Device2020
Registered
I have a situation where I'm trying to get some clarification from the Regulatory Network and see if anyone else has experienced the same situation.
Our medical device is a System, and is currently, CE marked under MDD.
We are moving to MDR as we have a new product that requires MDR, so thought we'd do both at the same time.
The System is a medical device consisting of three parts. Without either of the parts, the device does not function.
The System is classified as Class IIb to meet the intended purpose.
There is an EMDN code for the System.
At the time of the patient starting on the system, it can not be determined how long a patient will require this therapy. Two of the parts contained in the system are also supplied on a monthly basis to the patients as a refill (as these two components have to be changed throughout the month and monthly) until they have finished therapy.
We understand that because of this, the two components (which are supplied as a Refill Pack), will be classed as accessories and will have to be risk classified separately from the device in which they are used.
These parts/accessories will hold the same EMDN code as the system. As they cannot be used standalone or with any other medical device.
The components have been designed, developed, and validated as a System and as such we have 1 Technical File, which would be Conformity Assessed as one medical device (all components).
Our Notified Body, is saying that we need to have a separate conformity assessment for these parts/accessories.
We understand that accessories are required to be conformity assessed. However, what we don’t understand, is why there would be a separate conformity assessment on these parts, if they are already being conformity assessed as part of the System (includes all components/accessories) conformity assessment.
We are asking them why they would be conformity assessing a technical file twice.
Thanks in advance for your view on this situation.
Our medical device is a System, and is currently, CE marked under MDD.
We are moving to MDR as we have a new product that requires MDR, so thought we'd do both at the same time.
The System is a medical device consisting of three parts. Without either of the parts, the device does not function.
The System is classified as Class IIb to meet the intended purpose.
There is an EMDN code for the System.
At the time of the patient starting on the system, it can not be determined how long a patient will require this therapy. Two of the parts contained in the system are also supplied on a monthly basis to the patients as a refill (as these two components have to be changed throughout the month and monthly) until they have finished therapy.
We understand that because of this, the two components (which are supplied as a Refill Pack), will be classed as accessories and will have to be risk classified separately from the device in which they are used.
These parts/accessories will hold the same EMDN code as the system. As they cannot be used standalone or with any other medical device.
The components have been designed, developed, and validated as a System and as such we have 1 Technical File, which would be Conformity Assessed as one medical device (all components).
Our Notified Body, is saying that we need to have a separate conformity assessment for these parts/accessories.
We understand that accessories are required to be conformity assessed. However, what we don’t understand, is why there would be a separate conformity assessment on these parts, if they are already being conformity assessed as part of the System (includes all components/accessories) conformity assessment.
We are asking them why they would be conformity assessing a technical file twice.
Thanks in advance for your view on this situation.