Medical Device Cart

#1
Hi Everyone, Im hoping to solicit clarification on the EUMDR requirements for using a cart with a patient monitor. The cart simply holds the monitor and allows the caregiver to become mobile with the parent device. We are currently looking to have a cart supplier provide us with evidence of compliance to the Machine directive and a CE marking.

Question: Is compliance to the Machinery Directive, CE Marking (from the supplier) and Validation of the cart with the parent device (from the device manufacturer) acceptable to satisfy the EUMDR requirements?

Our organization is considering treating this as a Class 1 and holding the DHF for the cart and essentially owning the cart. Taking ownership of the cart would induce a very large amount of internal compliance work. My gut tells me this is too much and its acceptable that the ownership of the cart reside with the cart manufacturer and not with owner of the parent device.

Help is appreciated
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
A few thoughts:
1. The machinery directive is unlikely to be applicable unless the cart is motorised.
2. The cart is likely to be an accessory to a medical device, but determining that requires close examination of the intended uses of both the cart and the carried monitor, as expressed by their respective manufacturers of record (i.e. those under whose names the products are placed on the market).
3. It's a little difficult to comment on the situation because it's a little unclear what the supply/commercial chain of events is. Could you please chart the logistic and ownership steps that the cart goes through from being completed at the factory and up to final use?
4. CE marking involves making sure that all the applicable CE marking directives are satisfied.
 

Watchcat

Trusted Information Resource
#3
It's a little difficult to comment on the situation because it's a little unclear
Agreed. Based on the information provided, what first came to my mind is that, when one company wants to hold the DHF for another company's product, it might be more interested in controlling the DHF than in just holding it. This made me wonder whether changes in the cart might reasonably be expected to affect the performance of the patient monitor, and/or on the suitability of the cart for use with the monitor.

My other thought is that, in simply supporting the cart and enabling the caregiver to move the monitor horizontally, the cart could have essentially the same relationship to the patient monitor as an elevator, which simply supports the cart and enables the caregiver to move the monitor vertically. If the relationship is not the same, perhaps the answer lies in the differences.
 
#4
A few thoughts:
1. The machinery directive is unlikely to be applicable unless the cart is motorised.
Thank you for your response :)

Its interesting to hear that you think that the Machinery Directive would only apply if the cart was motorized. The cart is NOT motorized.

2. The cart is likely to be an accessory to a medical device, but determining that requires close examination of the intended uses of both the cart and the carried monitor, as expressed by their respective manufacturers of record (i.e. those under whose names the products are placed on the market).
We see it as an accessory.

3. It's a little difficult to comment on the situation because it's a little unclear what the supply/commercial chain of events is. Could you please chart the logistic and ownership steps that the cart goes through from being completed at the factory and up to final use?
I cannot provide that level of detail. The cart company manufactures the cart to all sorts of other device manufacturers so it is a commercially used product, not unique to our device.

4. CE marking involves making sure that all the applicable CE marking directives are satisfied.
 
Last edited by a moderator:

dgrainger

Trusted Information Resource
#5
It doesn't appear to be machinery as it isn't driven, nor does it appear to be an accessory to the device as it doesn't seem to enable' the functionality of the device. It's just a stand.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
nor does it appear to be an accessory to the device as it doesn't seem to enable' the functionality of the device. It's just a stand.
So it seems at face value, but we don't know that. Not enough information was provided. For example, carts sometimes include power supplies. Enable / doesn't enable depends on the definitions made by the manufacturers of record, and those aren't available to us either.

