Regulatory Strategy for a Medical device of Risk Class IIa

[Thanga Bhuvanesh]

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]

Does the device limit the users able to use it? Is it made for specific users/patients?

 

[Thanga Bhuvanesh]

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]

Do these preferences or requests add any risk to the device?

 

[Thanga Bhuvanesh]

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]

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]

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.