Custom made medical device MDD vs MDR definition

#1
Hello everyone

My organization manufacturers sockets for patients who have lost a limb. The socket covers the patients residual limb, and is then fitted with other parts (including a hand or a foot) to create an artificial limb for the patient.

These sockets are individually made using a traditional lamination process by draping material over the cast of the patient's residual limb. As you can imagine this socket is made to the 'prescription' of the clinician and thus is a custom-made medical device, and doesn't bear a CE mark.

Two questions really....

1. Does the classification of custom made device change under the revised wording of MDD (custom made/mass produced)?

2. If we were to create 3D printed sockets, would this become a mass-produced device and hence require the application of the CE mark (class 1 device)

Thanks in advance for your thoughts.

James
 
Elsmar Forum Sponsor
#2
Hello everyone

My organization manufacturers sockets for patients who have lost a limb. The socket covers the patients residual limb, and is then fitted with other parts (including a hand or a foot) to create an artificial limb for the patient.

These sockets are individually made using a traditional lamination process by draping material over the cast of the patient's residual limb. As you can imagine this socket is made to the 'prescription' of the clinician and thus is a custom-made medical device, and doesn't bear a CE mark.

Two questions really....

1. Does the classification of custom made device change under the revised wording of MDD (custom made/mass produced)?

2. If we were to create 3D printed sockets, would this become a mass-produced device and hence require the application of the CE mark (class 1 device)

Thanks in advance for your thoughts.

James
Hello,

I have pretty much the same question regarding custom made orthotics devices, being fabricated from a cast.

Does anybody have any idea if they should still be considered as custom made devices or if it changes with MDR?

Thanks,
 

Ronen E

Problem Solver
Staff member
Moderator
#3
From the MDR:
‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
 

chris1price

Trusted Information Resource
#4
From my understanding, if the device is ordered by a physician and it is for a single named patient, then it is a custom-made device. How it is made is not important (cast, 3D machines etc) provided every one is different and for a unique patient.
 

chris1price

Trusted Information Resource
#6
Thanks, I wasn't aware of the IMDRF working group, this is good information. I am not surprised by the recommendations for documentation, although registration of devices may be more difficult. All things to bear in mind for the future.
 
#7
Thank you. Very interesting.

Until the recommendations of this workgroup gets implemented, does that mean that the rules stay pretty much the same between MDD and MDR? I read the definition of custom-made in both documents and it is very similar:

MDD
“(d) ‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.
Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user ►M5 shall not be ◄ considered to be custom made devices;”


MDR
“(3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;”
 
#8
On thing I also wanted to ask: I found that in the UK, there is pretty clear definition of what falls into custom-made vs non custom-made regarding orthotics and prosthetics devices. I can't post the link because I don't have 5 posts but I attached a pdf.

However, I didn't find any similar document for other countries. Do you know of some place where I could find a similar information for other countries, where they details what the MDD and MDR custom-made definition means specifically for orthotics and prosthetics products?
 

Attachments

#9
Hello,

Does anybody has an idea about that or an idea of who I could reach out to as a consultant? Preferably in the US.

Thanks!
 
