Manufacturers Obligations for Medical Device Servicing and/or Repair

S

SarahB1

#1
#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
 
Paper to QMS ad
Elsmar Forum Sponsor
C

Candi1024

Quite Involved in Discussions
#2
#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.
 
Y

yodon

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

Candi1024 said:
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.
Click to expand...
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?
 
C

Candi1024

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

yodon said:
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?
Click to expand...
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
#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

Ronen E

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

yodon said:
21 CFR 820.200 states that the manufacturer (b) must analyze service reports and (c) determine if the report constitutes a complaint.
Click to expand...
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.

yodon said:
(In 13485:2016 analysis of service reports has been added to 8.4 Analysis of Data, by the way).
Click to expand...
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.

yodon said:
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?
Click to expand...
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
#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?
 
M

Marcelo

Inactive Registered Visitor
#9
#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.
 
A

Access2hc

Involved In Discussions
#10
#10
SarahB1 said:
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
Click to expand...
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
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Watchcat ISO 13485 for IVD (In-vitro Diagnostic Device) Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 9
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 0
dgrainger Informational MHRA updated guidance: Clinical investigations of medical devices – guidance for manufacturers Medical Device and FDA Regulations and Standards News 0
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
C ASL - Buying from unqualified manufacturers through qualified distributors Supplier Quality Assurance and other Supplier Issues 2
G Can calibrated device values be used instead of manufacturers spec? General Measurement Device and Calibration Topics 2
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
Q Purchasing requirements for Toll Manufacturers Manufacturing and Related Processes 1
F List of approved API manufacturers or Formulations manufacturers US Food and Drug Administration (FDA) 0
M Informational MHRA update – Medical devices: guidance for manufacturers on vigilance - June 2019 Medical Device and FDA Regulations and Standards News 0
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
I Japanese medical device recall requirements & procedure for foreign manufacturers Japan Medical Device Regulations 4
dgrainger EC-MDR Information for manufacturers guidance EU Medical Device Regulations 1
B Non Applications in ISO 13485:2016 for component contract manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 2
S Virtual manufacturers/OEM - CE/ISO requirements EU Medical Device Regulations 7
J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
P Requirements/guidance on what constitutes the Manufacturers "Address" EU Medical Device Regulations 7
M ISO TR 20416 Medical Devices - Post-Market Surveillance for Manufacturers Other Medical Device Related Standards 6
Ronen E Independence on Notified Bodies, inter alia of Manufacturers they Assess EU Medical Device Regulations 7
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
H Is Product Liability Insurance Compulsory for Medical Device Manufacturers? Other Medical Device Regulations World-Wide 2
JoCam Over-labelling the manufacturers name at the front of the device EU Medical Device Regulations 31
U Are all manufacturers required to set up eMDR system? Other US Medical Device Regulations 4
S Is FDA Establishment Registration for Bulk packaging Contract Manufacturers ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q FDA Requirements for Contract Manufacturers and OTC products US Food and Drug Administration (FDA) 4
A One Medical Device - Two Legal Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 5
DietCokeofEvil How is it that gage manufacturers are not required to be accredited? General Measurement Device and Calibration Topics 9
T Are Customers required to follow a Manufacturers Maintenance Schedule? ISO 13485:2016 - Medical Device Quality Management Systems 3
T Aerospace Manufacturers Label vs Certificate Quality Manager and Management Related Issues 6
H What is required to support changes to API Manufacturers in OTC Drugs? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
T IEC 62133 Certified Battery Manufacturers Other Medical Device Related Standards 3
C FDA requirements for Contract Manufacturers Document Control Systems, Procedures, Forms and Templates 1
T PPAP Requirements for Contract Manufacturers APQP and PPAP 4
M New Medical Device Contract Manufacturers Excise Tax Requirements US Food and Drug Administration (FDA) 8
Marc Guide To Inspections Of Medical Device Manufacturers - 1997 (06/08/2010) US Food and Drug Administration (FDA) 3
B DMR (Device Master Record) For Contract Manufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S Excipient Manufacturers - Supplier Risk Assessments when they refuse Customer Audits Supplier Quality Assurance and other Supplier Issues 5
K Applicability of ISO/TS 16949:2009 to Automotive Parts Manufacturers IATF 16949 - Automotive Quality Systems Standard 13
P CMC Decision 3 - Manufacturers Address Content Requirements EU Medical Device Regulations 4
D Distribution of a Kit composed of Piece Parts from several Manufacturers EU Medical Device Regulations 3
M Problems implementing ISO 13485 for Software-Only Medical Device Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 4
E FDA Quality Systems and DAMAS (Dental Appliance Manufacturers Audit Scheme) US Food and Drug Administration (FDA) 3
B FDA Requirements for Retaining Non-Conformance Tags (Medical Device Manufacturers) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G Are Component Manufacturers required to comply with ISO13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 4
Y Furniture manufacturers with ISO 9001:2008 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18

Similar threads

Top Bottom