Know exactly what compliance will cost before you commit

Verify on EU NANDO database: (1) Notified under Regulation 2016/425, (2) Specifically notified for your product type (respiratory ≠ gloves ≠ footwear), (3) Capacity/lead times (request written timeline commitments), (4) Specialization in your PPE type, (5) Dual EU/UK accreditation if pursuing both markets.

Red flag: "voluntary certificates" from non-notified bodies have zero legal value.

Category I: No.

Category II: Yes (Module B type-examination only).

Category III: Yes (Module B + ongoing Module C2/D surveillance).

All certificates expire after 5 years, renewal requires 6-12 month advance notice. Cost: €8K-€15K for Module B, plus €3K-€10K annually for Category III surveillance.

CE = EU market access (27 countries + Northern Ireland).

UKCA = Great Britain access (England, Scotland, Wales).

Since August 2024, UK accepts CE marking indefinitely for PPE, but this could change. Smart manufacturers get both to hedge policy risk. Requirements are nearly identical; separate bodies needed.

Category I: 2-4 weeks (self-certification).

Category II: 3-5 months (Notified Body type-examination).

Category III: 5-8 months (type-examination + surveillance setup).

Main delays: incomplete technical files (adds 2-4 months), Notified Body backlogs (adds 6-12 months), wrong risk category (forces restart).

CE marking proves compliance with EU Regulation 2016/425, required for all EU sales.

Category I PPE (minimal risk) = self-declaration.

Category II/III = Notified Body certification required.

For Category III, CE mark must include Notified Body's ID number.

Note: CE marking confirms regulatory compliance, not quality.

Yes. Most products under the EMC Directive follow internal production control, provided technical evidence supports conformity.

Yes. Battery-powered products can emit disturbances and must also be immune to interference.

The applicable EMC standard depends on product type, environment, and function. Product-family standards take priority.

Harmonised EMC standards are not legally mandatory, but using them provides a presumption of conformity with the EMC Directive.

EMC standards required for CE marking are the harmonised EN standards that apply to your product’s category, environment, and function. These typically include emissions and immunity standards such as EN 55032, EN 55035, or the EN 61000-6 series.

UKCA follows a similar structure with comparable cost drivers. Products sold in both the EU and UK typically require both certifications, which roughly doubles the compliance effort and cost.

CE marking does not expire on its own. However, it remains valid only as long as the product design and applicable regulations stay unchanged. Product modifications or regulatory updates may trigger reassessment.

You address the non-conformities—whether that means design changes, shielding improvements, or documentation updates—then retest. Re-testing adds both time and cost, which is why thorough preparation before testing matters.

The EU does not charge a fee for CE marking itself. All costs come from testing, documentation preparation, consultants, and Notified Bodies when required.

Timeline depends on product complexity, testing requirements, and documentation readiness. Simple products might complete the process in 4–6 weeks. Complex products or those requiring Notified Body involvement often take 3–6 months or longer.

Define worst-case configuration early, run pre-compliance scans, enforce configuration traceability, and retest only relevant subsets after targeted fixes.

Charging introduces conducted noise, transient events, and cable coupling effects. In battery-powered devices, charging mode is often the EMC worst-case configuration.

Ferrites can help when cable coupling is the dominant path, especially for radiated emissions issues. They are less effective for power-entry conducted noise problems.

Emissions failures occur when the device emits excessive interference (conducted/radiated). Immunity failures occur when the device malfunctions during disturbance tests (ESD/EFT/surge/RF immunity).

Power supply noise and uncontrolled cable configuration are the most common causes. Many failures happen because the product is tested in a mild “demo setup” rather than worst-case configuration.

Choose labs based on accreditation scope, product category experience, test plan discipline, configuration traceability, retest policy, report quality, and scheduling reliability.

Standard references, complete test setup details (cables, PSU, operating mode, firmware), measurement results, traceability, and clear conclusions usable for the Technical File.

Common causes include wrong worst-case configuration, poor setup traceability, incorrect operating mode, and insufficient immunity robustness (ESD/EFT/surge issues).

Testing usually takes 3–10 days, but booking lead times and report issuance can extend to several weeks. Retesting often adds 1–2 additional weeks.

Accredited labs are strongly recommended because they improve evidence credibility and reduce audit risk. What matters most is that the lab’s accreditation scope matches your required tests and standards.

Choose labs based on accreditation scope, product category experience, test plan quality, configuration traceability, retest policy, report quality, and lead times.

At minimum: standard references, clear test setup configuration, cable and PSU details, operating mode, firmware version, measurement results, and conclusions.

Common causes include incorrect worst-case configuration, poor test plan discipline, wrong operating modes, and insufficient immunity robustness.

