Compatibility of a Class II exempted accessory with a Class III device

C

Corax

#1
Help - I'm confused in this matter!

We manufature FDA Class II exempted devices (MDD class IIa) and have an accessory for these devices that can changes a limited amount of settings within the main device - like a remote control with limited possibilities.

A company within the same Holding company manufactures class III implant devices.
They would like to state compatibility with our accessory meaning the accessory would have similar limited remote control possibility for their device - but would this make the accessory a class III device?

We would not change our labeling or intended use - the device would be sold as is (class II exempted). And we would not claim the compatibility.

They would not claim that this is an accessory to their device and would not sell our accessory, only state compatiblity and ensure proper compatibility testing as well as incorporate the compatibility with our accessory in their risk management.

How does this setup sound to you?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Their PMA will have to support/defend their direct compatibility claim and implied safety and efficacy claim by means of evidence.

The classification of your device as you sell it won't change. It however will have to be evaluated to Class III standards by them.

They would not claim that this is an accessory to their device [...] only state compatiblity
The latter has the same meaning as the former.
 
Thread starter Similar threads Forum Replies Date
K Class II Medical Device Compatibility Issue - Removal or Market withdrawal? US Food and Drug Administration (FDA) 2
R Compatibility studies for Combination Products - Europe Medical Device and FDA Regulations and Standards News 2
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
S Medical Device MRI Compatibility EU Medical Device Regulations 3
T Submitting MR Compatibility Data for 510(k) Cleared Device Other Medical Device and Orthopedic Related Topics 2
A Compatibility between MDD and MDR devices EU Medical Device Regulations 7
K Electromagnetic Compatibility Test IEC 60601-1-2: 2014 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
E IEC 60601-1-2 compliance for accessories - Electromagnetic compatibility of the ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Testing an equipment for MRI Compatibility Other US Medical Device Regulations 3
F EMC (Electromagnetic Compatibility) Conformity Charts - IFU Requirements Misc. Quality Assurance and Business Systems Related Topics 3
K Interpretation of IEC 60601-1-2 Electromagnetic Compatibility – Requirements & tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Plastic Compatibility tests with the contact of mucous membranes Other Medical Device Regulations World-Wide 3
B Titanium Implants MR (Magnetic Resonance) Compatibility Labeling US Food and Drug Administration (FDA) 2
R How to deal with the RM requirement of clause 17 Electromagnetic Compatibility? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
B Should EMC (Electromagnetic Compatibility) Testing be performed In-House CE Marking (Conformité Européene) / CB Scheme 10
J EMC (Electromagnetic Compatibility) Requirements - IEC 60601 3rd edition Clause 17 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Quality Assurance procedures for EMC (Electromagnetic Compatibility) Compliance CE Marking (Conformité Européene) / CB Scheme 4
J ISO 10993 (Biological Compatibility) Approved Materials US Food and Drug Administration (FDA) 23
Y MRI Compatibility - Electrical Device with a Video Display Other Medical Device and Orthopedic Related Topics 1
M Compatibility and Analogues Materials US Food and Drug Administration (FDA) 2
S Materials Compatibility in ISO 8185:2007 - Respiratory Tract Humidifiers IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Electrosurgery Emission Compatibility - Patient monitoring equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
somashekar Material Compatibility - PVC (halogenated polymers) and Santoprene (TPE) Manufacturing and Related Processes 4
D Definition What does cultural compatibility mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
S Construction Projects - Client & contractor - System compatibility issues Quality Manager and Management Related Issues 4
kedarg6500 "Cultural compatibility" EFQM excellence model Various Other Specifications, Standards, and related Requirements 1
4 Design help needed - Isoflurane compatibility with polymers - Anesthesia gas Design and Development of Products and Processes 6
S ISO14001 and TS16949 "Compatibility" vs. Audit Day Requirements IATF 16949 - Automotive Quality Systems Standard 7
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
D Electrical Medical Devices class I EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
L Class IIb devices marked EC according to the 93/42/CE - Portugal CE Marking (Conformité Européene) / CB Scheme 3
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 4
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom