Medical devices reforms: Mutual Recognition Agreements

Project overview

Australia and the United Kingdom (UK) have a Mutual Recognition Agreement (MRA)- external site that replaced the EU-Australian agreement following Brexit.

It provides for the mutual acceptance of Conformity Assessment for medical devices.

This agreement provides for the UK to recognise Therapeutic Goods Administration (TGA) certificates issued to Australian manufacturers under the UK Medical Device Regulations 2002. See UK-Australia Mutual Recognition Agreement.

The part of the agreement that provides for the TGA to recognise certificates issued by a UK Market Conformity Assessment Body (UKMCAB) is not yet operational.

MRAs with the European Community and the European Free Trade Association

The European medical device directives have been replaced by the new Medical Device Regulation (Regulation (EU) 2017/745- external site). 

As a result, the previous European - Australian MRAs have been superseded and are no longer operational. 

We worked with all Australian manufacturers that used TGA EU MRA certificates to manage this transition.

Details for how Australian manufacturers can use the UK-MRA to gain access to the UK market

Australian manufacturers who hold a TGA Conformity Assessment (CA) certificate are eligible to apply for a UK CA certificate under the MRA. 

However, it is important to note that Class III and IVD medical devices are not covered by the agreement. 

Manufacturers have the option to apply for both UK CA and TGA CA certificates simultaneously through a single submission process. 

The combined application process attracts a fee of $1460. 

The additional assessment required for UK CA certification is largely administrative in nature, given the regulatory requirements between the two jurisdictions are closely aligned. 

To cover the administrative work involved in issuing a UK CA certificate (including drafting contracts and preparing documents) an additional UK CA fee of $1982.20 is applied. 

Once certified, the TGA will conduct an annual surveillance audit that encompasses both the TGA CA and UK CA certifications. 

The audit will be charged at the TGA’s standard surveillance audit rate.