Conformance Limited

At Conformance we often have customers who have purchased machines from China with a “CE” mark on the label. We are asked to look at them and give an opinion on the safety. When Importing machines from China, end users have the following options:  · Assume all is OK as there is a CE mark on the machine and put the machine into service. This can be risky as any incident and subsequent investigation by the HSE is likely to lead to prosecution. · Perform due diligence and review the safety either internally or by employing a third party. If the machine is found to be safe then it can be put into service, however if the machine is found to be unsafe then the situation becomes more complicated. The first option would be to request that the manufacturer makes modifications to make the machine safe. This option may not be possible due to logistics. The second option is for the end user to make modifications but this throws up a further dilemma; if the modifications are significant then it could be argued that it is a new machine and the end user will therefore take responsibility for the CE Marking of the machine. Alternatively, an assessment against the requirements of the Provision and Use of Work Equipment Regulations (PUWER) will ensure that the machine is safe to use and if the assessment is done correctly it should ensure that an incident does not take place. While taking this route may ensure that the machine is safe to use, it does not take away legal obligations as previously discussed. #CEMarking #ProductCompliance #Machinery #MachinerySafety #PUWER #Manufacturing https://lnkd.in/eysEQZg7

❓ Do you have an Authorised Representative? If your business is based outside the EU or UK, you may be required to appoint an Authorised Representative to ensure your products can be legally placed on the market and to provide a clear point of contact for Market Surveillance Authorities. Without the correct representation in place, importers can unintentionally inherit compliance responsibilities, something many businesses are unaware of until problems arise. An Authorised Representative can help manufacturers by: ✔ Acting as a EU or UK contact point for authorities ✔ Holding Declarations of Conformity and technical documentation ✔ Supporting compliance with CE and UKCA marking obligations ✔ Helping streamline market access across Europe and the UK Following Brexit and the introduction of Regulation (EU) 2019/1020, ensuring the correct Economic Operator is identified has become a key part of product compliance strategy. Our sister company Authorised Representative Service supports manufacturers and importers in navigating these requirements. If you’re unsure whether your products require an EU or UK Representative, our team is happy to help. https://lnkd.in/eWZM34W9 #UKCA #CEMarking #ProductCompliance #AuthorisedRepresentative #EconomicOperator #Manufacturing #ImportExport #RegulatoryCompliance #MarketAccess

❓ Did you know that Machinery Safety Related Control Systems need to be validated? The standard EN ISO 13849-1 deals with the design of safety related control circuits and details of how the level of safety of a circuit can be calculated, this is known as the Required Performance Level or PLr. It describes how this performance level can be achieved using the following factors: ·       Circuit architecture (Category B, 1, 2, 3 or 4) ·       Mean time to dangerous failure (MTTFD) ·       Diagnostic coverage (DC) ·       Common cause failure (CCF) This process is known as verification and once this information has been used to design a suitable safety circuit then it must be ensured that the safety function actually works as intended, including under expected fault conditions. This latter process is known a validation. Validation ensures that the design process has met the specification, i.e. the achieved Performance Level is at least that identified as the PLr and confirms that the machine is safe under real world conditions. There are currently two valid versions of the standard EN ISO 13849-1. The version from 2015 simply refers to EN ISO 13849-2: 2012 for details of validation. The later standard from 2023 goes into the process of validation in detail but still refers to EN ISO 13849-2 for more specific details. Validation should be carried out by a person not involved in the design process. The steps in the validation process are: ·       Create a validation plan ·       Identify generic faults as found in EN ISO 13849-2 ·       Identify specific faults ·       Review of the safety requirements specification (SRS) Some of the validation can be done by analysis based upon the safety function, system architecture, MTTFD, DC and CCF, qualitative aspects which affect system behaviour, deterministic arguments, fault lists and criteria for fault exclusion. Testing is required and a test plan must identify the test specifications, the required outcome of the tests for conformity and the chronological order of the tests. Test records must be kept and compared to the test plan to ensure functional and performance targets are met. Tests should consider simulation of faults on both hardware and software, checks should be made that installed components correspond with the documentation. Validation is proof that the machine actually achieves the theoretical safety required and that in the event of a dangerous fault the machine is maintained in a safe state and ensures that personnel are not harmed. If you need any support please don't hesitate to contact us and speak to one of our machinery experts. https://lnkd.in/gxnNJ-vS #ENISO13849-1 #machinery #SafetyRelatedControlSystems