Testing typically takes 3–10 days, but lead times for booking and reports can extend the process to several weeks. Retesting often adds additional time.

Accredited testing is strongly recommended because it increases credibility, reduces risk during audits, and improves report defensibility for Technical Files.

Accredited lab testing commonly takes 3–10 days, plus time for reports and possible retesting. Pre-compliance scans can reduce delays.

Standards selection rationale, test plan configuration traceability, emissions and immunity test reports, DoC references, labeling/instructions, and change control.

Typically conducted and radiated emissions plus immunity tests such as ESD, EFT/burst, surge, RF immunity, and voltage dips (for mains-powered equipment).

Most electronic equipment requires EMC evidence as part of CE marking, though requirements vary by product type, environment, and applicable standards.

An EU directive requiring electronic equipment to meet electromagnetic compatibility: it must not emit excessive interference and must tolerate disturbances in its environment.

Common outcomes include customs holds, marketplace suspension, authority requests with short deadlines, and potential withdrawals/recalls and fines under national enforcement law.

Sometimes—only if they are legally the importer (or otherwise assume obligations) and are willing to be identified as such and cooperate with authorities.

No. EU establishment is about where the company is legally incorporated/registered, not where inventory is stored or staff are located.

If you are a non-EU manufacturer selling regulated products and you are the seller of record using EU fulfilment, you often need an EU AR unless a legal importer is clearly assuming importer obligations.

No. The AR cannot certify, redesign, or “fix” compliance. The manufacturer remains responsible; the AR supports documentation availability, cooperation with authorities, and correct execution of regulatory processes.

Typically: EU Declaration of Conformity, technical documentation/technical file, test reports, risk assessment, labeling/IFU, change history, and complaint/incident records—so they can be provided to authorities on request.

No. An importer places products from a non-EU country on the EU market and carries importer obligations. An AR is appointed by mandate to perform specific tasks; it does not take ownership of goods or replace the manufacturer’s responsibility.

You may need an EU AR when you are a non-EU manufacturer placing regulated products on the EU market and there is no EU-established economic operator (often an importer) assuming the required compliance responsibilities under the applicable legislation.

A legal entity established in the EU appointed by a non-EU manufacturer via a written mandate to perform specific compliance tasks—mainly holding technical documentation and cooperating with market surveillance authorities.

Yes, if they have legal establishment and operational capability on both sides. Bundling can reduce admin overhead, but only if mandate scope, document control, and authority-response procedures are clearly defined.

For many goods, Northern Ireland follows EU rules, including CE marking where applicable. UKNI marking is used in specific conformity assessment routes involving UK bodies for NI.

If you sell into both the EU and Great Britain, you typically need EU-side economic operator coverage and UK-side economic operator coverage. Whether those are service providers depends on your supply chain (importer model vs direct seller / marketplace model).

Not universally. “Responsible Person” is used mainly in sector-specific UK frameworks (e.g., cosmetics, medical devices). For many product regimes, the key requirement is having a UK-based economic operator (often the importer), and sometimes a UK authorised representative model.

For many goods, the UK continues to accept CE marking in Great Britain. However, acceptance of CE marking does notremove the need to have the correct UK-based economic operator structure and UK obligations for the product regime.

Pricing depends on number of SKUs/categories and whether the AR provides only a mandate + storage or also supports authority requests, incident coordination, translations, and document control.

At minimum: scope of products, exact tasks, documentation access/retention, response process for authority requests, change update rules, incident support, and termination/handover terms.

Not necessarily. “Responsible economic operator” terminology appears in EU frameworks like GPSR; an AR can be one route, but roles and duties depend on the applicable legislation.

An importer places products from a non-EU manufacturer on the EU market and carries legal obligations. An AR is appointed by mandate to perform specific tasks, typically documentation availability and authority cooperation.

You need an EU-established economic operator who can cooperate with authorities and provide documentation when required. Depending on product legislation and your supply chain, that operator can be an AR, importer, manufacturer in EU, or fulfilment provider.

If you’re based outside the EU or UK, yes, it’s mandatory.

‍EcoComply is certified to act as your EU & UK Authorised Representative, handling authority requests and document retention for you.

You don’t need to. We assess your product and tell you exactly which directives, standards, and tests apply, with a clear timeline and next steps.

Most SME electronics reach compliance in 7–10 weeks. We confirm timing upfront so there are no surprises or delays.

No. We work with a network of accredited testing labs and handle lab selection, booking, and communication for you.Thanks to our partnerships, clients benefit from preferred pricing and priority testing slots, reducing both cost and lead time.

Often, yes. We run a gap analysis to reuse what’s valid and only test what’s missing, saving time and cost.

Yes. We review or draft product manuals, compile the Technical File (usually in 48–72h once inputs are ready), and prepare the Declaration of Conformity.