Thread starter Similar threads Forum Replies Date
J Validity / outcomes measure for custom made medical device ISO 13485:2016 - Medical Device Quality Management Systems 2
J Custom made medical devices - Wheelchairs EU Medical Device Regulations 6
C If it's not a custom-made medical device... What is it? Clinician requests EU Medical Device Regulations 11
K DoC (Declaration of Conformity) for Custom Made Medical Devices EU Medical Device Regulations 1
F Registration Process Guidance for Custom-Made Medical Devices in South/Latin America Other Medical Device Regulations World-Wide 11
W Process Validation Training - Custom made Medical Device Design and Development of Products and Processes 4
M Custom-Made Medical Device Regulations and Registration in Argentina Other Medical Device Regulations World-Wide 5
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
J Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain EU Medical Device Regulations 4
L Validation and documentation activities required for a custom-made software Qualification and Validation (including 21 CFR Part 11) 2
J Tailor-made or Custom Made Device? EU Medical Device Regulations 1
I Custom software services to be used by medical software ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational ANVISA regulation for personalized/custom medical devices – RESOLUÇÃO – RDC Nº 305, DE 24 DE SETEMBRO DE 2019 Medical Device and FDA Regulations and Standards News 0
M Custom Medical Device For Clinical Study Other Medical Device Regulations World-Wide 1
B Sterilization of a custom medical device Other Medical Device and Orthopedic Related Topics 1
D Medical device development - Custom test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
G Reporting measurement uncertainty for custom items Measurement Uncertainty (MU) 2
R Custom Records and Quality Systems - Products that change frequently Other US Medical Device Regulations 3
T Requirements and standards for medical custom Electrical Connectors EU Medical Device Regulations 2
W Product or Service? Custom Engineered Capital Equipment Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
J ISO 9001:2015 - Clause 8.3 - Design in the Custom Manufacturing industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B IEC 60825-1 Class 3R Laser Off-The-Shelf or Custom Label Needed Other ISO and International Standards and European Regulations 3
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
D CE Marking for Custom Ordered Products Outside of the EU EU Medical Device Regulations 1
Q Process Control in High Volume Custom Electrical Enclosures Environment Statistical Analysis Tools, Techniques and SPC 4
V EO Sterilization of Drugs in Custom Convenience Kits Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
P Calibration of Custom Molds General Measurement Device and Calibration Topics 26
N Best Custom Software (To Track QMS & Processes) Provider Quality Assurance and Compliance Software Tools and Solutions 9
Fender1 Controlling Documents and Records in a Custom Weld/Fabrication Company Document Control Systems, Procedures, Forms and Templates 10
C Custom Device Regulations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Enclosure Flammability Rating of Molded-In Custom Color Liquid Concentrates IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J 3 Level Custom DOE in Minitab Using Minitab Software 3
J Custom Tools as SOUP? (Software of Unknown Provenance) IEC 62304 - Medical Device Software Life Cycle Processes 9
Q Using a Custom Process FMEA (PFMEA) Form FMEA and Control Plans 4
K Does ISO 22000 make sense for a Custom Injection Molder? Food Safety - ISO 22000, HACCP (21 CFR 120) 7
S Design Review: Can I exclude Custom Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
QMMike Surveys - Customer, Supplier, Custom... ect.... Quality Tools, Improvement and Analysis 1
R Custom DOE (Design of Experiments) Analysis in JMP Quality Tools, Improvement and Analysis 11
DanteCaspian Operator Break Coverage - Custom injection mould shop Manufacturing and Related Processes 9
DanteCaspian Dry Erase: Custom documents with laminate sheets Lean in Manufacturing and Service Industries 7
V Custom prototype checklist for Europe and FDA ISO 13485:2016 - Medical Device Quality Management Systems 1
M Calibration of Custom 6061 T6 Aluminum or Delrin Plastic Setup Tools?? General Measurement Device and Calibration Topics 5
B Quality Plan for ISO 9001-2000 - Assembly and Custom Build process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Process for receiving functions - COTS (commercial off the shelf) vs Custom parts. Document Control Systems, Procedures, Forms and Templates 6
J Measurement Uncertainty for Calibrating Custom Check Fixtures with a Portable CMM Measurement Uncertainty (MU) 3
C Validating Custom adaptations of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 11
M Commercial Quality Assurance Software (ie: SAP) vs. Custom Databases Quality Assurance and Compliance Software Tools and Solutions 12
R PVC Profile Extrusion - Custom Profile Extrusion company Manufacturing and Related Processes 4
A Tooling procedure for incoming custom built or commercial tooling and fixtures General Measurement Device and Calibration Topics 2
Similar threads


















































Top Bottom