Audio Transducer as Class I Medical Device

C

cjaldous

Starting to get Involved
#1
#1
I am trying to rationalize our device as Class I.

The device, an insert earphone, is an accessory for an audiometer. Audiometers are generally Class IIa.
The device is used inside the ear canal, is intended to touch only intact skin, and is commonly in contact for less than 1 hour (transient use).
Regardless, it seems that rule 5 would make this device Class IIa since it connects to an audiometer.

Does the fact that it is an accessory change the way I can rationalize it?

Also, the MHRA has "Auditory Testing Headphones and Accessories" (code Z172), and "Electrodes/Transducers and Accessories" (code C2) as Class I devices.

Does this strengthen my Class I rationalization?
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
C

cjaldous

Starting to get Involved
#2
#2
Ok. I think I answered part of this myself. The following definition would seem to say that since there is more than a "remote link" between the transducer and medical use, that the transducer would be covered by 93/42 and therefore would be a Class IIa since it is invasive and connects to an audiometer. Correct?

According to MEDDEV 2.1/1 (1994)

1.2 Definition of accessory

The question whether a product is a "device" or a "accessory" has not
practical consequence. Following article 1(1) of Directive 93/42/EEC,
"accessories shall be treated as medical devices in their own right". Therefore
the main question is whether a product with a rather remote link to a
medical use can still be considered as "accessory" (article 1(2)b) and as a
matter of consequence is covered by the directive.
 
Ronen E

Ronen E

Problem Solver
Moderator
#3
#3
Based on the information provided, the subject earphone is class IIa or higher (rule 5 applies).

The MDD takes legal precedence over any associated guidance.

Cheers,
Ronen.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
W Alarm “AUDIO PAUSED” of infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
Marc How Lucas Modernised Audio in Film After Work and Weekend Discussion Topics 0
S Do you use audio-visual streaming during FDA inspection? US Food and Drug Administration (FDA) 3
S Quality / 9001/ Six Sigma Audio CD Recommendations? Training - Internal, External, Online and Distance Learning 1
B What directive applies? Audio/Visual Medical Devices CE Marking (Conformité Européene) / CB Scheme 4
B Audio Cable Classification - Class 2 wiring for the speaker outputs TL 9000 Telecommunications Standard and QuEST 11
S Computer Screen Video Capture and Recording Software with Audio After Work and Weekend Discussion Topics 5
G FMEA Severity Ranking for an Automotive Audio System FMEA and Control Plans 9
H Does Welding of the Metal Housings for Audio Equipment Need Validation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Marc Sony Music Audio CD Anti-Piracy Software Triggers Uproar World News 5
Marc Streaming Audio on the Internet - 10 Years Old - Real Audio After Work and Weekend Discussion Topics 0
C Six Sigma Defects per Unit (DPU) - Manufacture Of Computer And Audio Parts Assembling Six Sigma 2
T Thermometers and Thermocouple or Transducer's require MSA? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
M Pinout of Keller PAA-15 Pressure Transducer General Measurement Device and Calibration Topics 1
W Pressure Transducer Calibration Standards General Measurement Device and Calibration Topics 6
V High Pressure Gauge Transducer (30,000 PSI) / Transmitter Procedures General Measurement Device and Calibration Topics 5
H Calibration uncertainty with torque transducer Measurement Uncertainty (MU) 6
C Pressure Transducer - Number of Calibration Test Points General Measurement Device and Calibration Topics 12
D Correct form to amend medical devices class III (IMDRF vs Form 2016) Canada Medical Device Regulations 0
O Is a Certified 13485 for class I devices needed ISO 13485:2016 - Medical Device Quality Management Systems 2
E Insulation class II device with metal enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
V Tendon Harvestor (Class Im or Class I) EU Medical Device Regulations 1
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
V SaMD/MDSW - Class I - CE Mark CE Marking (Conformité Européene) / CB Scheme 1
MaHoDie Is it possible to assign medical software to security class A (according to IEC 62304)? EU Medical Device Regulations 5
F Class A - sterile vs non sterile EU Medical Device Regulations 5
B Painted surface of a protective Class I equipment. CE Marking (Conformité Européene) / CB Scheme 1
B Post-Market Surveillance Requirements for Canada - class IIa/IIb device Canada Medical Device Regulations 1
N Direct Part Marking of the "CE" symbol- Class I Device EU Medical Device Regulations 1
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
T PMCF Surveys for Class II a devices: basic requisites EU Medical Device Regulations 0
T PMCF Surveys for Class II a devices : basic requisites CE Marking (Conformité Européene) / CB Scheme 0
D Conformity Assessment for a System Class IIb EU Medical Device Regulations 0
F Philippines: Old Certificate of exemption for Class B device and new LTO. How to proceed? Other Medical Device Regulations World-Wide 0
R Class I MDSW CE Mark CE Marking (Conformité Européene) / CB Scheme 6
N Class III PMA shelf life extension US Medical Device Regulations 2
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
A Class 2a CE Mark Regulatory Pathway CE Marking (Conformité Européene) / CB Scheme 1
normhowe Surprising shoe policies for Class 7 Cleanrooms US Medical Device Regulations 5
L Class I under MDD EU Medical Device Regulations 1
C Legacy device under Class A sterile devices EU Medical Device Regulations 0
N FDA class 1 US Food and Drug Administration (FDA) 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
T Testing for proving food safety on USP class vi material RoHS, REACH, ELV, IMDS and Restricted Substances 0
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom