Device Master Records for a Contract Manufacturer

SGquality

Quite Involved in Discussions
#1
In reading the DMR requirements, it is definitely the customer responsibility to prepare and maintain a DMR.

But is a Contract Manufacturer required to prepare a DMR based on the manufacturing process and including all information relating to Customer Drawings, Specifications, List of SOPs and so on ?
 
Elsmar Forum Sponsor
V

Vthouta

#2
We are a contract manufacturing company building electronic pcb's for our medical customers. We have not been told by any of our multinational top tier medical OEM's to maintain DMR, but we have to retain the files as per the ISO 13485 for example job routers and if an existing assembly or product is called off by the medical OEM, we archive all the files i.e. specifications, drawings and work instructions as per the clause 13845.

Vik
 

Ronen E

Problem Solver
Staff member
Moderator
#3
In reading the DMR requirements, it is definitely the customer responsibility to prepare and maintain a DMR.

But is a Contract Manufacturer required to prepare a DMR based on the manufacturing process and including all information relating to Customer Drawings, Specifications, List of SOPs and so on ?
Hi,

1. Please note that (based on precedents) FDA might hold the Contract Manufacturer as the primary regulatory-wise responsible party, and thus part 820 would apply in full.

2. Even if not mandated by the regulation directly, the requirement for a DMR (or the equivalent) might be transferred to the CM from the Spec Developer (the client) through contract. Often, the client would not have the ability to devise and maintain a full DMR, and the CM would not be interested in sharing all the device specs / manufacturing specs that the client would need for a compliant DMR.

3. It's most likely, if a CM serves the medical devices industry, that they already have all the records (and supporting procedures) that would make up a compliant DMR, whether they call it that or not. True, if no initiative is taken in that direction it might be cumbersome to immediately present or collect 100% of those records at any given moment, but probably not impossible if given a bit of time and attention. That (already existing) collection might be considered "the DMR" (albeit a deficient one) if no other arrangement is intentionally made.

Cheers,
Ronen.
 
P

PBuckley

#4
Hi,

1. Please note that (based on precedents) FDA might hold the Contract Manufacturer as the primary regulatory-wise responsible party, and thus part 820 would apply in full.

2. Even if not mandated by the regulation directly, the requirement for a DMR (or the equivalent) might be transferred to the CM from the Spec Developer (the client) through contract. Often, the client would not have the ability to devise and maintain a full DMR, and the CM would not be interested in sharing all the device specs / manufacturing specs that the client would need for a compliant DMR.


Cheers,
Ronen.
Heartily agree with Ronen on these points. As a specification developer who has contracted out manufacturing to a 3rd party, we rely on the third party to maintain DMR's using drawings, specifications, and procedures we supply to them, and DHF's showing manufacture and final release of finished product. They have agreed to provide this documentation to us upon request, (within a reasonable time frame of course). This is accomplished through contract, negotiated and agreed to by both parties. :agree:

Paul
 
Thread starter Similar threads Forum Replies Date
rob73 Digital DMF (Device Master File) Records EU Medical Device Regulations 3
I DMR (Device Master Records) and similar for standalone software device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Question regarding Device Master Records & Specification Developers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M DMR - Device Master Records - What is the best way to structure the DMR 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 55
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
D Device Master Record (DMR) checklist ISO 13485:2016 - Medical Device Quality Management Systems 1
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R No design history file or device master record ISO 13485:2016 - Medical Device Quality Management Systems 5
Sam Lazzara Medical Device File (MDF per 13485:2016 4.2.3) versus FDA Device Master Record (DMR) ISO 13485:2016 - Medical Device Quality Management Systems 3
M Medical Device Master File - We are a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 10
R Are DMR (device master record) and DHR (device history record) inspected by FDA or audited by an NB ISO 13485:2016 - Medical Device Quality Management Systems 9
S Foreign Manufacturer and DMR - Who keeps the DMR (Device Master Record)? ISO 13485:2016 - Medical Device Quality Management Systems 2
S DMR (Device Master Record) for Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 3
S DMR (Device Master Record) Management and Index questions Other US Medical Device Regulations 18
P DMR (Device Master Record) for Class I and Class II Dental Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
I Device Master Record Requirements for Component Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B DMR (Device Master Record) For Contract Manufacturers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
C When to submit a 510(k)? After the DMR (Device Master Record) is finished? Other US Medical Device Regulations 4
U What is a Medical Device "Master Item File"? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Contents of DMR (Device Master Record) when manufacturing is by 3rd party 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A DMR (Device Master Record): What is meant by these words - Software Specifications? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
D DMR (Device Master Record) Index as a Controlled Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
T Device Master Record For Medical Device Accessories ISO 13485:2016 - Medical Device Quality Management Systems 2
T Japan Master Files for Device materials? Japan Medical Device Regulations 5
E Need help establishing a DMR (Device Master Record) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 50
W Protecting Proprietary Information - Medical Device Master Files US Food and Drug Administration (FDA) 9
P Device Master Record requirements - wrong approach? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Format of Device Master Record (DMR) for Combination Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Device Master Record (DMR) that was compiled by another company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
W Update DHF (Device History Record) when DMR (Device Master Record) changes? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
M Contract Manufacturer - Technical/Device Master File Responsibility ISO 13485:2016 - Medical Device Quality Management Systems 10
C Is Site Master File necessary for a European Medical Device Manufacturer (class III)? ISO 13485:2016 - Medical Device Quality Management Systems 5
W DMR (Device Master Record) Revision Requirements? FDA GMP Manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S DMR Index - Can someone share their Device Master Record Index structure or format? ISO 13485:2016 - Medical Device Quality Management Systems 15
B ISO 14971 replaces EN 1441 - Risk Analysis and Technical Files/Device Master Files ISO 14971 - Medical Device Risk Management 17
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 1
C Question on KAFO (Knee Ankle Foot Orthosis device) classification CE Marking (Conformité Européene) / CB Scheme 0
G FDA clearance for a device that can't be used clinically (at present) Other US Medical Device Regulations 5
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 8
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
A Declaring Conformity with MDR Article 120(3) for an MDD Legacy Device EU Medical Device Regulations 1
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom