< PreviousHowever, since those heady days immediately post- Brexit when a myriad of changes was announced, there has been a slow realisation that the changes are not so straightforward, with many original implementation timings having slipped. Implementing regulatory changes is no easy exercise for any business, but stopping or delaying these changes part way through can be equally challenging. For example, UKCA marking has a requirement to test, certify and print the mark on the product and/or packaging, requiring many months of preparatory work per product to get the correct details in place. This is done in time to meet an upcoming deadline. Since Brexit, this moved from a two-year to a three- year implementation period fairly early on, as many businesses stated that printing changes take a considerably long time to run through supply chains. However, a further extension to the implementation period was announced just two months before the extended deadline. This was confused by the fact that UKCA marking applies to so many regulations, and that onlytheso-called‘newapproach’regulationswerebound by the new extension. This has left many businesses and organisations in a halfway house of needing to 20 FOREVER DELAYED - UK REGULATORY CHANGES Anon bmta.co.ukbmta.co.uk At the time of Brexit, there was an expected shift in the regulatory requirements for the UK, with the government announcing procedures to replace those used under the EU system. Naturally, it was assumed that the implementation of these replacement procedures would come with a timeframe to allow businesses and industry to adjust to the new requirements. 21 bmta.co.uk comply by 1st January 2023 for some regulations, with adelayeddateforothers.Thishassincebeenclarified, meaning the extended extensions have been pretty much implemented across the board. Medical Devices, which have UKCA requirements, are on a different timeline again. An announcement in October 2022, stated that the reform of the Medical Device Regulations would be extended, that CE- marked products would be accepted for another 12 months from July 2023 to July 2024, and then moved into a transitional process whereby both UKCA and CEcertificatescanbeaccepteduntilaslateasJune 2028. While many businesses were still not ready, for those that had started to act it was as if the ship had already set sail and changes were going ahead regardless. These changes may have been the impetus to cease selling into the UK due to the increased cost of certificationandsupply.Othercompaniesmayhavehad dedicated business operations associated with UKCA marking,whichwillhaveseenasignificantdrop in demand. Unfortunately, this impact came late in the day due to the timing of the announcement to ease the deadline. Similarly,UKREACHstartedoutasa‘facsimile’ replacement of the EU chemical regulation REACH. Withindustryquestioningtheneedtohavethe‘same’ regulation as the EU but pay twice for both markets, the intent to adjust the UK REACH regime was announced by the government after the initial registration deadlines had been set. The subsequent deliberations of the regulatory regime for UK REACH have gone as far as extending the deadlines for registration by three years for all tonnage bands, with no indication of the actual registration requirements announced. The original and initial registration deadline for UK REACH was 27th October 2023. This has now been extended to 27th October2026.However,withthe announcement by the government in late November 2022, these dates still needtobeofficiallyamendedthrough Parliament, aiming to be on the statute bookspriortoOctober2023.Let’s hope for no political turmoil in the UK between now and then. Many in industry have the desire to see better transparency and openness around regulatory changes and implementation, but this is undermined by last-minute changes to deadlines. The two examples above probably have the greater cross-sector impact, but other regulations have also seen last-minute extensions announced for their implementation. These include the cosmetics regulation; UK responsible person details on packaging delayed from 1st Jan 2023 to 2025 (announced Sept 2022). The initial timeline was to allow two years for products to work through supply chains – three months does not tie in with a two-year process. The UK Biocidal Products Regulation had a deadline of 31st December 2022 to resubmit applications to the UK Agency where they had been previously submitted to the EU. Due to the high demand (foreseen or unforeseen), the legislation was changed in December 2022 to extend the processing and evaluation of applications to 31st December 2027. The General Product Safety Regulation, which has a requirement to include the producer/importer address for the UK – the implementation of which is to physically includetheaddress–hasbeenextendedbyfiveyears to the end of 2027. This was also announced just three months before the original deadline. In all these cases, it seems to show a lack of real understanding of the complexity of these