Additionally, the MDR definition contains to options ("or") for a product to be an Accessory to a Medical Device:

specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s)
or
specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)


The first option doesn't include the word functionality (you wrote: "enable' the functionality of the device"). Is the monitor intended by its manufacturer to be used while sat on the floor? On the patient's bed? On the patient's bedside cabinet? I guess probably not, but the fact is we don't know yet. Moreover, it sounds like the monitor is intended to be relocateable with the patient - so how is it intended to be relocated in the absence of a cart (or similar)? Is it light enough to be carried by the caregiver? We don't know.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#7
I cannot provide that level of detail. The cart company manufactures the cart to all sorts of other device manufacturers so it is a commercially used product, not unique to our device.
If the cart is indeed deemed an Accessory to a Medical Device, all the MDR becomes relevant to it just like to a medical device. The important (but subtle) point is that an object can officially become a medical device (or an accessory to one) without physically changing anything in the object, simply by assigning a certain intended use to it. The entity who owns it (i.e. under whose name it's sold in the EU) when that assignment occurs becomes fully responsible for MDR compliance. In your case it sounds like it can be either the actual manufacturer or your company. It all depends on the intended uses (of both the monitor's and the cart's) as you and them indicate them. It's important to note that the intended use may be changed through implication by some actions (e.g. selling the cart for a specific use), even without changing formal declarations, labelling etc.

How is the actual manufacturer currently handling the issue with their other customers? Are they in compliance with the MDR (or planning that)? If they're fine with taking that responsibility in your case, you can build your case such that you and them would be aligned with the regulation, but for them it might be an added burden. Sounds a little like a zero sum game - either they take the burden or you...
 
Last edited:

Watchcat

Trusted Information Resource
#8
The cart company manufactures the cart to all sorts of other device manufacturers so it is a commercially used product, not unique to our device.
It seems like this sentence should read either:
"The cart company sells the cart to all sorts of other device manufacturers...
or
"The cart company manufactures the cart to all sort of other device manufacturers' specifications..."

If you meant to say the former, then, I agree, it would not be unique to your device. However, this doesn't seem consistent with your original statement about "essentially owning the cart."

It you meant to say the latter, then I would think any cart manufactured to your unique specifications would be unique to your device. In this context, "essentially owning the device" makes more sense to me. In fact, it would then seem that your company might have always "owned" the cart from a legal perspective, and the other company is just your contract manufacturer.
 
Last edited by a moderator:

Watchcat

Trusted Information Resource
#9
It's just a stand.
Yes, sometimes a cigar is just a cigar, and sometimes "our device is exactly the same as the predicate." But most of the time, it is "Well, except for X." "Oh, and also Y." "Did we forget to mention Z? Oops."

Color me skeptical, especially if something normally so mundane and non-proprietary as the basic supply/commercial chain of events is some kind of corporate trade secret. And why would anyone want to "own the DHF" on "just a stand"? Do they want to own the DHF on "just an elevator," too? Seems unlikely.
 
Last edited:
Thread starter Similar threads Forum Replies Date
J Determining Fuse Rating and Labeling - Medical Device Crash Cart IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 2
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
B How to classify a medical device based on MDR? EU Medical Device Regulations 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
I How to classify a medical device based on FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S The US FDA requirements on Disposal of a medical device US Food and Drug Administration (FDA) 1
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
U Medical Device Design finalization testing ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Requirements for Medical Device Label Reconciliation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Medical Device Registration in the UAE MoH Other Medical Device Regulations World-Wide 2
JoCam Medical Device Distribution in the UK EU Medical Device Regulations 6
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Direct to customer export of medical device (class I: prescription lenses + frame) US Food and Drug Administration (FDA) 2
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T First 510(k) submission - Class II software as medical device US Food and Drug Administration (FDA) 1
M Mexico Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
Q 21 CFR 821 Medical Device Tracking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Discontinuation of the Predicate Medical Device Medical Device and FDA Regulations and Standards News 1
H Online courses/program for medical device regulation EU Medical Device Regulations 4
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 15
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
M Status of Medical Device Regulations in UK Post-Brexit Other Medical Device Regulations World-Wide 8
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
S How to register class IIA medical device accessories EU Medical Device Regulations 1
Similar threads


















































Top Bottom