Guest Post: The New Market Surveillance Regulation

The New Market Surveillance Regulation

Written by Roberth Jonsson, CEO of 24hour-AR

If you are selling products into the EU from outside the EU you may, or may not, have heard that there is a new regulation that came into force on 16th July 2021 called 2019/1020 or simply ‘The Market Surveillance Regulation’. It may come as an unpleasant surprise to find out that you may no longer be allowed to sell your products in the EU or the UK. This article will describe the regulation, explain when it is applicable and provide some guidance as to whether it affects you.

What is the new market surveillance regulation?

The 2019/1020 regulation has, amongst others, been developed to find a solution for the increasing number of ecommerce and other goods that enter the European Union without anyone taking responsibility and liability for the product. Every product sold after 16th July needs contact details for an EU economic operator so that market authorities can reach out and receive the technical documentation of a particular product if needed.

Are you affected by the new regulation?

My guess is that if you are an entity placed outside the EU and sell products to the EU you are affected in some way. There are four possible economic operators, which one are you?

1. The Manufacturer
   The manufacturer can, of course, have an entity or production facility in the EU. If this is the case, then all is good.
2. The Importer
   An importer is the second, and probably most common, type of economic operator. Many manufacturers use an importer as their EU economic operator. This means the importer needs full access to the technical documentation so that they can have a direct dialog with authorities if any questions arise. There are two major drawbacks to this:
   i. The manufacturer needs to provide all documents to the importer which can often contain essential business knowledge.
   ii. The importer needs to know and understand their responsibilities, such as checking the technical documentation, keeping the files for 10 years and cooperating with authorities if need be. Are you, the importer, prepared to pick up these tasks?
3. The Fulfilment Service Provider
   This could be considered the involuntary economic operator. One of the main things that the new regulation introduces is that when a product is provided through a fulfilment service provider and the product does not have an EU address, the fulfillment service provider automatically becomes the economic operator and needs to fulfill some legal obligations. Many fulfilment service providers are unaware that they are subject to fines if these obligations are not met.
4. The Authorized Representative
   This is not a new term but the definition and obligations have been clarified. The authorized representative (AR) is not recognized as a registered and certified company by the EU, but is rather an appointed representative chosen by the manufacturer to act on their behalf on all compliance related issues. The Swedish translation is quite clear in that it says the “manufacturer’s representative” which explains this better.

Do you also need an AR in the UK?

Yes, you are correct if you think that the regulation 2019/1020 does not apply to the UK. However, there is other legislation applicable to the UK that places the same requirements on products put to the UK market but now, of course, with a UK address. Every product sold in the UK needs a UK economic operator.

How should you act?

If you are placed outside of the EU, have not signed up an importer, are not using a fulfilment service provider or have not signed an AR, time is up, you need to act. To avoid sales stop, import troubles and even recalls and fines, find yourself one of the above operators and put the contact details onto the product. Don’t delay!

About the author

Roberth Jonsson is CEO of 24hour-AR, a company aiming to help companies sell their products legally on the EU and UK market by offering authorized representative services. 24hour-AR can also support with product compliance services and support in other related matters. Read more at www.24hour-ar.com