Powered wheelchairs (Class IIa) in the process of CE marking and use in hospitals

JoselVLC

Starting to get Involved
#1
Dear all,

In the framework of a European project, some doubts have appeared. Is it possible to use in hospitals some powered wheelchairs (medical device Class IIa) in the process to CE marking?. Some of the tests that are going to be performed at the hospitals are for providing the CE conformity assessment.

Thank you.
 
Last edited:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Dear all,

In the framework of a European project, some doubts have appeared. Is it possible to use in hospitals some powered wheelchairs (medical device Class IIa) in the process to CE marking?. Some of the tests that are going to be performed at the hospitals are for providing the CE conformity assessment.

Thank you.
Sounds like the clinical investigation route (MDD Annex X s. 2) would be appropriate. You can utilise that route until May 2020 (I think; didn't verify). If such use is expected past May 26, 2020, you'll need to look into the MDR's equivalent (more onerous generally).
 

JoselVLC

Starting to get Involved
#3
Sounds like the clinical investigation route (MDD Annex X s. 2) would be appropriate. You can utilise that route until May 2020 (I think; didn't verify). If such use is expected past May 26, 2020, you'll need to look into the MDR's equivalent (more onerous generally).
Thank you, Ronen. I have reviewed MDD Annex X s. 2 as you mentioned, but from this Annex, I do not understand if it is possible to use in hospital powered wheelchairs which have not CE conformity assessment yet in a controlled patients group. And assuming that these tests are for providing the CE conformity assessment.
Thank you.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thank you, Ronen. I have reviewed MDD Annex X s. 2 as you mentioned, but from this Annex, I do not understand if it is possible to use in hospital powered wheelchairs which have not CE conformity assessment yet in a controlled patients group. And assuming that these tests are for providing the CE conformity assessment.
Thank you.
This is exactly what Annex X s. 2 is for. You will have to comply with all its requirements to allow use under that scenario.
 
Thread starter Similar threads Forum Replies Date
R Maximum Reverse Speed Limit for Powered Wheelchairs Other US Medical Device Regulations 2
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 8
R ISO 10079-1:2014 on electric powered nasal aspirator Other US Medical Device Regulations 0
L DC Powered Medical Device Fuse / 15.4.3.5 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
T Battery Powered Device - MOP and Patient Auxiliary Currents IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J IEC 60601-1 Electrical Safety testing - Class 1 ME externally powered - Earth resistance testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E CB scheme applicability for battery powered medical devices CE Marking (Conformité Européene) / CB Scheme 0
F MOPP in battery powered device with metal enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
C Lithium battery powered Medical Device - 15.3.3 Impact test, broken enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
B Dielectric Test of Battery Powered Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N USB Powered EEG - USB provides 1 MOPP want 2 MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E Electrical safety (battery-powered medical device) EU Medical Device Regulations 1
E Testing ME equipment powered by Battery EU Medical Device Regulations 0
S IEC 60601 Main requirements for Lithium Ion Battery Powered Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Labelling Requirements for USB-Powered Device Other Medical Device Related Standards 1
M Battery Powered Measurement Equipment and Low Voltage Directive CE Marking (Conformité Européene) / CB Scheme 1
marmotte Classification for Nasal Aspirator (non powered) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
R Air-powered dental handpiece with LED IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K UL 6601 - Would an off-the-shelf Android tablet, powered by USB, pass UL 6601? Other Medical Device Related Standards 3
S Internally powered ME with non-conductive applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M IEC 60601 Charger requirement for Lithium Ion Battery Powered Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
R Isolation of Internally Powered (3.3 Vdc) ME Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C Battery Powered Beauty Products minimum Legal Certifications Requirements CE Marking (Conformité Européene) / CB Scheme 7
E Requirements for primary battery powered ME with BF-applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
X IEC60601 Battery powered devices intended for measuring bio-impedance IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W Is IEC 60601-1-2 compliance/testing required for battery powered Class I Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Single Fault Condition for Internally Powered Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Battery Powered Medical Device Battery Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
thisby_ Medical Device Battery Powered Equipment connected to Charger IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M IEC60601-1 Battery Powered Body Worn Device Leakage Currents IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R EU Regulations on powered wheelchair max speeds? EU Medical Device Regulations 7
Ronen E 510(k) Exemption: Powered Patient Transport / Wheelchair Elevator (Stairlifts) Other US Medical Device Regulations 0
R Does applied part of battery powered TENS unit need to be designed as type BF? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
C Creepage and Clearance for CR2032 powered fob for a Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
A Internally Powered Medical Device and Dielectric Strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
D Battery Powered Disposable Pump - What IEC 60601 testing is required, if any? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S Medical Device Battery Powered Equipment with Battery Charger Classification IEC 60601 - Medical Electrical Equipment Safety Standards Series 17
T Part 880.5100 AC-powered adjustable Hospital Bed - Applied Parts Marking or Labeling Other US Medical Device Regulations 1
D Means Of Protection of the Video OUT of an Internally powered device IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
L Data logging software for Palm powered PDA required Statistical Analysis Tools, Techniques and SPC 1
J Custom made medical devices - Wheelchairs EU Medical Device Regulations 6
M Servicing of Wheelchairs (wheel chairs) ISO 13485:2016 - Medical Device Quality Management Systems 4
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 2
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 4
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 0
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 2
A AQL - How to count samples with defects for each defect class AQL - Acceptable Quality Level 17
Similar threads


















































Top Bottom