regulations and how businesses manage them. These last- minute changes do not help businesses to plan how to implement the regulations in line with regulatory changes. Themantraof‘getBrexitdone’isaloteasiertosaythan actually tackling the complexities of some regulations. If only there had been more thought given to realistic timeframesattheoutset,maybewewouldn’tneedtobe sticking to the EU systems so much for so long.22 DON’T PAY LIP SERVICE TO YOUR TECHNICAL FILE Carl Hunt, Product Compliance Assessor, TÜV SÜD United Kingdom Conformity Assessment (UKCA) marking will be mandatory for most products placed on the market in Great Britain (GB) - England, Scotland, Wales, from 1st January 2023. This replaces the European Union’s (EU) requirements for CE marking due to ‘Brexit’. Overall, CE and UKCA marking is a four-stage process: 1.Conformityassessment-meetingthe‘essential requirements’,choosingstandards,andpossibly testing. 2.Documentation - this includes the creation of the DeclarationofConformity(DoC)andtechnicalfile. 3.Labelling - CE or UKCA marking and the manufacturer’sdetails. 4.Agreement of Economic Operator Responsibilities -theterm‘economicoperator’meanseitherthe manufacturer, importer, authorised representative, or distributor. TheaffixingoftheCEorUKCAmarkingtoaproduct indicates that the manufacturer has performed an adequate conformity assessment and that the product meetsthe‘essentialrequirements’ofagivenRegulation, such as the Electromagnetic Compatibility or Low Voltage (safety) Directives. This is supported by the DoC, which must be signed by a responsible person within the organisation. Most of this is already well-known but one aspect commonlyoverlookedisthetechnicalfile.Yetthisis arguably the most important element since it proves due diligence and evidence of compliance, should market surveillance authorities, such as Trading Standards, identify a problem with a product. In the UK, other examples of market surveillance authorities include the Health and Safety Executive (HSE) for machinery, pressure vessels, ATEX, etc; the Medicines and Healthcare products Regulatory Agency (MRHA);andtheOfficeofCommunications(Ofcom)for the protection and management of the radio spectrum. Itisimportanttonotethatduediligenceisdefinedwithin legal precedent. This means that you cannot simply take someoneelse’swordasevidence,andyoumustprove it as much as possible. One example would be receiving a photocopy DoC from a parts provider and nothing else. However,thiswouldprobablynotbesufficienttosupport the conformity assessment of the end product. What is a technical file? One of the most often asked questions of TÜV SÜD’sadvisoryservicesisregardingthecontents ofthetechnicalfile.Atechnicalfileisdocumented evidence to show that the product properly complies withthe‘essentialrequirements’oftheDirective(s)or Regulation(s) which apply to the product. AgoodstartingpointistheEU’s‘BlueGuide’onthe implementation of product rules which outlines the type of documents that surveillance authorities would expecttofindinatechnicalfile.Themanufacturermust establish the technical documentation that shows how the‘essentialrequirements’oftherelevantDirective(s)or Regulation(s) have been met. Agoodtechnicalfilemustcoverthedesign,manufacture and operation of products and could include: ● ISO / quality documents ● Physical construction / CAD drawings ●Risk assessment (if applicable) ● Test reports (if applicable) ● DoC ● Label exhibits ● Internal / external photos ●User manual ● Parts lists ● Block diagram ● Operational description ● Schematics bmta.co.uk23 bmta.co.uk Thetechnicalfileprovidesvitalevidencethatthecorrect procedures have been taken during product development and manufacturers must be prepared to show it to market surveillance authorities upon request. For CE marking, enforcement authorities are also entitled to demand the technicalfilebeprovidedinanyofficialEUlanguage,so be prepared to translate it. Thetechnicalfilecanbeatraditionalpaperfile,orstored electronically, with hyperlinks to documents. It must also be kept up to date as the product is adapted, which means that it cannot be put away and forgotten, and it must also be retained for ten years. ThosethatbringgoodsintoGBforthefirsttime (importers), have obligations to check the conformity assessment approach. This includes the DoC and technicalfile.However,itmaybethatthemanufacturer hassensitiveinformationwithinthetechnicalfilesthat they do not wish to share (typically the last four points listed above). This is perfectly acceptable, as the only party that must be provided with this information is the market surveillance authority. Likewise, anyone re-branding a product takes on the full responsibilities of the manufacturer. This includes signing the DoC, labelling with their details, and keeping the technicalfileonrecord. Trading Standards may also spot-check goods entering the UK, as importers are required to hold evidence of the testreportsandcertificatestoprovecomplianceinthe formofthetechnicalfile.Ifsuchinformationismissing, this may