Medical Device Accessory Responsibility

#1
Hi All, I really enjoy this forum! I have a scenario that I would appreciate some guidance on.

Customer sells class 1 medical device, and a Supplier sells a class 1 medical device accessory (single-use and sterilized in packaging) that works with the Customer’s medical device.

Associated note: the Supplier designed the accessory, owns the design, and already sells the accessory to many different customers. They update the labeling to reflect customers' information as applicable to the specific customer's medical device.

The Customer wants to purchase the supplier’s accessory, have the supplier place the Customer's name and information on the label and packaging to market and sell for use with their medical device. There will be no indication or reference to the supplier information, the accessory will seem as though it is the Customers product entirely. Although, the label will indicate “manufactured for” on the label.

Question: Since the Customer did not design the accessory, and keeping in mind the accessory is sterile packaged, what from a regulation, documentation, and compliance standpoint does the Customer need to do in their system to approve and properly release the device? Examples:
  • Even though they did not design, do they need to identify user needs, input, outputs, (performance) verification, and validation activities specific to how the accessory will be used with their device?
  • Is a Risk plan, assessment, or report required? Or can a concise evaluation memo be used?
  • Any package performance testing required?
  • Whose UDI should be on the labeling? I would assume the Supplier to be the Device labeler and their UDI would apply but am unsure.
  • Is the Customer considered a Distributor or do they need to register and list as manufacturer?
  • Who handles complaints and is most responsible if device accessory fails?
  • Anything else I am missing?
Any help would be greatly appreciated!
 
Elsmar Forum Sponsor

IZAKK

Registered
#2
Hi all, just wondering if this question is in the correct location. Could someone let me know if I posted this correctly? This is my first time posting. Any help would be appreciated! Thanks!
 

Sidney Vianna

Post Responsibly
Leader
Admin
#3
Hi all, just wondering if this question is in the correct location. Could someone let me know if I posted this correctly? This is my first time posting. Any help would be appreciated! Thanks!
I moved the thread and changed the title. Feel free to request it to be moved elsewhere and another better title description
 

yodon

Leader
Super Moderator
#5
Lack of a response is probably indicative of fears over giving regulatory advice and especially with limited information.

And count me in that group. But I have some questions that may at least trigger some discussion.

Can the device be used without the accessory?

Does the device risk file address use with the accessory?

And a couple of thoughts.

You say the accessory is delivered sterile so, yes, I would say there should be sterilization validation and sterile packaging validation.

If Customer's name goes on the labeling, they would, I believe, be considered the ones to receive and manage complaints.
 

IZAKK

Registered
#6
Lack of a response is probably indicative of fears over giving regulatory advice and especially with limited information.

And count me in that group. But I have some questions that may at least trigger some discussion.

Can the device be used without the accessory?

Does the device risk file address use with the accessory?

And a couple of thoughts.

You say the accessory is delivered sterile so, yes, I would say there should be sterilization validation and sterile packaging validation.

If Customer's name goes on the labeling, they would, I believe, be considered the ones to receive and manage complaints.
Hi, and thanks for the response! Please see my comments.

Can the device be used without the accessory? Device can be used without the accessory.

Does the device risk file address use with the accessory? Yes, it does.

And a couple of thoughts.

You say the accessory is delivered sterile so, yes, I would say there should be sterilization validation and sterile packaging validation.

The packaging is validated by the supplier and is sold that way. Do you think a certification of sterilization from the supplier would be acceptable or is having the actual reports on file necessary.

If Customer's name goes on the labeling, they would, I believe, be considered the ones to receive and manage complaints.

Thanks!
 

yodon

Leader
Super Moderator
#7
The packaging is validated by the supplier and is sold that way. Do you think a certification of sterilization from the supplier would be acceptable or is having the actual reports on file necessary.
Possibly. Bear in mind that you are ultimately responsible FDA would be well within their rights to ask for the sterilization validation documentation. Do the due diligence to ensure that information is available and compliant.
 

IZAKK

Registered
#8
Possibly. Bear in mind that you are ultimately responsible FDA would be well within their rights to ask for the sterilization validation documentation. Do the due diligence to ensure that information is available and compliant.
I agree, and thanks for the feedback!
 
Thread starter Similar threads Forum Replies Date
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
T Classification Accessory Software medical device EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 8
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
E Under MDR is a medical workstation a medical device or an accessory? EU Medical Device Regulations 5
D Software as an accessory to a Class I medical device EU Medical Device Regulations 4
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
N Medical Device Accessory Classification - Software as a Medical Device Other Medical Device Regulations World-Wide 5
M Commercial tablet as an "accessory" for a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
S The difference between a Medical Device Accessory and Component Canada Medical Device Regulations 2
F Risk Analysis of a Medical Device Accessory ISO 14971 - Medical Device Risk Management 4
M New Medical Device Accessory with New Function - Is this a major change? Other Medical Device Regulations World-Wide 3
JoCam Non-medical device accessory for a medical device EU Medical Device Regulations 27
I Class I Medical Device Accessory with Actual Risk EU Medical Device Regulations 7
shimonv Feeler Gauge as a Medical Device Accessory EU Medical Device Regulations 3
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
shimonv EU classification for a Medical Device Accessory EU Medical Device Regulations 16
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
P EMC requirements for an accessory to a medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
somashekar FDA proposal on Medical Device Accessory Risk Assessment Other US Medical Device Regulations 15
R Medical Device and Accessory Establishment Registration and Listing Query Other US Medical Device Regulations 7
D Software as a Medical Device Accessory Software Quality Assurance 2
K Standalone software - an accessory to medical device? EU Medical Device Regulations 4
K Importance of Medical Device Accessory Design Controls Other US Medical Device Regulations 4
R Regulation Process for Add on Accessory to an Existing Medical Device Other US Medical Device Regulations 1
Q FDA Medical Device Accessory Packaging Requirements US Food and Drug Administration (FDA) 12
Y Medical Device Accessory Labeling Requirements Other Medical Device Regulations World-Wide 1
D Class I and Class II Medical Device Accessory Design Control Requirements US Food and Drug Administration (FDA) 3
Z IEC 60601-1-2 for very simple Medical Device Accessory IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K USB Charger Adapter/USB Cable - A Medical Device Accessory? EU Medical Device Regulations 2
S Definition Medical Device Accessory - FDA Definition of Accessory Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
J Packaging and User Manual for Medical Device and Accessory CE Marking (Conformité Européene) / CB Scheme 3
S OEM Supplier with ISO 9001 Labels Medical Device Accessory ISO 13485:2016 - Medical Device Quality Management Systems 3
R Dialysis Machine is CE Marked as a Medical Device - Accessory or not? EU Medical Device Regulations 4
D Requirement for Expiration Date on Medical Device Accessory Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A Software contained in a Medical Device Accessory IEC 62304 - Medical Device Software Life Cycle Processes 3
M Defining what is a Medical Device Accessory and what isn't - Much Confusion EU Medical Device Regulations 8
Y How can an Optional Accessory of a Medical Device be sold alone? Other US Medical Device Regulations 5
T Definition Servicing Activities - Definition - Medical device accessory manufacturer Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
C Medical Device "accessory" - Blood pressure monitor (BPM) power supply EU Medical Device Regulations 7
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
S Medical device other market Medical Device and FDA Regulations and Standards News 1
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 1
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 4
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom