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Radio-enabled machinery faces new regulation

Radio-enabled machinery faces new regulation

What does the replacement of the Radio and Telecommunications Terminal Equipment Directive by the new Radio Equipment Directive mean for machine builders? Paul Taylor of TUV SUD explains.

Even before we reach the golden goal of Industry 4.0, machines are increasingly incorporating radio-based components which rely on the radio spectrum to operate. Examples include systems for the wireless connection of safety devices, such as

E-stops, or in the operation of metal detectors. As increasingly complex and convergent technologies are introduced and we head towards Industry 4.0-based production methods, so the compliance process can appear increasingly intricate and unpredictable.

Now, the entire machinery supply chain (manufacturers, importers and integrators of radio equipment) has the European Union’s new Radio Equipment Directive 2014/53/EU (RED) to deal with. As of 13th June 2017, the RED completely replaced the old Radio and Telecommunications Terminal Equipment Directive (R&TTE). Changes between the two frameworks have a significant bearing on how manufacturers gain CE Marking. It’s therefore crucial to fully understand these regulatory differences in order to avoid time and cost overruns.

The RED’s new requirements are intended to clearly spell out the responsibilities and obligations for every economic operator involved in the supply chain (manufacturer, importer, distributor, authorised representative). The Directive is applicable to all electrical and electronic devices that intentionally emit and receive radio waves at frequencies below 3,000GHz. This is also the first time that equipment operating below 9kHz requires radio testing as the RED scope is for products operating below 3,000GHz, whereas the R&TTE scope started at 9kHz. For the first time, broadcast radio and TV receivers fall within its scope.

The following definition explains what products are subject to the RED: “Radio equipment – an electrical or electronic product which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory (such as an antenna) so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination.”

The introduction of the RED means if machinery manufacturers want to carry on selling within the EU and European Free Trade Association countries, they must test and if required re-certify to the Radio Equipment Directive, otherwise they can no longer be placed on the market. Consequently, many manufacturers are finding achieving compliance to be a significant challenge as they have never before been required to undertake RF testing.

To enable full traceability, every economic operator within the supply chain must identify who has supplied them and to whom they have supplied radio equipment. The product must also be accompanied by instructions, and manufacturer’s contact details, in a language which can be easily understood within the Member State in which it is being sold.

One key change, which is causing confusion amongst manufacturers is that the conformity assessment process now requires them to undertake a risk analysis and assessment. Many manufacturers are struggling to fully understand these changes, as there is no explicit description of the risk assessment process within the RED; it is instead referenced in the EU’s New Legislative Framework. While manufacturers have experienced approvals managers, they are not familiar with a risk assessment approach and may not have the skill set to deal with this new requirement.

Under the RED, importers also have new responsibilities as, when appropriate, they must now carry out sample testing, investigate and maintain a register of complaints and product recalls, as well as keep distributors informed of this monitoring process. For up to ten years after the equipment has been placed on the market, surveillance authorities have a right to request a copy of the Declaration of Conformity (DoC), and it is the importer’s responsibility to ensure that this is available.

The RED has also changed who is responsible for re-branded equipment within the supply chain. Importers and distributors take on the responsibilities, which were once those of the original manufacturer, where radio equipment is re-badged and supplied under their own name or trade mark.

As increasingly complex and convergent technologies are introduced and we head towards Industry 4.0-based production methods, so the machinery safety compliance process can appear evermore intricate and unpredictable. The RED’s wide ranging changes are requiring some significant adaptations to how radio-enabled machinery is manufactured and supplied, and it is having a significant impact on the manufacturing supply chain, each part of which must prove compliance with their specific obligations.

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