result in their prosecution as they have a legal responsibility for ensuring proof of compliance. Without it, the manufacturer, importer or retailer could face significantfinesorevenimprisonment. CONTRIBUTE TO OUR NEXT NEWSLETTER We encourage our readers to send in thought leadership articles and opinion pieces on a wide range of technical, operational and commercial issues impacting any aspect of the UK measurement and testing industry. Feature articles are usually between a half A4 page and two A4 pages of text in length. In addition to this, we would ask that you provide supporting images, at print ready resolution, together with a headshot and short biography of the author. If you would like to contribute, please email Laura Vallis at editor@bmta.co.uk24 UKCA MARKING AND MEDICAL DEVICES Itoro Udofia, Director, Medical Health Service, TÜV SÜD UKCA marking (UK Conformity Assessed marking) is the UK product marking requirement that is now required for any product being placed on the market in Great Britain (GB) - England, Scotland and Wales. This substitutes the European Union’s (EU) requirements for CE Marking and includes all medical devices. UKCA marking was specified in the original ‘EU Exit’ UK Statutory Instruments and indicates that a product placed on the market meets GB requirements. bmta.co.uk Formedicaldevices,theUK’sMedicinesandHealthcare products Regulatory Agency (MHRA) provides guidance on how medical devices are now being regulated. Medical devices being placed on the market in the UK must now follow the Medical Devices Regulations 2002 (SI 2002 No 618,asamended)(UKMDR).TheUKMDRincorporates the requirements according to EU legislation for ●Active implantable medical devices, Directive 90/385/ EEC (AIMDD) ● General medical devices, Directive 93/42/EEC (MDD) ● In vitro diagnostic medical devices, Directive 98/79/EC (IVDD) 25 bmta.co.uk Although the UKCA mark may be required to place medical devices on the market in GB, CE marked devices are also permitted. As of 1 July 2023, current rules state that it will be mandatory for every medical device to displaytheUKCAmarking.However,theUK’sMedicines and Healthcare products Regulatory Agency (MHRA) is proposing substantial changes. This includes transitional arrangements so that manufacturers can continue to place CE-marked medical devices on the GB market after 30 June 2023. Third-party involvement Where third-party conformity assessment is required, a UK Approved Body is needed. However, Class I devices and general IVD manufacturers can self-certify against the UKCA mark. It is important to note that the exception to the rule is Class I medical devices that are sterile or have a measuring function, as they require approval from aUKApprovedBodyinordertoaffixtheUKCAmarkand be placed on the GB market. If the manufacturer is located outside the UK, they must appoint a UK Responsible Person (UKRP), who must be based in the UK. The UKRP then acts on behalf of the outside-UK manufacturer to ensure that their obligations are carried out, and it is permitted for an importer or distributor to act as a UKRP. Their responsibilities include registering the medical devices with the MHRA before they can be placed on the UK market, and ensuring the manufacturer is compliant with the requirement and holds relevant documentation. It is important to note that the MHRA will only register devices where the manufacturer or their UKRP has a registered place of business in the UK. In all instances, where the UKCA mark has been affixed,thenameandaddressoftheUKRPmustbe included on product labelling. Market differences The Northern Ireland (NI) Protocol has created another layer of complexity for medical device manufacturers as it means that NI aligns with relevant EU rules relating to placing manufactured goods on the market. This means that in NI, the CE mark is still required, so even after 30 June 2023, CE-marked medical devices can continue to be placed on the market. Under these rules, qualifying goods are those in free circulation in NI - not those under a customs procedure or in an authorised temporary storage facility before being moved between NI and GB. If a UK body carries out a mandatory third-party conformity assessment, then a UKNI marking must be applied – but must be accompanied by EU conformity marking (eg CE marking). Goods with both the CE and UKNI marking cannot be placed on the rest of the EU market. If a mandatory third-party conformity assessment wascarriedoutbyanEU-recognisednotifiedbody, goods with the CE marking can be placed on NI and EU markets. As a deviation from the GB requirements, the Medical Device Regulations, 2017/745(EU MDR) and the In Vitro DiagnosticMedicalDeviceRegulations,2017/746(EU IVDR)applyinNIfrom26May2021and26May2022, respectively. This means that GB manufacturers will require an EU Authorised Representative, located either in NI or the EU, in order to place products in the NI market. The UK government guarantees NI businesses unfettered access to the UK market, without the need for additional