Regulatory Compliance

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The Impact of Brexit

Now the UK has left the EU, UK manufacturers exporting products requiring CE marking to the EU are required to have appropriate representation in the EU, with similar obligations for EU manufacturers exporting to the UK.

For exporters who ship goods direct to their foreign customers, or importers who purchase, sell and distribute imported goods without the desire and/or ability to get involved in regulatory compliance, we provide an Authorised Representative service: a simple and convenient solution where we assume the responsibility to provide assurance that relevant imported goods are compliant with applicable regulationsFrom 16 July 2021, the EU Market Surveillance Regulation (Regulation 2019/1020) comes into force to implement increased market surveillance with the goal of ensuring compliance with these regulations in the EU marketplace.

The Specifics

When the Brexit transition period ended on 31 December 2020, the EU and UK diverged on the issue of product safety legislation. Whilst the UK has implemented the UKCA mark, it will recognise the CE mark as evidence of a compliant product until 31 December 2021. From 1 January 2022, only the UKCA mark will be recognised as evidence of product conformity with UK regulatory requirements (there are some specific exceptions to this). In the EU, however, the CE mark is, and will continue to be, the only evidence of product conformity with the relevant requirements of the applicable EU directive(s). The situation is more complex in Northern Ireland (NI), but to all intents and purposes any product manufactured in either the EU or GB and imported into NI, must be CE marked. Any such product manufactured in NI must be similarly CE marked. Whilst the requirements until 31 December 2021 are clear, there is the potential for further change from 1 January 2022. 

Types of Conformity

Products requiring CE or UKCA marking, effectively fall into one of two camps: those requiring verification of conformity by an accredited Notified Body (EU) or Approved Body (UK), and those that are verified as conforming by a process of self-certification (Self Certified). Only EU accredited Notified Bodies can verify product CE conformity, and only UK accredited Approved Bodies can verify product UKCA conformity. Self-certification is, as the name suggests, verification of conformity by the manufacturer. 

Manufacturer's Representation

Both the EU and UK require that manufacturers introducing appropriately certified products into their respective jurisdiction, must have appropriate representation resident in that jurisdiction. When the UK finally left the EU on 31 December 2020, a UK based manufacturer was no longer based in the EU, and vice versa. Some larger manufacturers have met this obligation for representation by establishing subsidiaries in the relevant jurisdiction.   For other manufacturers, predominantly SME's, this is not a commercially viable option.

Exporting to the EU

From 16 July 2021, the EU will introduce Regulation (EU) 2019/1020, to enhance market surveillance and provide greater assurance of compliance with applicable EU directives and regulations. It does this by clarifying the role and obligations of the Economic OperatorThe Economic Operator will be required to provide the relevant Market Surveillance Authorities (MSA) with evidence of regulatory compliance on request. The Economic Operator can be the manufacturer, an importer, a Fulfilment Service Provider (FSP), or an Authorised Representative (AR); whichever it is, the Economic Operator must be resident in the EU. We meet the obligations of the Economic Operator by fulfiling the role of either your FSP and/or AR .

Exporting to the UK

The UK regulations state  that the responsibility for ensuring the conformity of goods entering the GB market (not the UK market given that Northern Ireland is effectively part of the Customs Union) lies with the EU (non-UK) based manufacturer, and either the UK based Importer (if one exists) or the Authorised Representative appointed by the manufacturer. Regardless of whether the responsibility for representing the manufacturer is assigned to an importer or an AR, the obligations are the same, i.e. to provide assurance that the goods conform with the relevant requirements, and to cooperate with relevant UK authorities.

Conformity Assurance 

Regardless of whether or not the applicable Directive requires the involvement of a NOBO, the Economic Operator is obliged to be appropriately assured of conformity with the applicable requirements. This assurance of conformity is provided by way of periodic verification of product manufacturing processes; the type, frequency and scope of such planned verification being dependent on the risk inherent to the product. In essence, this verification confirms the effectiveness of the manufacturer's Quality system, thereby providing assurance of consistently conforming product.