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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:
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Ronen E

Problem Solver
Staff member
Super 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
Super 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.
 
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