approvals. Qualifying NI goods can therefore be placed on the GB market based on the conformity markings used in NI, such as the CE, and CE/UKNI markings. However, the UKCA mark cannot be used for goods placed on the NI market. To register with the MHRA you must show evidence that your medical device has undergone conformity assessment by a UK Approved Body, which must be based in the UK. Following approval from a UK Approved Body,themanufacturerwillbeabletoaffixtheUKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland). Alternatively, if your products are CE marked, thenyoumayalsouseyourCEcertificateasevidenceto register with MHRA until 30 June 2023.26 ENSURING MACHINERY SAFETY Darren Hugheston-Roberts, Head of Machinery Safety, TÜV SÜD For the UK market, the Supply of Machinery (Safety) Regulations 2008 continues to be in alignment with the EU’s Machinery Directive, but with slight amendments specific to BREXIT detailed within Schedule 12 of The Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019. The regulations apply to both machinery and safety components which are manufactured or sold and operated in the UK on or after 29th December 2009 and the UKCA requirements after 31 December 2022. BeforemachineryandotherproductsintheRegulations’ scope, are placed on the market or put into service for thefirsttimetheymustbedesignedandconstructedto besafe.Theymustalsohaveatechnicalfilecompiled and have appropriate conformity markings. Under the new regime, UKCA will be the marking applied under the regulation and CE will continue to be the marking applied under the Directive. Such equipment must also be supplied with comprehensive instructions, or assembly instructions in the case of partly-completed machinery, in English. They must also be accompanied by a Declaration of Conformity, or in the case of partly- completed machinery, a Declaration of Incorporation. The following persons or companies are responsible for compliance with the Supply of Machinery (Safety) Regulations: ● Machine builders ● Assemblers of machine parts or installations ● Manufacturers of special-purpose tools, skids and rigs ● Machinery importers located in the UK ●Machinery distributors or dealers that buy from a UK-based manufacturer or importer are obligated to verify that the conformity assessment was performed and that the necessary documentation and information is available. Relevant machinery under the regulations includes assemblies of machinery, components and interchangeable equipment: ● Anassemblyfittedwith,orintendedtobefittedwith a drive system other than directly applied manual or animal effort, consisting of linked parts or ● Components, at least one of which moves, and which arejoinedtogetherforaspecificapplication. ● Machinery referred to in 1 missing only the components to connect it on-site or to sources of energy and motion. ● Lifting apparatus whose only power source is directly applied manual effort. ● An assembly of machines and/or partly-completed machinery which, in order to achieve the same end are arranged and controlled to function as an integral whole. ● Interchangeable equipment - a device which, after placing into service with machinery or tractor, is assembled with that machinery or tractor by the operator himself in order to change its function. UKregulationsdefinearesponsiblepersonasonewho holdsapositionofsufficientresponsibilitytoensure machinery safety. However, they do not have to be an expert as they are allowed to seek appropriate advice. The responsible person must ensure that all the necessary research and tests are conducted so that machinery can be assembled and put into service safely. The responsible person must also ensure that the applicable Essential Health and Safety Requirements (EHSR)aresatisfied.Thesearewide-ranging,takinginto account potential dangers to operators and other persons who may be at risk. A typical example of an EHSR is the requirement to provide adequate warning labels where there are moving parts that might trap parts of the body of personnel using the machine. Another would be the requirement to provide safety guards for machine tools. The responsible person must also ensure that the technicalfileiscompiledandremainsavailablefor inspection by a competent national authority, such as the UK Health and Safety Executive, for a period of ten years bmta.co.uk27 bmta.co.uk after the last product was manufactured and placed on the market. However, it does not have to include detailed information such as the sub-assemblies of the machine, unlessknowledgeofthemisessentialforverificationand compliance with the EHSRs. The appropriate conformity assessment procedure must also be followed, these are dependent on the category of machinery and whether or not published designated standards are available, and if so, that they have been fully applied to cover all of the essential health and safety requirements of the machine: ● Regulation 10 – This regulation applies to machinery that does not fall within a category of machinery referred to in