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EU Compliance in 2025: CE Test Reports Aren’t Enough [Feat. Roberth Jonsson of 24HourAR]

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CE test reports alone don’t make you compliant in the EU or UK. In this episode, Sofeast CEO and host Renaud is joined by Roberth Jonsson Co-Founder of 24HourAR, to unpack who is legally the “manufacturer,” when you need a Responsible Person or Authorized Representative, and how GPSR, ESPR/Digital Product Passports, and the new Product Liability rules are tightening enforcement for importers and private-label brands.

 

Listen here

Listen to the episode or watch on YouTube

What you’ll learn in this episode

  • Why CE test reports ≠ full compliance (technical file, risk assessment, DoC, labeling, manuals).
  • Who is legally the “manufacturer” in the EU/UK (hint: private-label importers usually are).
  • When you must name a Responsible Person (often an Authorized Representative) and where it appears on the product/pack.
  • How GPSR, ESPR/Digital Product Passports, and Product Liability changes raise the bar for sellers into the EU.
  • Practical ways to avoid shipments being blocked by customs for missing documentation or contact details.

Episode Sections:

  • 00:00:13 – Introduction.
  • 00:03:20 – EU compliance at a high level: directives vs standards; CE ≠ everything.
  • 00:06:51 – Who’s the “manufacturer” legally? Private label importers beware.
  • 00:10:16 – Testing reports vs full compliance: technical file, risk assessment, manuals.
  • 00:12:26 – The “responsible person” & why it exists.
  • 00:14:18 – Market Surveillance Reg (2019/1020) and GPSR expanding the scope.
  • 00:17:41 – Importer obligations & the pain of sharing technical docs with many importers.
  • 00:20:03 – When to appoint an Authorized Representative (AR); DTC and online sellers.
  • 00:23:17 – Dropshipping into the EU: why customs may block you without an EU RP.
  • 00:25:15 – EU vs UK: similar rules, separate markets; you need separate reps.
  • 00:26:22 – “Can my cousin be the AR?” Contracts, duties, and… big risks.
  • 00:27:13 – Coming change: Product Liability Directive will add AR liability.
  • 00:29:19 – ESPR & Digital Product Passports; unified customs tools = tighter checks.
  • 00:33:05 – Gatekeepers: ARs/importers get pickier as liability rises.
  • 00:34:44 – How to contact 24HourAR.

Extra resources to dive deeper

  • CE Compliance for Manufacturing in Asia: A Beginner’s Guide
  • 11 Common Electronic Product Certification And Compliance Requirements
  • What is the EU Ecodesign for Sustainable Products Regulation?
  • 7 Upcoming EU Product Compliance Requirements (as of 2023)
  • New EU MDR: Who Are The “Economic Operators” For Imported Devices?
  • We’re Buying Medical Devices From China And Are Worried Our Supplier Isn’t Legit | Disputes With Chinese Suppliers Q&A (Volume 8)
  • Check out https://www.24hour-ar.com/ and learn about Roberth
  • Get help from Sofeast (quality, NPD, manufacturing, audits, inspections): https://www.sofeast.com/

🎧 Listen, rate, & subscribe to the ‘China Manufacturing Decoded’ podcast on your favorite provider

More episodes are on the way, so remember to rate us and subscribe! You can find us on:

CE Compliance for Manufacturing in Asia: A Beginner’s Guide

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Suppose you’re planning to manufacture a product in Asia and sell it in the European Union (EU). In that case, it’s crucial to understand CE compliance for manufacturing in Asia and the role of CE marking, even if you’ve never dealt with it before. CE marking is a legal requirement for many types of products; it shows your product meets EU safety, health, and environmental protection standards.

 

What Is CE Marking?

CE stands for Conformité Européenne, meaning “European Conformity.” If your product falls under one or more CE directives or regulations, it must bear the CE marking before it can be legally sold in the EU. This applies to a wide range of product categories, and in this article, we focus on non-medical electrical and electronic products.

Here’s the CE marking on a microphone, for example:

ce marking on product

There are specific CE marking requirements about the size and format of the symbol, how it should be applied (e.g., on the product itself or its packaging), and how visible it must be. You can read the official guidelines directly from the EU source: CE Marking Guidance – European Commission

But it’s MUCH wider than a couple of letters. CE is an entire compliance scheme!

 

Which CE Regulations Apply?

There isn’t just one regulation (note: technically there are both ‘directives’ and ‘regulations’, but for the purpose of simplifying things, let’s call them all ‘regulations’). Here are 4 examples:

  • Electromagnetic Compatibility Directive: Your product should not cause electromagnetic interference and must tolerate a certain level of interference from other devices. Requires testing.
  • Low Voltage Directive: Applies to electrical equipment within certain voltage ranges. Requires testing.
  • Radio Equipment Directive: Applies if your product includes wireless communication (e.g., Bluetooth or Wi-Fi). Requires testing.
  • RoHS Directive: This one applies to all electrical and electronic products. It limits the use of certain hazardous substances like lead, mercury, and cadmium. Technically, RoHS does not require lab testing, but we strongly advise you to test at least once to ensure compliance.

