Selling products across Europe demands rigorous compliance with EU directives, CE marking requirements, and now an evolving
We also compare Nemko’s approach with that of several large international testing and certification organizations that dominate the European market. These include long-established technical inspection groups known for their structured, process-heavy methodologies, as well as global conglomerates whose vast networks emphasize volume and scale over flexibility.
In contrast, Nemko stands out through technical depth, responsiveness, and a partnership-driven approach. Backed by insights into EU regulatory trends and public data, we simplify the path to compliance and help you achieve approvals quickly and confidently. In a region where one missed detail can delay market access across 27 countries, our goal is to provide clear, actionable steps to meet European standards and reach the market efficiently. From CE marking strategy to leveraging mutual recognition, this serves as your roadmap to success in Europe.
The European Union’s approach to product regulation has long been a model of integration. Under the New Approach principles established in the 1980s, now formalized as the New Legislative Framework, the EU sets essential requirements for health, safety, and environmental protection, and manufacturers demonstrate conformity, often by affixing the CE mark. For most products in lower risk categories, CE marking is based on self-declaration. The manufacturer or authorized representative ensures the product meets all relevant EU directives and regulations such as the Low Voltage Directive, EMC Directive, and Machinery Regulation, and signs an EU Declaration of Conformity. Only higher-risk products like gas appliances, medical devices, and certain machinery require a Notified Body to test or certify before CE marking. This framework allows free movement of goods across the EU and EEA. Once your product is CE marked, it can be sold in any member state without additional national approvals.
However, the framework continues to evolve. Technology advances and new priorities are prompting updates. In recent years, the EU introduced or revamped regulations to address emerging risks. The Radio Equipment Directive is being updated to include cybersecurity provisions for wireless devices. The Medical Device Regulation and In Vitro Diagnostic Regulation raised the bar for clinical evaluations and post-market surveillance. Sustainability has come to the fore with initiatives like the Ecodesign for Sustainable Products Regulation and stricter RoHS limits. In late 2024, the EU implemented a new General Product Safety Regulation to strengthen consumer product safety oversight. As of November 2025, the European Commission is reassessing the CE marking framework in light of rapid tech development and environmental goals. Objectives include improving market surveillance, clarifying digital compliance documentation, and enhancing the toolbox for member states to enforce rules. For manufacturers, this means compliance is becoming more digital and more comprehensive. New requirements can emerge, such as the upcoming AI Act and Cyber Resilience Act, which will impose obligations on smart products.
Staying compliant in Europe is an ongoing process. Companies must track changes to directives and harmonized standards. A current example is the transition from the old Machinery Directive to the new Machinery Regulation (EU) 2023/1230, which modernizes requirements for robotics and AI in machinery and will fully apply by 2027. The UK’s departure from the EU also introduced the UKCA mark for Great Britain, which largely mirrors CE requirements but adds planning considerations for EU exporters.
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Nemko’s insight: We advise clients to adopt a proactive compliance strategy. Design for compliance by aligning with the latest EN standards. Engage in pre-compliance testing to catch issues early. Nemko’s experts often perform a CE readiness check at the design stage, reviewing documentation and test results against all applicable EU requirements to avoid surprises when it is time to sign the Declaration of Conformity. Nemko has been involved in EU conformity assessment since the early days of CE marking. Our teams interpret gray areas and guide manufacturers on the most efficient conformity modules. The goal is to get the CE mark on your product with minimal friction, opening the European market. FEATURED BLOG: What influences the cost of CE marking? |
Europe’s regulatory environment is moving with two major trends. The first is digitalization. As products become smarter and more connected, the EU is integrating cybersecurity and software updates into compliance. The Radio Equipment Directive’s delegated act on cybersecurity, effective August 2025, will require wireless products to meet network resilience, data protection, and privacy provisions. The proposed Cyber Resilience Act will mandate baseline cyber protections for products with digital elements. Manufacturers should prepare for cybersecurity risk assessments and stronger software documentation as part of the technical file. The EU is also considering digital CE marking methods to complement or replace physical markings for some products, which could streamline documentation.
The second trend is sustainability. The Ecodesign for Sustainable Products Regulation expands ecodesign principles beyond energy efficiency to include durability, reparability, recyclability, and carbon footprint. Existing frameworks such as EU RoHS and REACH restrict hazardous substances, and the Waste Electrical and Electronic Equipment Directive imposes recycling obligations. Compliance now looks at the entire product lifecycle. Companies are calculating recycled content and planning for national programs like repairability scoring. Nemko helps integrate eco-design requirements early, which supports compliance and can reduce cost through better material and design choices.
Safety remains central. Standardization work continues to refine safety benchmarks. A recent update is EN IEC 62368-1 (4th edition) for audio-visual and IT equipment safety. Transition timelines mean manufacturers must update certifications to this new standard in the coming years. Nemko hosts webinars on such changes to guide companies through recertification and avoid lapses.
The European TIC market includes several well-known players. Several large international testing and certification agencies dominate the European market. These include giant organizations based in Germany, France, UK and Switzerland and other multinational firms known for their vast networks and corporate scale. While their size allows for wide service coverage, it can also result in slower processes and less personal interaction. Nemko, by contrast, remains focused and responsive, offering direct access to experts and close working relationships that large corporations often struggle to match.
So, where does Nemko stand out for Europe? Credibility and personalized service. While we are smaller than the largest players, Nemko’s name carries weight in specialized sectors. We are an EU Notified Body for several directives and offer agility with direct access to experts. Many enterprises report that in large organizations projects can move slowly through layers. With Nemko, responses are fast and senior engineers stay engaged from inquiry to certification. Clients cite reliable processes and strong technical competence.
Another differentiator is Nemko’s proficiency in complex, multi-regulation projects. For example, a connected medical device needed CE marking under the Medical Device Regulation, RED wireless requirements, and RoHS and Ecodesign compliance. We coordinated all aspects under a single plan. Nemko’s cross-disciplinary coordination helps keep testing unified and efficient across safety, EMC, wireless, and chemical analysis.
Nemko also differentiates on speed and first-time success. We front-load reviews to reduce back-and-forth with Notified Bodies or authorities. As larger providers invest in dashboards and platforms, Nemko combines efficient tools with a dedicated engineer who knows your product. The outcome is faster approvals and fewer surprises.
Europe remains a cornerstone market. By understanding the CE system, tracking regulatory changes, and selecting the right partner, companies can turn European standards into an advantage. Nemko offers deep European expertise, accredited labs, and a customer-centric approach to guide you through every directive, standard, and test.
With Nemko’s guidance, you can place the CE mark with confidence and unlock the European single market.