CE Marking: Understanding Which Directives Apply to Your Product
John Showell
Product compliance management, consultancy, testing; software (Comply Express SmartCert); EU & UK Authorised Representatives; Product assembly services
In our recent post #13, we covered why CE marking is essential and how it enables free movement of goods within the EU market (a reminder CE also covers the GB market). But before you can start the CE marking process, there’s a critical first step—identifying which EU directives and /or regulations apply to your product.
This is where many businesses can get stuck. CE marking ??????’?? ?? ???????????? ????????????????????—it’s an extensive framework that spans ???????????????? ???????????????????? ?????? ??????????????????????, each with its own requirements.
???????? ??: ???????? ???????? ?????????????? ?????????????? ???? ???????????????
Not all products sold in the EU require CE marking – and where CE marking doesn’t apply, it would be an offence to apply the CE mark. The key is determining whether your product falls under one or more ???? ?????????????? ???????????????????? ??????/???? ??????????????????????. Here are some common product categories:
? ???????????????????? ?????? ???????????????????? ?????????????????? → Low Voltage Directive (LVD), EMC Directive
????????????????? ????????????????→ Radio Equipment Directive (RED). ???? RED brings in LVD (without any lower voltage limit) and EMC
? ?????????????????? → Machinery Directive
? ?????????????? ?????????????? → Medical Devices Regulation (MDR)
?????????, ??????, ???????????????? ??????????????????, ???????????????????????? ???????????????? → Various product-specific directives
Some EU laws, like the ?????????????? ?????????????? ???????????? ???????????????????? (????????) or ???????? ??????????????????, impose legal obligations but ???? ?????? ?????????????? ???? ??????????????.
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???????? ??: ???????????????? ???????????????? ???????????????????? & ?????????? (?????????????????? ???????????? & ???????????? ????????????????????????)
Each directive / regulation has its own scope, ???????? ???????????????????? ????????????????, ?????? ???????????????????? ????????????????????????. Here’s an example:
?? ?? ???????????? ???????????????? typically needs to comply with:
Note that the 'RED' encompasses consideration of the essential safety and health requirements of the Low Voltage Directive ('LVD') and the electromagnetic compatibility directive ('EMCD') and an important point about the product's 'DoC' (declaration of conformity) is that in this case declaration of the RED will be sufficient and it is incorrect to additonally cite the LVD and EMCD. DoC's need carefully preparation and review. It's a good idea to get a professional independent review of the DoC format and content and also the related supporting legal evidence in the 'Technical File' if you are unsure about any of these subjects. Note that for some types of products, it is mandatory to have this professional review by use of an official EU 'Notified Body'. More about this process in a future article.
Your product may well require compliance with multiple directives / regulations simultaneously.
Step 3: Understanding "Harmonised Standards"
Once you identify the directives? / regulations, the next step is checking harmonised standards—technical rules that define the specific essential safety requirements for compliance for the type of product. Using harmonised standards simplifies the process because products claimed to comply 100% fully with these specific standards benefit from a presumption of conformity with the associated directive / regulation under EU law.
?? Have you encountered challenges identifying which directives / regulations apply to your product? Share your experience in the comments!
?? Next up: Breaking down the Low Voltage Directive (LVD) – What it is, what it covers, and how to comply. Stay tuned! Follow us.
Business Development Manager - International Type Approval / GMA - Global Market Access / Customer Service Consultant EMC & Product Safety
3 周Be careful, there exist several circumstances where the use of a harmonized Standard does Not provide a presumption of conformity. For example All cases that require a notified body additionaly. - examples: Gas APPLIANCES, medical classic 2 or 3 and so on. Do you agree?
Product Safety and Regulatory Specialist
3 周I recognise that you're presenting a simple approach here, but I think that what you've written could perpetuate confusion over the application of RED vs EMC+LVD. It is not correct to cite both RED and EMC+LVD on a Declaration of Conformity, as your Step 2 example implies. When RED applies to a product, it takes over the safety and EMC requirements from the EMC and LVD directives. Yes, we use the essential requirements of the EMC + LVD directives, but the legal basis of that is all included in RED. It's a particular nit-picking point that was hammered into me by my mentors! Of course, it makes little difference to the testing and standards that we need to apply, but it's important to get that Declaration of Conformity right, because it's often the first thing the enforcement authorities will look want to at.
Let a good product compliance management turn technical barriers to trade into competitive advantage ?? for a successful Global Market Access !
3 周... and regulations ! ;-) Very nice step by step process, thank you for sharing