💡 Did you know that lifting equipment also falls within the scope of the Machinery Directive? The Machinery Directive (2006/42/EC) explicitly covers lifting accessories, including chains, ropes, and webbings. All are required to be CE/UKCA marked in accordance with the machinery legislation before being placed on the market or put into service, even for your own use. If you manufacture or use lifting equipment, you’ll know it presents some of the highest-risk scenarios in industrial environments. Failures can lead to serious injury, fatalities, and significant operational disruption. The Directive ensures these risks are addressed at the design and manufacturing stage and not just during use. You should know that: • Manufacturers of lifting equipment must CE/UKCA mark their products in accordance with the machinery legislation. • When purchasing lifting equipment, you should ensure it is CE/UKCA marked and supplied with a Declaration of Conformity. • Simple load testing and LOLER inspections are not sufficient, a CE/UKCA Declaration of Conformity and technical file are legal requirements. • What falls within the scope of the machinery legislation is not always obvious, and the definition does not always align with the LOLER Regulations. Bottom line: if your equipment lifts, lowers, or supports a load, it’s highly likely within scope. Ensuring compliance isn’t just about meeting regulations; it’s about protecting people and maintaining trust in your operations. #MachineSafety #MachineryDirective #liftingequipment #CEMarking #UKCAMarking #Compliance https://lnkd.in/eysEQZg7

Ensuring the safety and market readiness of electrical beauty devices isn’t just good practice it’s a regulatory requirement. Whether you’re launching a new product or importing devices into the UK and EU, understanding the nuances of CE and UKCA marking is essential to protect users and your brand. At Conformance, we help businesses navigate the complexities of product compliance, including CE and UKCA marking for electrical and electronic products. We support manufacturers and importers with assessments, declarations of conformity and clear guidance on applicable directives and standards so you can confidently place products on the market. Here are a few key points to consider: • Know your regulatory framework - CE marking confirms that a product meets EU legislation, typically involving safety, health and environmental requirements; UKCA marking does the same for Great Britain post-Brexit. • Product safety is non-negotiable - For electrical beauty devices, compliance with the relevant safety legislation isn’t optional. It’s part of your legal obligation as a manufacturer or responsible economic operator. • Documentation matters - A flawless Declaration of Conformity demonstrates that you’ve identified and applied the correct standards and requirements. Our team can help you prepare this and other technical files with confidence. If you’re bringing electrical beauty tech to market, don’t leave compliance to chance. Reach out to discuss how we can support your CE and UKCA marking journey. https://lnkd.in/gxnNJ-vS #ProductCompliance #CEMarking #UKCAMarking #ProductSafety #ElectricalDevices #beautyproducts

💡 What’s the link between CE Marking and PUWER? It’s a question that comes up often, and understanding the relationship is essential for anyone involved in machinery safety and compliance. CE & UKCA marking and PUWER (Provision and Use of Work Equipment Regulations) are closely connected but serve different purposes. •  CE / UKCA marking applies to a wide range of products and places responsibilities on manufacturers, importers and distributors in the EU and UK. These stem from directives and regulations that share a common framework, ensuring products are safe and suitable when placed on the market or put into service. •  PUWER, by contrast, focuses on the use of work equipment. It places a duty on employers to ensure equipment is safe throughout its lifecycle, regardless of when or where it was made. It also requires safety measures such as guarding and emergency stops, along with user training and proper maintenance. So where’s the link? The key connection is PUWER Regulation 10 - Conformity with Community requirements: •  This requires that work equipment complies with the essential requirements of the applicable community directives concerning the safety of products (such as CE or UKCA marking requirements) when first provided for use. •  CE or UKCA marked equipment is generally compliant with Regulation 10. If it is not CE or UKCA marked, the employer must demonstrate that it meets the relevant essential requirements.  •  CE & UKCA marked equipment is also more likely to meet Regulations 11–24 of PUWER. Here’s the key takeaway: Manufacturers are responsible for safety at the point of supply through CE and UKCA marking, while PUWER places responsibility on the end user. Using CE & UKCA marked equipment helps simplify PUWER compliance. However, CE marking alone does not guarantee PUWER compliance. Additional safeguarding, risk assessments or modifications may still be required. Older (non-CE/UKCA marked) equipment can still comply if it is safe to use. In practice: Organisations who want to ensure a safe working environment and legal compliance should treat CE/UKCA marking as the starting point and PUWER as the ongoing responsibility. Getting this right isn’t just about compliance, it’s about protecting people and ensuring equipment is fit for purpose every day it’s in operation. 📞 Need expert guidance on PUWER compliance? https://lnkd.in/gxnNJ-vS #MachineSafety #PUWER #CEMarking #HealthAndSafety #Engineering #Compliance

