The EU's New Legislative Framework

What it is, why it matters, and where it is heading

New Legislative Framework (NLF)

When a product is sold in the European Union, e.g., a smartphone, a child's toy or a tractor, it must meet a set of safety and quality requirements. How these requirements are set, checked, and enforced across 27 different countries is what the New Legislative Framework (NLF) is designed to address.

The EU introduced the NLF in 2008. It is a set of legal acts that complements and strengthens the EU’s approach to product legislation in the European Single Market. The NLF only prescribes essential requirements reflected in basic EU product legislation and voluntary harmonised standards. Unlike many other countries or regions worldwide, there are no mandatory standards in the EU unless they are explicitly referenced in laws or private contracts. The NLF strengthens the overall coherence and consistency of EU legislation, as well as the notification process (the formal procedure for designating conformity assessment bodies), accreditation, conformity assessment procedures, and market surveillance.

The NLF consists of Regulation (EC) 765/2008 (on accreditation and market surveillance), Decision 768/2008 (on CE marking principles, notifying and notified bodies, and conformity assessment procedures), and Regulation (EU) 2019/1020 (update on market surveillance and the compliance of products). The NLF is not itself a product law; it is the common rulebook on which all EU product laws are based. It defines who is responsible for what (manufacturers, importers, and distributors each have specific duties), how a product is certified as safe (via conformity assessment), what the CE marking means, and how national authorities monitor and enforce compliance (via market surveillance).

The NLF supports the free movement of goods within the European Single Market. It includes mutual acceptance of conformity assessment results, e.g., test reports and certificates issued by conformity assessment bodies officially notified by EU member countries. This follows the ‘one standard, one test, accepted everywhere’ principle. For example, in Albania, a manufacturer of medical devices can use harmonised EU standards and NLF-aligned national legislation to prepare products for future access to the EU single market, reducing the need for redesign or repeated testing once EU recognition arrangements are in place.

Before the NLF, EU product laws used inconsistent terminology, varied procedures, and differing standards of accountability. The NLF unified all of this into a single, coherent system that any sector-specific law, from medical devices to construction products, can plug into directly.

Unique features of the NLF

Most large economies regulate the product safety sector by sector, with different agencies, rules, and procedures for different types of goods. The United States, for instance, has separate regimes for consumer products, electrical equipment, food and drugs, etc. These systems can be inconsistent and difficult for manufacturers to navigate across product categories. Also in the Western Balkans accession countries, before alignment with the NLF, product regulation was typically fragmented across multiple sectoral ministries and inspectorates, with each authority applying its own technical rules, approval procedures, and often duplicative testing requirements.

The NLF takes a fundamentally different approach. It creates a single horizontal layer of common rules that underpins all product legislation. This means a company selling both toys and industrial machinery in the EU faces the same underlying legal logic for both, even though the specific technical requirements differ. This consistency reduces complexity and cost, particularly for businesses operating across multiple product categories.

The NLF works with the proven approach of combining technical regulations (determining the ‘what’) with voluntary harmonised standards (determining the ‘how’). The idea behind combining voluntary standards with mandatory legislation is to facilitate deregulation: the more enterprises self-regulate using harmonised standards, the fewer authoritative regulations are needed.

A second distinctive feature is the CE marking. This small symbol, found on all products sold in the EU that pose inherent risks to the general public, is not a quality badge or a third-party safety seal. It is a legal declaration by the manufacturer that the product meets EU requirements. It functions as a passport: once a product carries it legitimately, it can be sold freely across all 27 EU member states without additional national checks. No comparable single-market access mark exists in any other major trading bloc with equivalent legal weight.

Third, the NLF offers a flexible, risk-based approach to product certification. Not every product needs to be tested by an independent laboratory. Lower-risk products can be certified by the manufacturer alone; higher-risk products require the involvement of an accredited third-party body, a notified body. This calibrated system avoids the one-size-fits-all mandatory third-party testing that characterises some other regulatory regimes.

Finally, the NLF has become a model for the world. After Brexit, the United Kingdom retained the NLF structure (with its own UKCA marking replacing CE). Countries seeking to join the EU, such as the Western Balkan countries, are already aligning their national product legislation with the NLF as part of their accession process. No comparable framework from the US, China, or ASEAN has achieved this level of voluntary international adoption.

