than later.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: European Medical Devices Classification “MEDDEV 2. 4/1 Rev. 9 June 2010”

The MDD definition:

is anything but clear. Certainly there's not enough there for us to disagree with our NB and AER.

Does your "would not be able" comment appear in a guidance or some other authoritative written document? What is the basis for your understanding...do you know of a precedent-classification instance in which such an interpretation was used?

This is kind of a big deal for us...there's a lot of money on the line, and relationships with some very large corporate OEM-distributors. If our NB and AER have taken an untenable path on this, I'd very much like to figure it out sooner rather than later.
:(

Sorry to let you down mate, but I can't point out the documentation you're looking for. Exactly as I wrote - this is my understanding, MHO etc., and is only based on the MDD definition itself (I think the key word in it is ENABLE - to make something otherwise unable, able) and some general reading here and there.

However these questions are pertinent and I would direct them to the NB! luckily NB's are not state authorities, they are commercial entities (just like your company, I assume) with some regulating power allocated to them. As they are looking to be profitable themselves, they shouldn't ignore the same need of their customers (subject to following the regulation of course). I'm sure you know just like me that there are many NBs around (and just as many interpretations and levels of scrutiny), and NBs can be replaced if they grow too harsh, so unlike with the FDA, TGA etc. I think you're quite well positioned to require their accountability over their decisions.

Best of luck and please keep us posted with the results :agree1:

Cheers,
Ronen.
 
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