MSQ Engineer
Registered
Our company designs/manufactures medical devices which are components of an overall "system", and then we purchase and re-sell the other components of the overall system (both packaged with and separately from our component devices). For Example:
Now, our NB has come back from their initial technical documentation review and is asking us to clarify what exactly our UDI covers, if Article 22 applies, how we define our accessories, etc. Between the regulatory terminology, our internal terminology, and the MDR in general, I've confused myself in circles now too....
1) I use "system" in the general system engineering sense in our documentation. I know Art 22 shouldn't apply in our case since a Declaration of Conformity and GSPR 14 ensure interoperability. But, does our 'system' meet the definition of an MDR system? The MDR defines a system based on combination "for a specific medical purpose". I take that to mean a (more) specific medical purpose consistent with (but narrower than) the overall intended purpose. Am I just confusing the NB by using the word system?
2) Do we need a separate UDI-DI for the software and the hardware, or can we say one UDI-DI covers both? We sometimes sell each separately.
3) For the measurement probes, I assume we would not want to package / relabel and just ensure that we sell CE-marked medical devices. In this case, are we acting as a Distributor or Importer? The whole placing on market, etc terminology confuses me. Would we need to worry about post-market surveillance, risk management, etc for them?
4) What happens if we want to sell non-CE-marked probes? We would have to act as manufacturer, but could we consider those as part of the hardware UDI-DI? Or, would we have to assign separate UDIs and make separate Declarations of Conformity? Does it matter if they are manufactured as medical devices or not? In this case, I assume we would be responsible for PMS, risk management, and all that, correct?
5) In our catalog and documentation, we call everything besides the hardware and software an "accessory" and we maintain a list of "approved accessories". PC and cables would be 'accessories for medical devices' under the MDR. Would non-essential accessories like cases be accessories or just non-medical devices? Can we classify the measurement probes as accessories for (our) medical devices, even if they are medical devices themselves?
6) What exactly are we doing with each component, economic operator-wise? We definitely are manufacturer for the hardware and software. When we supply a laptop, are we a manufacturer or importer/distributor? When we include measurement probes with our devices or sell them separately (we do not relabel or identify them as ours), would we be an importer or distributor?
Can anyone help me understand better?
- Laptop PC - Supplied by user, although sometimes supplied by us
- Software - Class IIa - Designed/Manufactured by us
- Hardware Modules - Class IIa - Designed by us, produced by subcontractor
- Measurement Probes - Class I - Procured from vendor (may be manufactured as non-medical device, non-CE medical device, or CE-marked medical device)
- Misc Peripherals - E.g., USB cables, power cables, travel cases, etc
Now, our NB has come back from their initial technical documentation review and is asking us to clarify what exactly our UDI covers, if Article 22 applies, how we define our accessories, etc. Between the regulatory terminology, our internal terminology, and the MDR in general, I've confused myself in circles now too....
1) I use "system" in the general system engineering sense in our documentation. I know Art 22 shouldn't apply in our case since a Declaration of Conformity and GSPR 14 ensure interoperability. But, does our 'system' meet the definition of an MDR system? The MDR defines a system based on combination "for a specific medical purpose". I take that to mean a (more) specific medical purpose consistent with (but narrower than) the overall intended purpose. Am I just confusing the NB by using the word system?
2) Do we need a separate UDI-DI for the software and the hardware, or can we say one UDI-DI covers both? We sometimes sell each separately.
3) For the measurement probes, I assume we would not want to package / relabel and just ensure that we sell CE-marked medical devices. In this case, are we acting as a Distributor or Importer? The whole placing on market, etc terminology confuses me. Would we need to worry about post-market surveillance, risk management, etc for them?
4) What happens if we want to sell non-CE-marked probes? We would have to act as manufacturer, but could we consider those as part of the hardware UDI-DI? Or, would we have to assign separate UDIs and make separate Declarations of Conformity? Does it matter if they are manufactured as medical devices or not? In this case, I assume we would be responsible for PMS, risk management, and all that, correct?
5) In our catalog and documentation, we call everything besides the hardware and software an "accessory" and we maintain a list of "approved accessories". PC and cables would be 'accessories for medical devices' under the MDR. Would non-essential accessories like cases be accessories or just non-medical devices? Can we classify the measurement probes as accessories for (our) medical devices, even if they are medical devices themselves?
6) What exactly are we doing with each component, economic operator-wise? We definitely are manufacturer for the hardware and software. When we supply a laptop, are we a manufacturer or importer/distributor? When we include measurement probes with our devices or sell them separately (we do not relabel or identify them as ours), would we be an importer or distributor?
Can anyone help me understand better?
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