Development difference of CMDR and EU IVD Directive

[Szaki87]

Dear All!

I hope someone can help me. I'm just trying to figure out what is the difference between the EU IVD directive and EN ISO 13485:2012 required development efforts, procedure and the Helath Canada required development process description.

Or the EN ISO 13485 and the CMDR regulations are broadly similar?

Sorry I am new in the Canadian registration process. I know that there are Canadian ISO 13485 (CAN/CSA ISO 13485:2003) for example. But there is any document, or regulation what can be compared with the EU legible and effective standards, directive?

Thanks,
Attila

 

[DannyK]

Dear All!

I hope someone can help me. I'm just trying to figure out what is the difference between the EU IVD directive and EN ISO 13485:2012 required development efforts, procedure and the Helath Canada required development process description.

Or the EN ISO 13485 and the CMDR regulations are broadly similar?

Sorry I am new in the Canadian registration process. I know that there are Canadian ISO 13485 (CAN/CSA ISO 13485:2003) for example. But there is any document, or regulation what can be compared with the EU legible and effective standards, directive?

Thanks,
Attila

The first step is to correctly classify the IVD based on Health Canada classification requirements. If it is class II there are not very many documents that have to be submitted with the application. However for class III IVDs, you have to provide documents that prove that the device is safe and effective. The format that needs to be submitted is in the license application form for class III. There are several guidance documents that could be referred to, as well.

 

[Szaki87]

Dear DannyK!

Thanks for your reply. I think that this device will be class II device because of this is a diagnostic device for measuring and analyzing human blood samples (no direct contact to the human body) - so we can classify the device as a class II device (it is classified in the U.S. market also class 2). Our company has a quality department also but my task will be the development compliance verification. We have also FDA approval. May it helps to give me instructions.

So the core question is if we have a class II device then the development how conforms to the SOR/98-282 requirements, etc. in relation with the CMDR.

Thank you for your further comments.

Attila

 

[DannyK]

Go to mdall.ca and do a search on the medical device and you will be able to confiirm the classification.
Do not forget that your system has to be audited by an approved CMDCAS certification body.
If you need more detailed info, please feel free to send me a private message.

Good luck