For EU accession countries: Aligning with the NLF is not optional; it is a requirement for EU membership. This means adopting not just the technical standards, but the entire legal architecture, including conformity assessment procedures, notified body designation, market surveillance powers, and CE marking rules.

Eight conformity assessment modules

At the heart of the NLF is the question: how do we know a product is safe before it reaches consumers? The answer depends on the product's risk level. For a simple extension lead, a manufacturer's own declaration may be sufficient. For a pacemaker implanted in a human heart, much more rigorous independent verification is required.

The NLF provides eight standardised assessment routes, called modules, labelled A to H, that legislators can choose from when drafting product-specific laws. They are like a menu of increasing scrutiny, from self-certification at one end to full independent oversight at the other.

Module A is the simplest route. The manufacturer carries out all checks internally, signs the Declaration of Conformity, and affixes the CE mark. No external body is involved. This is used for lower-risk products such as basic consumer electronics or simple protective equipment like gardening gloves.

Module B is a gateway step rather than a complete route. An independent accredited body (a notified body) examines a representative sample of the product design (the 'type') and issues a certificate. Module B covers only the design; it must always be paired with one of four production modules (C, D, E, or F) to describe how the product is actually manufactured.

Modules C, D, E, and F sit alongside Module B and cover the production phase with increasing levels of external oversight. Module C requires no notified body in production. Module D involves a notified body auditing the manufacturer's production quality system. Module E involves auditing the finished product quality system. Module F involves a notified body directly sampling and testing finished products.

Module G is reserved for unique or one-off high-risk products, e.g., a custom-built industrial pressure vessel or a large crane designed to individual specifications. Because each unit is different, there is no 'type' to certify; instead, the notified body examines and certifies every single unit individually.

Module H is the most comprehensive route for serial (mass) production. The notified body audits the manufacturer's entire quality system, covering design, production, and final inspection, eliminating the need for a separate Module B-type examination. This is used for the most safety-critical manufactured goods, such as implantable medical devices.

Source: https://www.dke.de/en/standards-and-specifications/standardization-law/conformity-assessment

These modules are not mandatory; product legislation typically offers manufacturers a choice of 2 or 3 routes, depending on the product's risk level. This flexibility is one of the NLF's most important features: it avoids prescribing a single method. Instead, it lets manufacturers find the most efficient path to compliance within a bounded set of options.

For EU accession countries: When transposing NLF-aligned EU directives into national law, these eight modules must be transposed exactly as defined. Notified bodies in an accession country must be formally designated and notified to the Commission before they can issue certificates valid for CE marking.

The EU Omnibus Package and its implications for conformity assessment

In November 2025, the European Commission published the Digital Omnibus Package, a set of measures aimed at simplifying and clarifying how existing EU digital legislation, including the AI Act, interacts with the NLF product safety framework.

The most practically significant clarification resolves a question that had been causing uncertainty for manufacturers of AI-enabled products: when does the AI Act apply, and when does sector-specific product law apply? The Omnibus confirms that where a product is already covered by NLF-aligned sectoral legislation, such as the Medical Device Regulation or the Machinery Regulation, the conformity assessment under that sectoral law takes precedence. AI-related requirements must be integrated into the existing NLF conformity assessment procedure rather than run in parallel. For manufacturers, this is good news: it means one conformity assessment rather than two.

The Omnibus also streamlines the designation of notified bodies. Bodies that wish to be designated to carry out conformity assessment under both the AI Act and an existing sectoral regulation can now submit a single combined application and undergo a coordinated assessment. This reduces duplication and cost for the notified body ecosystem, which is already under capacity pressure in several member states.

More broadly, the Omnibus reflects the central tension running through the entire current reform cycle. On the one hand, there is pressure to make EU product regulation more ambitious by adding sustainability requirements, digital traceability, and AI governance. On the other hand, the Draghi Report's competitiveness agenda warns that regulatory complexity is undermining EU industrial competitiveness and calls for significant simplification. The Omnibus attempts to reconcile these two imperatives: reducing administrative burden without weakening the substantive protection standards that the NLF was designed to guarantee. How successfully it achieves that balance will be tested as the European Product Act moves through the legislative process in 2026.

For EU accession countries: The Omnibus changes are particularly relevant for countries transposing the AI Act alongside NLF product legislation. The integration principle means you do not need to create parallel national conformity assessment procedures for AI-enabled products; existing NLF-based procedures should be adapted to absorb AI Act requirements.

