MRA EU-TGA Product Registration to EU Market

Nash27

Involved In Discussions
#1
We are planning to register medical devices to European market Under the MRA (Mutual Recognition Agreement- TGA Australia and EU). Could you someone give a brief description on critical components that we need to ensure compliance with EU MDD requirements. Our initial pathway shall be as below;

• Selection of an EU representative
• Amending the post market surveillance and other relevant OP’s to meet the EU MDD requirement covering adverse event report notification, product advisory notices and product recalls.
• Compliance with Essential Requirements
• Amendment of label and IFU’s to meet the EU MDD requirements.
• Internal Training associated with changes / new requirements

Beside this are there any critical points that we need to worry about. Any suggestions would be really helpful. Thanks
 
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Nash27

Involved In Discussions
#2
Just giving a feedback on my above post. The pathway described above is a standard procedure for the Australian manufactures who would like to take advantage of MRA (mutual recognition agreement). One thing I would like to add above, the manufacturer need to demonstrate that substantial product realisation activities are carried out in Australia or New Zealand. How you demonstrate is up to the manufacturer.

If you have any further queries on this post I am happy to assist.:thanx:
 
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