TGA CER & EU MDR CER Requirements for Australia

[jbm12]

Hello Everyone, I wanted to ask if a company is launching a new product into the European and Australian market if the company is already creating a EU MDR Compliant CER for implants and instruments would a TGA CER still be needed for TGA submission. I was reading on the TGA Website they are accepting documents which were submitted to EU by the manufacturer so was thinking would TGA accept a EU MDR? Avoid the hassle of creating a TGA CER?

 

[lahol]

MDR compliant CER should be more than sufficient for TGA's requirements

 

[debbie gallagher]

I agree, EU MDR would be sufficient, but you would need to document compliance with Australian Essential Principles as well as the EU MDR General Safety and Performance Requirements?

 

[jbm12]

Thank you for the replies also another question I had was what if we are choosing a MDSAP pathway to get into the AU market can we still use a EU MDR CER? Also for EP 14 wouldn’t the EU MDR CER satisfy this EP and many others?