Other regulations may also apply depending on the nature of your product. For example, if the product measures a value as part of its function, if it is for use by children, or if it is intended to protect workers exposed to hazards.

Even if a consumer product does not fall under any of the CE regulations/directives, it falls under the General Product Safety Regulation, REACH, etc.

Is it used exclusively in the EU?

No, CE marking isn’t just for the EU, but for a wider area, the ‘European Economic Area’ (EEA).

It’s a good idea to consult an expert to determine exactly which directives and/or regulations are relevant in your case.

You can also read more about CE-related and other requirements here: 11 Common Electronic Product Certification And Compliance Requirements

 

How should the CE logo be affixed to products?

The placement of the ‘CE’ logo on products, as well as its size and legibility, are strictly regulated.

Affixing it on a product that does not fall under any of the regulations/directives that are related to the CE scheme is illegal. It is a sure way to catch the eyes of market surveillance authorities or a customs agent.

 

What is the CE Compliance Process?

Once you’ve identified the applicable regulations, here’s what you need to do:

  1. Assess conformity with the requirements of each regulation – that often means you must do testing against technical standard(s) related to the regulation and applicable to your product.
  2. Compile technical documentation, which typically includes drawings, test reports, risk assessments, a factory audit report, production inspection reports, etc.
  3. Prepare a Declaration of Conformity (DoC). This is a formal document where you (assuming you show your company brand on the product) state that your product complies with all relevant regulations. Note: that may include some other EU requirements that are not under the CE scheme, such as the REACH regulation.
  4. Apply the CE marking correctly to the product.

This is usually a self-declaration process for the example we picked above (non-medical electrical products), meaning you are responsible for making sure all requirements are met. There is a way to pick one of the authorized EU labs and get them to provide a certification for EMC, for example, but most SMEs avoid that approach because of the higher costs.

EU member states and the customs administrations will check imported product compliance at their own discretion. They may block a shipment if you can’t prove compliance with applicable requirements.

 

Final Tips

In general, don’t rely on second-hand information from random websites. The most accurate and up-to-date information is available on the official EU website.

Related extra information about CE Compliance for Manufacturing in Asia

Post-Brexit Compliance: Selling in the UK vs the EU. [Podcast]

Posted on by sofeast

If you’re manufacturing products for the EU and wondering how to break into the UK post-Brexit, this episode is for you. Renaud Anjoran sits down with compliance expert Fredrik Grönkvist from ComplianceGate to demystify the increasingly divergent regulatory frameworks between the UK and the EU.

They unpack why CE marking still holds weight in the UK, what has changed since Brexit, and how manufacturers and importers can navigate dual compliance without doubling their workload. Tune in to avoid costly assumptions and get practical insights that could save your next product launch.

 

Listen to the episode here

Listen: to the podcast episode

Watch: on YouTube

 

Episode sections

  • 01:01 – Guest Introduction – Fredrik from ComplianceGate
  • 02:06 – History of UK and EU Regulatory Alignment
  • 03:06 – Brexit and the Unfolding Regulatory Chaos
  • 05:00 – Brexit Formalization and Retained EU Law
  • 06:39 – CE vs UKCA Marking and 2023–2024 Changes
  • 08:01 – Northern Ireland vs Great Britain: Regulatory Differences
  • 08:52 – Selling in Both the EU and UK: What Should Importers Do?
  • 10:10 – Practical Approach to Compliance for Both Markets
  • 21:02 – Should You Use CE and UKCA Together on Products?
  • 24:55 – Final Thoughts and Wrap-Up

 

Related content…

 

Listen, rate, & subscribe to the ‘China Manufacturing Decoded’ podcast on your favorite provider

More episodes are coming, so remember to rate us and subscribe! You can find us on:

EU WEEE Directive: Introduction For Importers To Europe

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For companies that import electrical and electronic equipment (EEE) into Europe, another important to-do is complying with the EU WEEE Directive that tackles E-waste or WEEE.

We’ll introduce the EU Waste Electrical and Electronic Equipment (WEEE) Directive, how it affects you, what is needed to comply with it, the registration process, and more.

Continue reading “EU WEEE Directive: Introduction For Importers To Europe”

EU Batteries and Waste Batteries Regulation (2023): How Will It Impact Portable Electronics?

