Audio Transducer as Class I Medical Device

#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?
 
Elsmar Forum Sponsor
#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

Problem Solver
Staff member
Moderator
#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.
 
Thread starter Similar threads Forum Replies Date
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
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
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
D Adding a Class I to a sample box Canada Medical Device Regulations 5
T Class A PRTD beyond 300°C General Measurement Device and Calibration Topics 0
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Protective earth for Class I ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
A AQL - How to count samples with defects for each defect class AQL - Acceptable Quality Level 17
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
A Medical Device Vigilance decision tree for Japan for class 2 devices. Japan Medical Device Regulations 1
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
W Seeking Guidance Verification Test Strategy for Class B Medical Devices IEC 62304 - Medical Device Software Life Cycle Processes 1
S Shipment of a CE Approved Class III Device to the EU Member States Other US Medical Device Regulations 1
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
Edward Reesor EU Authorized Representative for a Class I Medical Device CE Marking (Conformité Européene) / CB Scheme 11
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1

Similar threads

Top Bottom