Part 4 of Schedule 2. In this case, the following conformity assessment procedure is applied: ● The responsible person shall follow the conformity assessment procedure with internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2 in respect of it. ● Regulation 11 – This regulation applies to machinery that falls within a category listed within Part 4 of Schedule 2 and that the machinery is manufactured fully in accordance with published designated standards, and that the published designated standards in accordance with which it is manufactured cover all the applicable essential health and safety requirements. In this case, one of the following conformity assessment procedures can be applied: ● the conformity assessment procedure with internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2; or ● the type-examination procedure prescribed in Part 9 of Schedule 2 and the internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2, point 3; or ● the full quality assurance procedure prescribed in Part 10 of Schedule 2. ● Regulation 12 – This regulation applies to machinery that falls within a category listed within Part 4 of Schedule 2 where the machinery is not manufactured fully in accordance with published designated standards; or, ● is only partly manufactured in accordance with the published designated standards which relate to it; or, ●the published designated standards in accordance with which the machinery is manufactured do not cover all the applicable essential health and safety requirements; or, ● no designated standards exist for the machinery. ●In this case, one of the following conformity assessment procedures can be applied, which in both instances require the intervention of an Approved Body: ● the type-examination procedure prescribed in Part 9 of Schedule 2 and the internal checks on the manufacture of machinery prescribed in Part 8 of Schedule 2, point 3; or ● the full quality assurance procedure prescribed in Part 10 of Schedule 2. The responsible person must also ensure that appropriate instructions are made available to operate machinery safely; that a declaration of conformity is drawn up; andthattheUKCAmarkingisaffixed.IntheUK,there was an extension to the acceptance of CE marking until 1st January 2023, after which the UKCA marking requirements are mandatory and a legal requirement. About TÜV SÜD www.tuvsud.com/uk TÜVSÜDisoneoftheworld’sleadingexpertsin producttestingandcertification,with150,000product certificatesincirculationglobally.ItsProductService division analyses over 20,000 products each year inEurope,Asia-PacificandtheAmericas,usingits technical expertise to help customers optimise market access. TÜVSÜD’sMachinerySafetyDivisionistheUK market leader in machinery safety, providing a range ofservicesonaworldwidebasis.Itisalsotheofficial partner of the Process and Packaging Machinery Association on regulatory affairs. TÜVSÜDBABTistheworld’sleadingradioand telecommunicationscertificationbodywithEU-based NotifiedBodiesandUKConformityAssessmentBody status. This enables TÜV SÜD to satisfy both CE and UKCA requirements for multiple EU Directives and UK Regulations, including those for radio equipment, machinery and electromagnetic compatibility, along with Wheel Mark and UK Conformity Mark requirements for marine equipment.28 TÜV SÜD’S NEW OCTAGON HUB REDUCES EMC AND RF TEST TIMES BY UP TO 75% Carl Wordsworth, Head of Water Sector, TÜV SÜD National Engineering Laboratory 28 The highly advanced automated test facility has significantlyincreasedTÜVSÜD’stestcapacityand delivered the capability to provide a 24-hour test service. All Radiated Emission chambers in the UK use EMX, TÜVSÜD’sbespokeradiatedemissionautomation software. This allows partial or full EMC testing automation and requires only minimal input from test engineers where a product can be controlled remotely. Theabilitytocontrolacustomer’sproductandcycleit through the different technologies during testing provides a faster and more repeatable service. TÜV SÜD can now customise its service to provide the mostefficientroutetomarketandcompletetestsmore quickly. This will help manufacturers achieve a shorter timetomarketandfulfillaunchtimescalesforproducts which integrate RF modules, including technologies such asBluetooth,WiFiandthenew6Efrequencybands. TÜV SÜD is seeing strong growth in the marketplace, particularly with module integrations. As industry increasingly adopts IoT and Industry 4.0 methods, a growing number of products are being developed to take advantage of wireless connectivity and this increased complexity necessitates more testing. OctagonHub’stestequipmentincludes: ●Twofive-metresemi-anechoicradiatedemissions chambers ● A three-metre semi-anechoic radiated emissions chamber ● Three EMX chamber automation systems - in combinationwithTÜVSÜD’sswitchingunitswhich allows fully automated testing with compatible products ● An AR Multi-Tone RF Radiated Immunity System 10kHz–6GHz–thisisfour-timesfasterforradiated immunity testing, compared to the industry standard, bmta.co.uk