Manufacturer in Norway: Authorised representative needed for EU?

[the_norwegian]

Hi,

We are a small start-up based in Norway, working to bring our first product to market in the EU/EEA. We will be the manufacturer of the product.

Since we are based in Norway (so, outside of EU, but inside the EEA) do we need an authorised representative based in the EU to put our product on the market in the EU?

Perhaps it goes without saying since this is the EU Medical Device Regulations subforum but the product will be regulated under MDR (class IIa)

 

[KShaw]

Hi,

We are a small start-up based in Norway, working to bring our first product to market in the EU/EEA. We will be the manufacturer of the product.

Since we are based in Norway (so, outside of EU, but inside the EEA) do we need an authorised representative based in the EU to put our product on the market in the EU?

Perhaps it goes without saying since this is the EU Medical Device Regulations subforum but the product will be regulated under MDR (class IIa)

Hi there!

No, you won't need an EU Authorised Representative in Norway since you're already in the EEA. I quote from MDCG 2022-16: "The ’Union market’ refers to the territories of the European Union Member States, and due to the European Economic Area (EEA) is extended to Norway, Lichtenstein and Iceland, and via the Customs Union Agreement to Turkey. For Turkey, please see also the ‘Notice to stakeholders EU-Turkey Customs Union Agreement in the field of medical devices’ on the Commission website." https://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf

 

[the_norwegian]

Thanks!