Manufacturers Obligations for Medical Device Servicing and/or Repair

S

SarahB1

#1
Hi,
I wonder if anyone can help me please? I am new to medical devices that need service and/or repair and just need some clarification on the requirements.

We manufacture and either sell or lease medical devices. Where they are leased, part of that agreement is that we, or our approved supplier, service the equipment in accordance with our instructions (every 6 months). We keep records of all service and maintenance done on the equipment.

Where the device is sold, through a distributor, we have no such agreement, and they are free to choose their own supplier for service. We provide the service manual and requirements for service. At present we do not get copies of the service reports etc. Do we need to?

Thanks
 
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Candi1024

Quite Involved in Discussions
#2
Re: Manufacturers obligations for servicing

No, you do not. At least, we do not, and it has never been mentioned as a requirement. You have no control over the service supplier, and the buyers have no obligation to send you service reports.
 

yodon

Staff member
Super Moderator
#3
Re: Manufacturers obligations for servicing

No, you do not. At least, we do not, and it has never been mentioned as a requirement. You have no control over the service supplier, and the buyers have no obligation to send you service reports.
Interesting question and equally interesting response. Can't argue one way or the other but I would like to ask a few follow-on questions.

21 CFR 820.200 states that the manufacturer (b) must analyze service reports and (c) determine if the report constitutes a complaint. (In 13485:2016 analysis of service reports has been added to 8.4 Analysis of Data, by the way). Is there a risk that you might not have this data?

In more general terms, if the distributor's service supplier enables a device to go back to a user and some harm is realized as a direct result of incorrect service, wouldn't there be a liability concern for the manufacturer of record?
 

Candi1024

Quite Involved in Discussions
#4
Re: Manufacturers obligations for servicing

Interesting question and equally interesting response. Can't argue one way or the other but I would like to ask a few follow-on questions.

21 CFR 820.200 states that the manufacturer (b) must analyze service reports and (c) determine if the report constitutes a complaint. (In 13485:2016 analysis of service reports has been added to 8.4 Analysis of Data, by the way). Is there a risk that you might not have this data?

In more general terms,if the distributor's service supplier enables a device to go back to a user and some harm is realized as a direct result of incorrect service, wouldn't there be a liability concern for the manufacturer of record?
We have actually had this happen. Unfortunately we have no way of controlling who is doing the service. IMO it shouldn't be allowed.
 
S

SarahB1

#5
Thanks for the information and responses. Where possible we try to get copies of the service reports, but sometimes we can't get them, and sometimes they are in a different language.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: Manufacturers obligations for servicing

21 CFR 820.200 states that the manufacturer (b) must analyze service reports and (c) determine if the report constitutes a complaint.
The thread has been opened in the forum "EU medical device regulations", so for the time being I'm going to assume that part 820 is not the driver of concern. Further, I understand the focus of section 820.200(b) to be the application of appropriate statistical methodology according to 820.100; ie it doesn't mandate the collection of service reports but discusses the analysis of available reports, when/if available. Section (c) starts "Each manufacturer who receives a service report...", so if reports are not received it's simply N/A, in my understanding.

By the way, the FDA has initiated a consultation process regarding post-market maintenance activities. Big portions of that aspect (ie repairs) have been de-facto left in a grey area for many years. I suppose that once the consultation is over some changes can be expected.

(In 13485:2016 analysis of service reports has been added to 8.4 Analysis of Data, by the way).
ISO 13485:2016 8.4(f) requires that analysis includes input from service reports as appropriate. Even if deemed appropriate, it merely requires "input from service reports" and doesn't spell out a requirement to collect all service reports.

According to s. 0.2, the following should be asked:
1. Is analysing inputs from service reports necessary for product to meet requirements?
2. Is analysing inputs from service reports necessary for compliance with regulatory requirements? [This is probable under the EU post-market vigillance requirements.]
3. Is analysing inputs from service reports necessary for allowing the manufacturer to take corrective actions? [This is likely as well.]
4. Is analysing inputs from service reports necessary for risk management?

If any one of the above is answered "yes", such analysis would be considered "appropriate", and thus expected under s. 8.4(f). If all are answered "no", an explanation must be documented.

In more general terms, if the distributor's service supplier enables a device to go back to a user and some harm is realized as a direct result of incorrect service, wouldn't there be a liability concern for the manufacturer of record?
Liability is a separate issue from "plain" medical devices regulations. In that regard I would recommend consulting a legal practitioner knowledgable in the laws that apply in the relevant territory.
 
Last edited:
S

SarahB1

#7
Thanks again,

So if I am keeping records of servicing that we do - or someone does on our behalf

I am analysing those reports to determine if there is a complaint/vigilance issue and acting upon that

I am collecting and analysing data from those to feed into my post marketing surveillance, continual improvement, CAPA and risk management programmes

Than I am covered

For the devices that are sold, and I don't have records of service, then I need to find another way obtaining data in the post market phase, any any data gathered from that process would likewise be analysed to feed into PMS, CAPA etc?
 

Marcelo

Inactive Registered Visitor
#9
Usually, service or a repair is a requirement defined by the manufacturer as an output of device design, meaning, if my device needs service or repair to maintain safety and effectiveness during the device lifecycle, then the service or repair becomes a requirement (that's why the old version of ISO 13485/9001 begun with: 7.5.1.2.3 Servicing activities - If servicing is a specified requirement,....).

So, if your device has service as a requirement, several expectation related to service, such as getting information from service and the like (if you perform the service yourself or not) usually begin to apply.
 

Access2hc

Involved In Discussions
#10
Hi,
I wonder if anyone can help me please? I am new to medical devices that need service and/or repair and just need some clarification on the requirements.

We manufacture and either sell or lease medical devices. Where they are leased, part of that agreement is that we, or our approved supplier, service the equipment in accordance with our instructions (every 6 months). We keep records of all service and maintenance done on the equipment.

Where the device is sold, through a distributor, we have no such agreement, and they are free to choose their own supplier for service. We provide the service manual and requirements for service. At present we do not get copies of the service reports etc. Do we need to?

Thanks
Hi,

Do you have a written agreement with your distributor?

Written or otherwise - there has to be agreements in place that quality related records shall be maintained. your distributor is an extension of your reach and your supply chain, as they are technically your supplier/service provider from a QMS perspective.

Service records are quality related records. Especially corrective (unscheduled) maintenance records, can turn out to be a product complaint, or even a safety related complaint.

Another thing to ensure, is that the distributors are obligated to have purchasing control (they are an extension of your company), hence their suppliers and especially ones that takes care of critical processes (such as servicing), needs a formal process from THEM to qualify these service providers.

Service records aside, they need to retain records for traceability in the event of a product recall, or corrective action in the field.

If I were you I'd try to put in place in a written agreement certain requirements for record keeping on the supply chain, product complaints, customer feedback and service records

hope it helps

Cheers,
Ee Bin
 
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