The New EU MD Regulations on Notified Bodies. Will They Affect Australian Manufacturers?

The New EU MD Regulations on Notified Bodies. Will They Affect Australian Manufacturers?

In September 2012, the European Commission announced a proposal for regulation changes to medical devices and in vitro diagnostic medical devices. According to Medtech Insight News these regulations are likely to be adopted by late 2016 or early 2017. Will these regulation changes impact the Australian Manufacturer? It depends.
The Australian Department of Health, Therapeutic Goods Administration (TGA) announced in 2014, “Commencing on 5 November 2014, Australian medical device manufacturers are able to use conformity assessment certification from European notified bodies when making applications to the TGA.” This was good news for Australian Manufacturers who manufactured or shipped overseas. Here are the criteria:

With this change, whether the medical device is manufactured in Australia or overseas the manufacturer can choose to have conformity assessment conducted by:

    • The TGA; or
    • An alternative conformity assessment body, such as a European notified body.

Be aware, not all the EU notified bodies (to date) will upgrade their actions and seek designation under the requirements of the future MD/IVD regulations. If you are using an EU notified body for your conformity assessment, you must ensure they will receive designation under the new MD/IVD regulations.

The European Association of Notified Bodies (TEAM-NB) has published a list of members’ intention to submit application to be designated against MDR and/or IVDR. There are 21 members listed. UK and Ireland account for five of the 21 organisations listed. To see the complete list click here.With the UK’s Brexit decision to leave the EU there is a lot of speculation regarding trade agreements. However, the listing of these four UK and one Ireland organisations (In the TEAM-NB intentions list) shows confidence that this decision will not impact regulatory agreements or trade.

Still Speculation
However, there is still speculation. What will the UK do? Two options have been suggested.

    • UK will join the European Economic Area through the European Free Trade Association (just like Norway).
    • Or that the UK may reach some mutual recognition agreement with the EU (as Switzerland has done).

Proposed Timelines
When the new EU MD/IVD regulations are adopted there will be a three to five-year transition period. If the regulations are adopted and published by early 2017, there will be a three-year transition period for medical devices. This gives medical device manufacturers until 2020 to comply. The IVD manufacturers have a five-year transition period giving them until 2022 to comply.

So what does this mean for Australian manufacturers? If you receive your conformity assessment through the TGA, these new EU MDR/IVDR will not affect you. If your conformity assessment is through the EU, make sure your notified body will receive designation for these new regulations by the proposed date.

For any regulatory enquiries contact KD&A on +61 4 11 101 392 or email us at