Custom Medical Device For Clinical Study

medwise

Involved In Discussions
#1
Hi Experts,

We are a small manufacturer based in Australia. A surgeon who is an inventor of a surgical instrument (class IIa) would like to use a custom made device manufactured for him for clinical publication.

Can someone please advise whether the custom made device can be used in clinical trials (surgeon to use custom device at his own practice) for publishing in scientific journals etc. Where do ethics committees come into play here or do they at all in this case? We know some surgeons publish new methods all the time under the declaration of Helsinki, without a separate committee (like NHMRC) assessment.

If the custom made device is cleared to be used by TGA on actual patients, why would a separate ethics committee process be needed to gather data in this case? The medical procedures are being done regardless during a surgeon’s practice.

Aim is to generate clinical data for registering this device with the TGA (ARTG entry) under conformity assessment and prepare CER using both literature from the comparator device and subject device.

Any advise will be greatly appreciated.

Thank you in advance.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
There are several routes to Clinical Investigations in Australia and not all of them involve going through the TGA. Also the level of involvement of ethics committees vary, depending on the specific situation. I can't answer responsibly based on the information you provided, and I also think that a public forum is not the best place for this kind of discussion. Please feel welcome to PM me if you'd like me to get more involved - If I had access to all (or most) of the relevant details I could point you in the right direction.
 
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
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
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
C If it's not a custom-made medical device... What is it? Clinician requests EU Medical Device Regulations 11
K Medical device procedure tray - Adding products in Custom packs Other Medical Device and Orthopedic Related Topics 3
pittmatj South Korea - Custom Medical Device Regulations Other Medical Device Regulations World-Wide 1
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
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 5
I Custom software services to be used by medical software ISO 13485:2016 - Medical Device Quality Management Systems 1
J Custom made medical devices - Wheelchairs EU Medical Device Regulations 6
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
T Requirements and standards for medical custom Electrical Connectors EU Medical Device Regulations 2
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
C Validating Custom adaptations of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 11
E Configurable/Custom made or accessories? EU Medical Device Regulations 0
J Gauge Suggestion: Specialty or Custom General Measurement Device and Calibration Topics 1
A Registration requirements for custom branded device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
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
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
W Product or Service? Custom Engineered Capital Equipment Manufacturer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
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
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
L Validation and documentation activities required for a custom-made software Qualification and Validation (including 21 CFR Part 11) 2
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
J Tailor-made or Custom Made Device? EU Medical Device Regulations 1
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

Similar threads

Top Bottom