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 York EMC Services CE Marking to European Directives

The impending exit of the UK from the European Union shakes many foundations. In our world, the acceptance of products through the CE Marking process affects billions of dollars of trade in electronics, medical devices, construction materials and a myriad of others.

American Certification Body’s Pieter Robben, Senior Reviewer, provides some context and understanding about the options and realities facing this complex and entangled shift in trade protocols. Pieter is based in the Netherlands and keeps a keen eye on regulatory shifts in the wind.

One important sector that permeates our lives is wireless devices. For ACB, it is our daily bread and we are fortunate to see the advances in connected technology that improve our safety, health, entertainment spaces and critical infrastructure for a wireless world.

Here, Pieter offers some perspective on the change in regulations.

Timeline for Brexit?

The UK will definitely be leaving the EU on January 1st 2021 and from that date onwards the UK regulations relating to EMC and radio equipment will come into effect as well as the regulation which introduces the United Kingdom Conformity Assessment (UKCA) mark. For the moment, nothing will change in terms of requirements and essential technical assessment. Both regulations are currently adoptions of the “EU EMC Directive” and the EU “Radio Equipment Directive” (EMCD & RED) which drive the assessments for electronic equipment of all types.

Currently, it is indeed presumed that the standards which need to be used for the UKCA mark are the same standards as currently in use for the EMCD/RED, except that the name of the standard will be preceded by “BS” (British Standard, each member nation of the EU has a nationalized version of the common standard). As far we know there is no list available yet of the “BS” standards which will be linked to the UK EMC and radio equipment regulations.

Transitions & Important Dates: There is a transition period of one year where the CE marking will still be accepted by the UK government. The earliest date where the UKCA mark will become mandatory and where the CE mark loses its legal meaning in the UK will be January 1st, 2022. However, ACB will be designated as a Notified Body for the UKCA mark (or actually, the UK regulations for EMC and radio equipment) as per January 1st, 2021. In case there is a commercial demand for affixing the UKCA mark per January 1st, 2021 ACB can be of service. That is, assuming that a list of “BS” standards will be published before January 1st, 2021 by the British government. We watch this continually and will provide updates when the situation changes.

Note that manufacturers can only obtain a certificate relating to the UKCA mark from designated “Notified Bodies” (ACB is one) for the UK regulations. Currently, there is no agreement between the UK and the EU, however, it is expected that no EU Notified Bodies will be designated as a Notified Body for the UK regulations in the foreseeable future.

Representative in the EU? There is a lot of confusion about the need of a “representative” in the UK. This confusion arises from the following: currently when a company outside of the EU exports products to the EU and the importer is located in one or more EU member states (excluding the UK) then the receiving entities of products which are shipped to the UK by the importer are “distributors.” In the context of the EMCD/RED a distributor has not as much obligations as an importer. However, per January 1st, 2021 the entities in the UK which now function as distributors will automatically become importers. This is explained in the regulations we referred to. This is an important nuance because the responsibilities magnify if a manufacturer has a distributor and not just a representative. For now, if a manufacturer now exports products directly to the UK then nothing changes.

A second source of confusion is the so-called “authorized representative.” In the context of the RED there is a possibility for a manufacturer to appoint an authorized representative in the EU which takes care of certain activities as specified in a written mandate (see Article 11 in the RED and Annex II, point 5 and/or Annex III, point 4). This is the same in the UK regulations. Please note that it is not mandatory to appoint such an authorized representative. If you have designated an authorized representative in the EU (excluding the UK) before the UK leaves the EU then nothing changes, such authorized representatives will still be recognized by the UK government. If you designate an authorized representative after the UK has left the EU then the authorized representative (in the context of the UKCA mark and UK regulations) will need to be located in the UK. But again, it is not mandatory to appoint an authorized representative, if you currently do not have an authorized representative in place then nothing changes.

For questions or additional information, contact ACB.