TÜV SÜD recently opened its Octagon Hub, a £2.88million state-of-the-art UK EMC and Radio Frequency test facility, measuring 22,000sq/ft. Based at TÜV SÜD’s Hampshire headquarters, the Octagon Hub’s three semi-anechoic EMC and RF chambers are in addition to five pre-existing ones. 29 bmta.co.uk traditional way of performing the testing. ● A Keysight 220GHz high-frequency measurement system–whichhasincreasedTÜVSÜD’shighest measurement range from 40GHz to 220GHz. As well as automating the test process, EMX also filestestresultsinreal-timesothattestreportscanbe automatically compiled. The automation of EMC test reports has become essential due to the complexity of today’sproductsandthesheervolumeofresultsthatare now taken during tests. An automated system such as EMX not only allows the entire process to be completed faster, it also reduces the human error factor when dealing with a massive volume of data. Radiated spurious emissions traditionally have quite a high level of measurement uncertainty. Much of this can be attributed to the requirement for setups and the positioning of measuring equipment to be changed by engineersduringtests.AsTÜVSÜD’snewEMCtest chambers are integrated with EMX, its bespoke radiated emissions test software, this creates a fully automated solution that minimises disturbance of the device under testonceithasbeenconfigured.Thehighlevelof automation within Octagon Hub is also enhanced by the newfive-metredualantennachambers,whichensure minimal or no physical interaction within the chamber as there are no antenna changes or setup changes required for switching between low to high-frequency ranges during tests. TheEMXswitchboxhasintegratedallfilters,attenuators and relays into one PC-controlled box that sets up the correct path for each test for the engineer. In the past, someofthefiltershadtobeconnectedmanually.This is now all fully automated. The EMX software drives the spectrum analyser, switching box, and chamber masts, alongsidethecustomer’ssample(wherepossible). This has created a “dark chamber” that is completely automated-afirstforTÜVSÜD. This means that measurements have a high level of repeatability and accuracy, helping to ensure that testing is completed on time and that lead times are minimised.Incaseswherethecustomer’sequipment canberemotelycommanded,thiswillofferthebenefitof increasing the amount of testing that can be completed with minimal disturbance. The new facility also offers the space and platform for further investments, which TÜV SÜD expects to be more than £8 million over the next few years. Phase two planning is already underway, with the following planned: ●Two 3m SAC Emissions Chambers ● ETS Lindgren AMS-8900 OTA Measurement System ● Two 5G NR FR1 Anritsu MT8000A ● Two 3G/4G Anritsu MT 8821C ●AR Multi-Tone RF Radiated Immunity System 80MHz –6GHz(TÜVSÜD’ssecondunit.Thefirstsystemis already available at the original Octagon House site) TÜV SÜD will become the only independent test lab in the UK to offer over-the-air (OTA) capabilities and one of a limited number of laboratories with 5G signalling units. During Phase 2, the addition of 5G Anritsu signalling units will also see TÜV SÜD enter the 5G module integration market. A new OTA chamber will also allow TÜV SÜD to perform antenna performance measurements in greater detail and at faster speeds. Measurements during tests will be able to better simulate real-world performance by encompassing hands or body parts that are in close proximity to the device antennas. This new capability will allow customers to better understand their antenna performance and tune their device to extend range and sensitivity, as well as increase battery life on portable units. Anewartificialintelligencecapabilityisalsobeing developed to verify the WLAN/BT test results generated by the automated systems and reduce the occurrences of human error. Phil Evans, Business Development Director for Connectivity at TÜV SÜD, says: “Octagon Hub represents the next generation of automation for testing and sample control, and is a real game-changer for high-end products integrating WLAN/BT with multiple antennas, such as VR/ AR headsets and routers. “Ournewfacilitieshavebeenspecificallydesignedto deliver automated mass testing that reduces test times significantly.Whatwouldtypicallytaketwo-to-threeweeks isnowdowntoaslittleasfour-to-fivedays.Thiswillallow manufacturers to minimise time-to-market for products that are bound by legal requirements, such as those mandated by the FCC in the USA, and for the European Union’sRadioEquipmentDirective. “Another new advantage is that our EMX software is designed to tune the output power for the customer to meet the output limit within regulatory standards across all frequency bands, modulations and bandwidths. This means it can cover every possible combination of output. As EMX does this automatically it saves a massive amountoftimeandallowscustomerstofine-tunemultiple times. This is particularly relevant if any hardware changes have been made, such as antenna changes.”Next >