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The EU Batteries and Waste Batteries Regulation (2023) is going to impact a lot of the electronic products we work on for our customers if they are to be sold in the EU from about 2025; especially portable electronics. Battery sustainability, traceability, and recycling are becoming very important for products sold in EU countries. Let’s look into the regulation in more detail here so you can be prepared…

Continue reading “EU Batteries and Waste Batteries Regulation (2023): How Will It Impact Portable Electronics?”

7 New EU Product Compliance Requirements You Can’t Ignore In 2023

Posted on by sofeast

[vc_row][vc_column][vc_column_text]The next few years are going to throw a lot of challenges at importers who sell in Europe as there are quite a few new EU product compliance requirements coming into action either now (2023) or in the next few years.

To help you prepare, I decided to make a video talking you through 7 of the key EU product compliance requirements that are most likely to affect anyone manufacturing products.

As you can see, this was created under the banner of our product safety, reliability, and compliance lab, RSQ-Labs, as it’s the lab that often helps clients overcome compliance challenges like these.

 

EU product compliance requirements included

We cover 7 key requirements that you should know about:

  1. General Product Safety Regulation (2023/988) – applicable
    from 2024
  2. Ecodesign for Sustainable Product Regulation – applicable
    probably from 2025
  3. Corporate Sustainability Due Diligence Directive – applicable
    gradually over time
  4. Packaging & Packaging Waste Directive – applicable soon
  5. Battery & Waste Batteries Regulation – applicable from 2025
  6. Deforestation Regulation (2023/1115) – applicable from 2025
  7. New Directive on Liability for Defective Products – applicable
    from 2024

What you should do next if you import products into the EU…

We have a couple of pieces of advice for you if you sell into the EU (and that includes companies from, say, the USA, who will still be bound by these requirements).

  1. Watch the video above ☝️
  2. Download the presentation as it contains links to all of the EU’s literature for the above 7 requirements so you can do your own research. Here’s a download link 👇

[/vc_column_text][vc_btn title=”Download the presentation” color=”primary” align=”center” i_icon_fontawesome=”fas fa-file-powerpoint” add_icon=”true” link=”url:https%3A%2F%2Fbit.ly%2F47zhkSV”][vc_empty_space][vc_column_text]

Further reading/listening about EU regulations and requirements that may affect you

EU product liability directive

You can learn more about the EU product liability directive by listening to this podcast: Getting Ahead Of The Upcoming EU Product Liability Directive

You may also like: Exploring Product Safety & Reliability Issue Liability [Podcast]

Ecodesign for Sustainable Products Regulation

We’ve covered this regulation quite thoroughly as it’s a lot to grapple with for importers:

Sofeast is already helping clients with their EU Ecodesign Regulation Risk Assessment & Preparation as it involves getting complex supply chain information and making your product designs more sustainable…we can help you, too, so feel free to get a quotation.

Supply chain transparency and product lifecycle analysis

As will become apparent, you may need to obtain a lot more transparency in your supply chain than you currently have.

You will also benefit from doing a lifecycle assessment which is the most common methodology for assessing the potential environmental impacts associated with the entire life cycle of a product. We’ve also covered this:

Sofeast can also do your LCA for you: LifeCycle Assessment and Environmental Product Declaration Support (Measuring Product Environmental Impacts)

Additional EU requirement-related topics

[/vc_column_text][/vc_column][/vc_row]

Getting Ahead Of The Upcoming EU Product Liability Directive

Posted on by sofeast

Renaud hosts this episode on the EU’s forthcoming directive on product liability which should get you nervous if you sell into Europe.

Compliance expert Clive Greenwood and renowned legal and compliance expert Prof. Simon Choi join us today to discuss this proposal for a new version of the directive on this topic.

 

Listen to the episode here 👇

Listen: to the podcast episode

Watch: on Youtube

 

Our guests today:

  • Clive Greenwood, compliance counsel at Liangma Law Firm in Shenzhen, originally from the UK. Clive has been on this podcast a number of times. He has 30 years of quality assurance and compliance experience, with a special focus on EU compliance laws.
  • Prof Simon Choi has more than 30 years of international management experience. He is a senior lawyer in Hong Kong and the United Kingdom. He graduated from Peking University, University College London and the University of Hong Kong Law School. He serves as an independent director of many listed companies and has extensive legal education and practical experience around the world. He once served as the global legal director of TCL and led TCL towards internationalization for nearly ten years. In 2013, he was appointed as a co-professor of the School of Law at Zhongnan University of Economics and Law.

