Regulatory Strategy for a Medical device of Risk Class IIa

The medical device I work with is a Class IIa cardiopulmonary device according to EU MDR. This device has been in the market for 30 years and we are transitioning our Technical documentation from EU MDD to EU MDR. The device family is such that many different configurations of the device is available based on user requirements of each clinic. How can a approriate clinical evaluation strategy be created that covers this entire device family? has anyone encountered a similar situation before? Please advice. Thanks
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Does the device limit the users able to use it? Is it made for specific users/patients?
 
Basically the device fulfills the same purpose in each of the clinics we sell them. HOwever, each clinic requests a different configuration (for eg. length of tubing is longer, due to larger Operation room or differnt Heart lung machine). The configurations do not limit the users or have any limitations for the patients. These just prefernces of the clinics.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Do these preferences or requests add any risk to the device?
 
No they do not, each of these are handled as design changes. A risk analysis is performed for each of these changes and they are non-significant changes according to the definition of MDCG 2020-3.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Do you have a strong track record of use in the EU market you can rely on? Ultimately your NB will determine the needed path. Id suggest also reaching out to your salesperson at the NB for assistance and discuss options for clearance.
 

Ronen E

Problem Solver
Moderator
No they do not, each of these are handled as design changes. A risk analysis is performed for each of these changes and they are non-significant changes according to the definition of MDCG 2020-3.
In my opinion you can address all these versions as equivalent, i.e. evaluate them as a single model. Document a justification why the changes are non-significant from a clinical aspect - may be an appendix to the CER.
 

gabe2jadyn

Involved In Discussions
Hi! I don't know if this is where I need to ask this, but if not, please let me know where I need to go. When performing a new D4169 distribution simulation for a legacy sterile class IIa device, it seems the Confidence and Reliability rating of 95/90 which equals 30 samples is industry standard. Would an auditor who is a stats expert ever accept a C and R rating of 80/80 with a written a justification for the smaller size being we’ve been shipped X number of devices for X number of years, in all 4 seasons, with no complaints?
 
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