The Importance Of Complying With The EU Market Surveillance Regulations

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From July this year, there are some important changes in the way the EU policies products that are entering it. Under the provisions of Regulation 2019/1020 which were brought into EU law in June 2019, manufacturers and suppliers of certain products now have to have an ‘Economic operator’ established within the EU.

This began because the authorities have had difficulty tracking down who is responsible for placing products on the market. This especially becomes an issue if there are safety or public health issues and they do not know who to contact. Until now, the companies responsible did not have to be within the EU borders. Especially so if any action results in cross country prosecutions. The EU is strengthening its activities ensuring only safe products are placed on the EU market.

Currently, all manufacturers irrespective of their location may appoint an ‘Authorised Representative’ within the EU to represent their interests but for most Directives and Regulations this was not a mandatory requirement. The one exception to this is for Medical Devices.

The role of an Authorised Representative is defined in the Blue Guide[1] and generally must have a written mandate from the manufacturer they represent detailing their level of authority and responsibility. This written mandate is most important. Normally the minimum responsibilities are:

  1. Keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities,
  2. Cooperate with them at their request,
  3. Provide that authority with all the information and documentation necessary to demonstrate the conformity of a product.

Of course, an Authorised Representative can have more responsibilities than these depending upon the products and the circumstances of the manufacturers. If they are also an importer or distributor, then they will have to fulfill those responsibilities.

What Does The New Regulation Mean?

Manufacturers must now carefully consider who represents them in the EU for product compliance matters. 

When a product enters any EU country it automatically has the right to free movement within the EU without any further checks taking place if correctly CE marked. Until July, the person responsible for placing the product on the EU market may not be well defined, especially with the many new routes to market which are opened up by new technology i.e. online sellers based anywhere with goods shipped from different locations.

The products that are within the legislation scope are shown in Annex I of the regulation and this covers some 70 pieces of EU legislation for which an Economic operator has to be established such as medical devices, PPE, toys and children’s products, clothes, footwear, and accessories. This regulation will apply to both e-commerce and physical marketplaces.

As a manufacturer, you should check your product Declarations of Conformity against this Annex and ensure that if your products are within the scope that appropriate action is taken.

Article 4 is where the requirement to appoint an Economic operator established in the Union with certain responsibilities originate. An Economic operator can be any of these parties. It is normally the manufacturer if they are established in the EU.

  1. A manufacturer established within the EU,
  2. An importer,
  3. An Authorised Representative who is acting under a written mandate from the manufacturer to carry out the tasks in Article 4.3 of the Regulation.
  4. A Fulfilment Service Provider established in the EU where no other economic operator for its products is established.

How Do The Authorities Know Who To Contact?

Article 4.4 states that the name, registered trade name or registered trade mark and contact details, including the postal address, of the economic operator shall be indicated on the product or on its packaging, the parcel or an accompanying document.

We interpret this as the information should ideally be on the product, packaging, and/or the user instructions for practicality. We do expect customs examinations to be looking for this information from July onwards so the more prominent and clear it is the better.

In terms of product information, Article 4.5 does limit the legislation to which it applies.

What Should Manufacturers Expect From An Economic Operator? 

As the Economic operator will be the first point of call for the authorities, they will need to ensure the information and documentation they hold is both timely and accurate. Expect to see the information scrutinized. This is especially true for compliance information such as Declarations of Conformity and also any test reports and information supporting the Declarations.

The market surveillance authorities have many powers under Article 14 from forcing economic operators to supply information, to unannounced on-site inspections and entry to premises, to enforce penalties, and for economic operators to take necessary action such as withdrawal of products or reworks, etc.

As well as this under Article 15 authorities may claim back all of their costs from their activities when noncompliance is established.

The costs could include these items:

  • Test costs,
  • Cost to taking measures for refusal to allow free circulation i.e. warehousing storage costs etc,
  • Costs for stock disposal and destroying,
  • Corrective action costs before releasing for free circulation.

These are all indirect costs that could be levied at the economic operator. There are also the associated costs of withdrawal, destroyed stock, a reworking of stock, recall/rework of units already in the market, and the costs of informing consumers of what is happening. There are also the indirect costs of this information being made public as a supplier may be requested to publicize any actions to be taken with a loss of reputation to the manufacturer.

That is why an economic operator will need to have confidence in the products and the documentation their name is associated with.

Next Steps For Compliance With The EU Market Surveillance Regulations

The bottom line is to make sure you are represented by good and trustworthy economic operators in the EU and you should not have any problems in compliance with the legislation. 

Contact Technology International to ensure compliance with help from experts in the field.