 

Episode sections

  • 00:00 – Greetings and introducing today’s topic.
  • 04:23 – What is the intent of the directive?
  • 06:53 – What does this directive change for economic operators on the distribution and retail side of things?
  • 12:47 – Transparency in the supply chain.
  • 16:56 – Even if a factory in, say, China can now be held liable for product problems as a supply chain actor under this new legislation, realistically, can an importer obtain compensation from them?
  • 24:47 – How the burden of proof for manufacturers is changing.
  • 28:45 – Product labelling must make it easier for any parties, especially consumers, to bring a case against a product’s seller.
  • 32:50 – Foreign manufacturers are going to be under a lot of pressure to change the way they do things.
  • 34:02 – Why the product safety’s burden of proof is on the party who brings the product into the EU.
  • 37:17 – Will this directive even be possible to enforce in manufacturing in China?
  • 39:38 – Wrapping up.

 

Related content…

 

Listen, rate, & subscribe to the ‘China Manufacturing Decoded’ podcast on your favorite provider

More episodes are coming, so remember to rate us and subscribe! You can find us on:

If you enjoyed this episode, don’t forget to give us a 5* rating and share it with your network if you enjoy listening!

What is the EU Ecodesign for Sustainable Products Regulation?

Posted on by sofeast

[vc_row][vc_column][vc_single_image image=”15549″ img_size=”full” alignment=”center”][vc_column_text css=””]The European Union is getting serious about sustainability and is already working towards ‘becoming a modern, resource-efficient and competitive economy where there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use.’ They aim to tackle over-consumption and reduce carbon emissions and waste by driving manufacturers to create “longer-lasting products that can be repaired, recycled and re-used.” The European Green Deal was approved in 2020 and is a set of policy initiatives put in place to achieve that goal. One of the initiatives is the EU Ecodesign for Sustainable Products (ESPR) regulation for the majority of products by May 2024. But what is this regulation and how does it affect importers?

Continue reading “What is the EU Ecodesign for Sustainable Products Regulation?”

The EU Ecodesign Regulation Is Coming, But Are You Prepared? [Podcast part1]

Posted on by sofeast

The EU Ecodesign Regulation Is Coming, But Are You PreparedSofeast CEO Renaud is joined again by friend of the show and product compliance expert, Clive Greenwood of SMC GLOBAL Manufacturing Consultants, to talk about the new ‘Ecodesign for sustainable products regulation’ set to become law in 2023 that will have a serious impact on importers of products into the EU, especially those made in Asia.

This regulation will require comprehensive supply chain information for all actors, assemblers, sub and sub-sub-suppliers, too. Do you know who they are?

It will also drive importers to produce more sustainable products with a focus on improving their circularity, energy performance and other environmental sustainability aspects. Again, are you ready to change course with all that entails (sourcing, new suppliers, certifications, etc)?

 

Listen here!

Listen: EU Ecodesign for Sustainable Products Regulation. How ready are YOU? (Feat. Clive Greenwood)

Watch: on Youtube

 

Episode sections

  • 00:00 – Greetings & Introduction to today’s topic
  • 01:19 – Some background.
  • 03:29 – What is the Ecodesign regulation going to be?
  • 07:12 – Verifying the supply chain
  • 17:12 – A LOT more due diligence will be required by buyers.
  • 21:00 – What’s the difference between an EU directive and an EU regulation?
  • 23:10 – Compliance with the Ecodesign for sustainable products regulation will be taxable.
  • 25:00 – Targeting ‘bad’ industries like Fast fashion.
  • 28:23 – How ready are YOU?
  • 33:01 – Traceability using a product passport.
  • 38:09 – The CSRD (EU Corporate Sustainability Reporting Directive) will replace the NFRD (EU Non-Financial Reporting Directive) reporting requirements starting in 2023.
  • 41:02 – What can YOU do to cope with these changes?
  • 44:40 – Summary of what the EU Ecodesign regulation focuses on. 
  • 45:40 – Wrapping up. 

 

A disclaimer…

We at Sofeast are not lawyers. What we discussed above is based only on our understanding of the regulatory requirements. We do not present this information as a basis for you to make decisions, and we do not accept any liability if you do so. Please consult a lawyer before taking action.

 

Related content

Next…jump straight into part 2 on this topic: How To Comply With The EU Ecodesign Regulation?

We’ve created some great resources on this topic – read them and get help here:

 

Listen, rate, & subscribe to the ‘China Manufacturing Decoded’ podcast on your favorite provider

There are more episodes to come, so remember to rate us and subscribe! You can find us on:

If you enjoyed this episode, don’t forget to give us a 5* rating and share it with your network if you enjoy listening!

EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]

Posted on by sofeast

EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]If you are developing a new medical device for sale in the EU, the EU MDR update affects you as you must now get it certified to the EU MDR regulation. 

But what is the path to get it certified? It very much depends on its ‘class’. 

In a previous article, we explained how to confirm if your product is considered ‘medical’ in the European Union. We also described the logic applied to determine how medical devices are classified.

In this article, let’s look at the path to certification for the different classes of medical devices in this new EU MDR update.

Continue reading “EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]”