📣 New EU packaging regulation: What you need to know... The EU has introduced a Packaging and Packaging Waste Regulation (EU) 2025/40 (P&PWR), which will be a significant shift in how packaging is designed, assessed, and managed across the supply chain. Key dates to note: • Enters into force: 12th August 2026 • Transition period with existing Directive 94/62/EC: until 31st December 2029 A key change is a formal requirement for an EU Declaration of Conformity (DoC) for packaging and packaged products. This is a major departure from the current framework, where: • No “manufacturer” is clearly defined • No direct conformity obligations are placed on packaging manufacturers. The key implications for businesses are: ✔️New manufacturer responsibilities The definition of “manufacturer” now includes packaging and packaged products, meaning product manufacturers may fall within scope. ✔️ Mandatory conformity assessment A single procedure (internal production control) must be followed to demonstrate compliance with: • Sustainability • Safety • Labelling • Information requirements ✔️ No CE marking (but complexity remains) Unlike other EU legislation, packaging will not require CE marking, though overlaps with existing product legislation may create practical challenges. ✔️ Sustainability requirements increase Including: • Limits on harmful substances • Minimum recycled content • Enhanced labelling expectations • Reuse and refill obligations ✔️Extended Producer Responsibility (EPR) Most businesses in the supply chain will also be considered “producers”, meaning they must: • Register in each relevant EU Member State • Contribute financially to recycling schemes • Track and report packaging usage This aligns with broader EU goals under the Waste Framework Directive, moving towards a circular economy. If your organisation is involved in packaging whether as a manufacturer, importer, or distributor, now is the time to assess your position. Our consultant Mark Wilson has written an article which will provide you with more information.  https://lnkd.in/eFBzYrtp #packaging #CEmarking #declarationofconformity #PackagingWasteRegulation

We are seeing more and more enquiries coming in about the New EU Machinery Regulation (EU 2023/1230 - required for all Machinery placed on the market or into service from January 20th 2027), and how existing conformity assessments relate to the new updated legislation. Of course, this is our bread and butter at Conformance and we are well placed to perform gap analyses for our clients, to highlight where work is required to adapt, or improve systems to meet the new requirements where machinery is placed onto the European market. So we can help you with this, for example: Do you plug your machinery into a network? Does your machinery require persons to enter inside it during use, do you use machine learning during commissioning or operation? These are the kind of things we are helping clients with all the time, and you can contact us through our website for more information. But, while it is clear what is required for sale of machinery in Europe, what will happen to the UK legislation? How will this affect you if you are a UK manufacturer placing equipment solely onto the UK market? How will the UK Supply of Machinery (Safety) Regulations be amended once the new EU legislation is in force? Will we see divergence in the market requirements? Well, the UK Government has published its response to last year's call for evidence and consultation: https://lnkd.in/eMhDTUex No date has been given for updating the UK legislation, so divergence in UK / EU requirements is a possibility. A precedent was set in the Medical Device field - where UKCA and CE marks still use different primary legislation - so will you continue to use a CE mark to access the UK markets for your Machinery if a similar situation occurs? How will this affect your business? In our experience, EU/UK legislative divergence is a workable, if confusing scenario at times. We see situations where sticking to a UKCA only policy for UK market goods could be a sensible short-term business choice, we also see plenty of examples where conformity assessment to the Machinery Regulation is inevitable for our clients. But there's no doubt that UK Manufacturers need to be on top of their own decisions in advance of January next year. Don't wait - plan your strategy today!

At Conformance, our machinery safety consultants support manufacturers across a range of machinery safety activities, including CE marking and the safe design of machinery, assessing whether equipment meets the essential health and safety requirements of the Machinery Directive before it is placed on the market.   When we come across equipment and installations that appear compliant, but in service operators routinely defeat safeguards; whether by bypassing interlocks with spare keys or magnets, removing guard fixings, or otherwise working around protective measures, it always raises the same questions:   How could this have been made safer? What is it about the design that encourages people to defeat safeguards rather than work in a safe manner?   This often isn’t simply user refusing to follow a safe working procedure. It’s often a combination of:   • safeguarding design • operational needs • and maintenance requirements   The Machinery Directive requires the design of equipment to consider reasonably foreseeable misuse including the likelihood of guards being bypassed.   In practice, that means going beyond just use of compliant guards and fixings (e.g. EN ISO 14120), and considering in the design:   • how access is needed • how safeguards are used day-to-day • and how easily they can be defeated   Solutions are most effective when they combine:   • appropriate interlocking strategies • measures to prevent defeat • Consideration of usability   Once safeguards are routinely bypassed, the intended risk reduction is lost and operators are exposed to the underlying hazards. Designing for foreseeable misuse is therefore essential to ensure that safe working is the practical outcome, not just the intended one. Click below for more information on the machinery directive.  https://lnkd.in/eysEQZg7 #machinery #MachineryDirective #safeguards #CEMarking

Last week, our design engineers and project management team undertook CE mark training with Conformance Limited. 🧑🏫   💡 The CE mark, an abbreviation for Conformité Européenne (European Conformity), is a mandatory marking for many products sold within the European Economic Area (EEA), which indicates that the product meets EU health, safety, and environmental protection standards.   The training improved and reminded the team’s understanding of CE Marking and the essential regulations that the products we manufacture must comply with. 📃   🦺 By continuing to comply with CE marking regulations, our products have free movement within the European Economic Area, and meet the required safety & environmental protection standards, building trust and confidence with our customers.   👏 A big thank you to Chris Wordley who delivered the training to our team!   💻🔎 You can learn more about our compliance by visiting the link in the comments 👇   #CEMark #ProductCompliance #DesignEngineer #ProjectManagement #ComplianceTraining