Are Hearing Aids classified as Class I or Class II under EU?

12 questions to ask before buying a QMS
Elsmar Forum Sponsor
G

Guillaume Prom

#3
#3
I'm OK for class IIa, but I think that it's rule #9: active device that administer energy (where sound = energy).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
L Hearing Aids Labeled as "Used" - Canadian Regulations Canada Medical Device Regulations 2
C Jokes - An eldery patient gets hearing aids from a doctor Funny Stuff - Jokes and Humour 4
J Classification of Hearing Aids in Indonesia Other Medical Device Regulations World-Wide 1
V Pediatric Regulatory requirements for Hearing Aids Other ISO and International Standards and European Regulations 6
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Programmable CSF Shunts and Magnetic Field Interference with Implanted Hearing Devices – Letter to Health Care Providers Medical Device and FDA Regulations and Standards News 0
M Informational EU – Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) – Summary records Medical Device and FDA Regulations and Standards News 0
J Hearing Test Device Technology Licensee - Is ISO 13485 required? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Quality for Hearing Impaired Run Restaurant - Food Services - ISO9001 Principles Service Industry Specific Topics 1
A Custom impressions for hearing aides - What types of quality control processes? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Unit Testing as a quality tool - Interested in hearing other organizations experience Software Quality Assurance 3
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E RAC EU preparation aids - Tips on how to prepare for RAC EU exam Professional Certifications and Degrees 2
E BRAZIL: Regulatory requirements regarding aids for invalids Other Medical Device Regulations World-Wide 3
E TURKEY: Regulatory requirements regarding aids for invalids Other Medical Device Regulations World-Wide 2
D Medical Device Class Confimation - Device Aids in Physical Rehabilitation EU Medical Device Regulations 3
E PPAP Checking aids, what to do exactly? APQP and PPAP 5
optomist1 GD&T Study Aids - Medium to Complex Y14.5M Drawings Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
Marc AIDS Puzzle Solved By Computer Gamers World News 1
H Visual Aids - Documentation in our Specification System or Local Control? Document Control Systems, Procedures, Forms and Templates 2
T Document Control Training Aids Training - Internal, External, Online and Distance Learning 1
P Work Instructions/Job Aids in the Quality System Document Control Systems, Procedures, Forms and Templates 1
kmyers ISO Motivators - Ideas for visual aids throughout the plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Anerol C Who is Approving your Manufacturing Visual Aids / Process Sheets? Document Control Systems, Procedures, Forms and Templates 6
kedarg6500 How to Select Checking Aids APQP and PPAP 7
A Do Visual Aids Need to be Implemented? TL 9000 Gap Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Tim Folkerts Mnemonics & memory aids Coffee Break and Water Cooler Discussions 9
Marc Two-limbed tiptoe and Coconut aids octopus camouflage Coffee Break and Water Cooler Discussions 0
Gman2 How visible should visual aids be? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Submitting the Checking Aids on the PPAP's APQP and PPAP 5
M Procedures vs Training Aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Renault vs. AIAG FMEA - Would like details of it's usage and any training aids FMEA and Control Plans 4
J 4.5 Document Control and Shop Aids - Do shop aids need to be controlled? Document Control Systems, Procedures, Forms and Templates 3
D Are Eye drops made in China classified as medical device in China? ISO 13485:2016 - Medical Device Quality Management Systems 0
R Breast Pump under MDR classified as medical device? EU Medical Device Regulations 9
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K 820.200 Servicing Procedure - Our system (because there is an API involved) is classified as Class 3 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
E How is my medical device sofware classified under MDR? EU Medical Device Regulations 2
J Can subsidiaries use the holding company's ISO 9001 QMS and be classified as ISO 9001 certified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Is a 3V torch classified as medical electrical equipment needing EMI/EMC testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Does the cable assembly supporting a medical device gets classified accordingly? US Food and Drug Administration (FDA) 1
T Is a Removable Partial Denture classified as Class I Medical Device? EU Medical Device Regulations 6
I First Piece Inspection classified as a Key Process Input FMEA and Control Plans 2
T CFDA recently classified 23 products (9/27/13) China Medical Device Regulations 5
T 510k Submission - Class II Software communicates with a Non-Classified Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
L Laboratory Automation (classified as IVD in EU) Classification in China? China Medical Device Regulations 5
W Class I Medical Device classified as a Prescription Device? Other US Medical Device Regulations 2
somashekar Can a shaving razor blade be classified as a medical device Other Medical Device and Orthopedic Related Topics 5
R Are Traders classified as Suppliers in TS 16949? IATF 16949 - Automotive Quality Systems Standard 3

Similar threads

Top Bottom