Current NLF reform plans and debates

The NLF is now undergoing its most significant review since its introduction in 2008. The European Commission is developing what it calls a European Product Act, effectively a comprehensive update to the NLF, with a formal proposal expected in mid-2026 and adoption expected to follow through the ordinary legislative procedure, likely over several years.

Five major debates are shaping this reform. The first concerns Digital Product Passports (DPPs). Under current rules, product information (technical documentation, test results, declarations of conformity) is available in paper or static digital form. The reform would replace this with a machine-readable digital record attached to each product, accessible by regulators, businesses, and consumers. This would make compliance checking faster and more transparent, but critics warn it could also increase the administrative burden on manufacturers, especially smaller ones.

The second debate is about the circular economy. The NLF was designed around a single moment: when a product is first placed on the market. But in a world where products are increasingly repaired, refurbished, and resold, the question arises: who is legally responsible for a product's compliance after it has been modified or recycled? The current framework provides no clear answer, and the reform must address this gap.

The third challenge involves software and artificial intelligence. Many modern products, e.g. cars, medical devices, and industrial machinery, are increasingly defined by the software running inside them. A software update can change a product's behaviour and safety profile after it has already been certified. The existing conformity assessment modules (see below) were not designed with this in mind, and new rules are needed.

The fourth and most politically contentious debate is about standards. The NLF relies on harmonised technical standards produced by European standards bodies such as CEN/CENELEC to provide manufacturers with a practical path to compliance. When those standards are delayed or unavailable, the Commission has increasingly substituted its own 'common specifications', which are Commission-issued acts that bypass this process. Industry strongly opposes this, arguing it undermines the collaborative, industry-driven standardisation model that has been a cornerstone of the NLF since its inception.

The hidden 5^th driver behind the NLF revision is that the system is reaching the limits of its original architecture. Instead of consolidating the system across all the legislation, there are increasingly conflicting rules. Potential conflicts between the EU regulatory regimes on radio equipment, cybersecurity, and AI are particularly relevant. Manufacturers now face overlapping obligations across conformity assessment, cybersecurity, software updates, documentation, and market surveillance stemming from multiple legal instruments developed in parallel rather than as a single integrated architecture. These risks recreate the kind of fragmentation the NLF originally aimed to eliminate. It is not an accident that the revision is presented as the ‘European Product Act’ (‘Act’ as a singular!). The desire to simplify and consolidate is tangible.

References:

1. Decision No 768/2008/EC on a common framework for the marketing of products (the NLF's core instrument, containing the eight conformity assessment modules in Annex II)

2. Regulation (EC) No 765/2008 on accreditation and market surveillance (the companion regulation to Decision 768/2008)

3. Regulation (EU) 2019/1020 on market surveillance and compliance of products (replaced the market surveillance provisions of Regulation 765/2008)

4. Regulation (EU) 2024/1689 — the AI Act (first comprehensive AI regulation globally, directly relevant to NLF conformity assessment integration)

5. The Blue Guide on the implementation of EU product rules 2022 (the Commission's primary non-binding reference document explaining CE marking, conformity assessment, notified bodies, and market surveillance — essential reading for practitioners and accession countries)

6. Commission NLF overview page — DG GROW's live page listing all 23+ pieces of NLF-aligned legislation with links to each.

7. SWD(2022) 364 final — Fitness check/evaluation of the NLF (the formal evaluation that identified the circular economy gap and digital shortcomings, underpinning the reform agenda)

8. SWD(2022) 365 final — Full staff working document accompanying the evaluation (detailed evidence base, case studies, stakeholder analysis)

9. Mario Draghi, "The Future of European Competitiveness" (September 2024) — the report that has most directly shaped the Commission's current legislative agenda, including the European Product Act and simplification drive

10. Enrico Letta, "Much More Than a Market" (April 2024) — the companion report on the future of the Single Market, providing context for the NLF reform within the broader single market agenda

11. TAIEX and EU accession alignment guidance — the Commission's technical assistance programme that helps candidate countries align product legislation with the NLF

12. SOLVIT and Single Market Scoreboard — tracks how well member states (and candidate countries) implement single market rules in practice

13. Centre for Strategy & Evaluation Services and Centre for Industrial Studies, Supporting Study for the evaluation of certain aspects of the New Legislative Framework, May 2022.