Risk Assessment for EU and UK Compliance
13 Nov 2023
Since 2016, manufacturers of products  declared compliant with ‘CE-marking’ EU Directives  have been legally required to include adequate risk assessments  in their Technical Documentations .
Remember: Creating a product’s Technical Documentation is a precondition for affixing the CE marking to it.
Also since 2016, Authorised Representatives, Importers, and Distributors have been legally required to cooperate with the relevant competent national authorities, as regards any risks posed by the products that pass through their hands.
There’ll be many compliance experts at EMC+CI 2024 at Newbury Racecourse on May 23-24 2024, so why not meet them there and discuss what to do for the best? www.emcandci.com
Here are some relevant links with regard to the risks of EMC compliance , but all of these EU Directives have the same/similar requirements.
See section 4.3 on Technical Documentation, on page 46, where it states (my underlining):
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the apparatus conformity to the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).” 
See page 28, where it says (my underlining):
I’ve used the word ‘product’ in this blog because it is used in the EU’s Blue Guide.
I’ve assumed that this concept can be extended to UK/NI markets because – before BREXIT – the UK laws requiring UKCA or UKNI marking were based upon the definitions in the Blue Guide and, at least at the time of my writing this blog, I am not aware that these definitions have been changed.
any EU Regulations that have replaced, or will soon replace, these Directives – including Medical Devices, Machinery Safety, etc.;
all UK Regulations equivalent to the above, with their UKCA and UKNI markings.
The word ‘adequate’ is not defined in the Blue Guide, but both https://www.merriam-webster.com/dictionary/adequate and https://dictionary.cambridge.org/dictionary/english/adequate say it means: “enough or satisfactory for a particular purpose”.
In this situation, the manufacturer and/or anyone in the supply chain could be said to have been at fault regarding the risk analysis and assessment in the product’s Technical Documentation .
The documents that are necessary for declaring compliance to the applicable CE-marking EU Directives , as specified in those Directives.
The EU’s EMC Directive EMC has nothing to do with safety – because it clearly states in its text (as it always has in previous versions) that it only applies to its Essential EMC Requirements, and that all safety issues are covered by other EU or UK/NI legislation, such as the LVD, Machinery, and Medical Device Directives.
EN 61000-3-3:2013+A2:2021, “EMC. Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current ≤ 16 A per phase and not subject to conditional connection”, includes two Annexes of the ‘ZZ’ type:
Annex ZZA covers the use of this standard when completing a risk analysis and assessment under 2014/30/EU, i.e. the EMC Directive, EMCD.
Annex ZZB covers its use when completing a risk analysis and assessment under 2014/53/EU, i.e. the Radio Equipment Directive, RED.
In fact, this is the main reason why the listing of harmonised standards in the OJEU is lagging so far behind the pace of the progress in the standards committees themselves (IEC, ISO, ETSI, etc.).
“Manufacturers may base their assessment on harmonised standards, which already include the risk analysis, but only as far as the risks are covered by that standard.” …actually means that manufacturers have the option of basing their risk analyses and assessments on harmonised standards that already include Annexes of type ZZ that cover the Essential Requirements of the Directive the manufacturer aims to declare compliance to.
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