Hello,
I have a question concerning article 22(4) related to Systems/Procedure packs.
When it says that ".. incorporates devices that do not bear a CE-mark..". Does the "CE-mark" refer to the MDR medical CE-mark or also the CE-mark from other legislations as mentioned in article 22(1)(c)? For instance if we use an off-the-shelf camera in our procedure pack, do we fall under article 22(4)?
So to summarise, if we have a Procedure pack (PP) composed of :
- A MDSW, class IIa according to rule II of MDR, developed by "us, the manufacturer" : (let's call it "MDSW A")
- An Off-the-shelf electrical hardware, certified in its legislation (let's call it "HW B")
We are planning to certify the MDSW A, as a medical device software following rule II of MDR (class IIa).
However as the PP also contains HW B, which does not have a medical CE-mark, should PP be considered as a medical device on its own and also need to be subject to the relevant conformity assessment procedure pursuant to Article 52 ?
Therefore, would we need to certify under MDR both :
- The MDSW A on its own and;
- The PP ?
I hope I am clear and I really hope I can have some help on this !
Thank you very much!
I have a question concerning article 22(4) related to Systems/Procedure packs.
When it says that ".. incorporates devices that do not bear a CE-mark..". Does the "CE-mark" refer to the MDR medical CE-mark or also the CE-mark from other legislations as mentioned in article 22(1)(c)? For instance if we use an off-the-shelf camera in our procedure pack, do we fall under article 22(4)?
So to summarise, if we have a Procedure pack (PP) composed of :
- A MDSW, class IIa according to rule II of MDR, developed by "us, the manufacturer" : (let's call it "MDSW A")
- An Off-the-shelf electrical hardware, certified in its legislation (let's call it "HW B")
We are planning to certify the MDSW A, as a medical device software following rule II of MDR (class IIa).
However as the PP also contains HW B, which does not have a medical CE-mark, should PP be considered as a medical device on its own and also need to be subject to the relevant conformity assessment procedure pursuant to Article 52 ?
Therefore, would we need to certify under MDR both :
- The MDSW A on its own and;
- The PP ?
I hope I am clear and I really hope I can have some help on this !
Thank you very much!
