Registrations

Company & Business Registrations

From your first incorporation to a cross-border entity, pick the structure you need.

Compliance

Stay Ahead of Every Deadline

Statutory and regulatory filings we manage, tracked on one compliance calendar.

IPR

Protect What You've Built

Register, defend and manage the intellectual property that makes your business yours.

Taxation

Direct Tax, Indirect Tax & Advisory

From routine return filing to cross-border tax structuring and litigation support.

Consultation

Talk to a Specialist, Not a Ticket Queue

A short conversation with our team is the fastest way to get a clear, personalised plan.

More

Quick Links

Learn more about us or explore our presence across countries.

About India Careers Malaysia Terms & Conditions Singapore
robo-img
Hisho & Kanri
Hello! How can we help?

We provide accounting, compliance,
and advisory services.

CE Certification

Get your product market-ready for Europe, the compliant way.

CE marking is the manufacturer's declaration that a product meets the essential health, safety, and environmental requirements set out in the applicable European Union directives and regulations. It's not a quality mark or a badge of origin — it's a legal precondition for placing regulated products on the market anywhere in the European Economic Area, from machinery and electronics to toys and medical devices.

Getting it right means correctly identifying every directive that applies to your product, running the right conformity assessment route, compiling a defensible technical file, and issuing a valid EU Declaration of Conformity. Get it wrong, and you risk customs holds, forced recalls, and regulatory penalties — which is why most manufacturers bring in a certification partner rather than self-declaring blind.

Talk to a Compliance Expert Check Applicable Directives
0Products Certified
0EU Directives Covered
0Avg. Turnaround
0EEA Countries Unlocked
Directive Check
Testing
Technical File
CE Affixed
CE
EU Declaration of Conformity
CE Marking Certification
DirectiveMachinery 2006/42/EC
Assessment RouteModule A
StatusCompliant
Filed ByHisho & Kanri
Applicable Directives

Which EU directive covers your product?

CE marking isn't one certificate — it's governed by a specific directive or regulation depending on what you make. Here's the product coverage we certify against most often.

Machinery

Industrial and consumer machinery assessed under the Machinery Directive 2006/42/EC, covering guarding, controls, and residual risk.

Most Certified

Electrical & Low Voltage Equipment

Devices operating within defined voltage ranges, assessed under the Low Voltage Directive 2014/35/EU for electrical safety.

EMC & Radio Equipment

Products with radio functions or electromagnetic emissions, covered under the EMC Directive and Radio Equipment Directive (RED).

Medical Devices

Devices assessed under the Medical Device Regulation (MDR) or IVDR, typically requiring Notified Body involvement.

Personal Protective Equipment (PPE)

Safety gear categorised by risk level under the PPE Regulation (EU) 2016/425, from gloves to respiratory protection.

Toys

Children's toys assessed under the Toy Safety Directive 2009/48/EC for mechanical, chemical, and choking hazards.

Construction Products

Building materials and components assessed under the Construction Products Regulation (CPR) for structural and fire performance.

Pressure Equipment

Vessels, piping, and pressure accessories assessed under the Pressure Equipment Directive (PED) 2014/68/EU.

The Process

From product review to CE mark, in eight steps

Here's exactly what happens between telling us about your product and legally affixing the CE mark to it.

1

Identify Applicable Directives

We determine every EU directive and regulation that applies to your product based on its function, materials, and intended use.

2

Essential Requirements Review

Your product's design is checked against the essential health, safety, and environmental requirements of each directive.

3

Conformity Assessment Route

We determine whether self-certification is permitted or a Notified Body must be involved, based on product risk category.

4

Testing & Verification

Samples are tested against harmonised EN standards to demonstrate compliance with each applicable directive.

5

Technical File Compilation

Risk assessments, test reports, drawings, and manuals are compiled into a defensible technical documentation file.

6

EU Declaration of Conformity

The manufacturer's formal declaration is drawn up, citing every directive and standard the product complies with.

7

CE Mark Affixed

The CE mark is applied to the product, packaging, and documentation per the required size and placement rules.

8

Post-Market Readiness

We brief you on record-keeping, labelling, and surveillance obligations so you stay compliant after launch.

Eligibility

Who needs to CE mark their product?

Eligibility hinges on your product category and where it's sold — here's the baseline criteria that determine whether CE marking applies to you.

Product Falls Under an EU Directive

Your product must be covered by at least one of the harmonised EU directives or regulations requiring CE marking.

Sold or Placed in the EEA

Applies to any manufacturer, importer, or distributor placing the product on the market anywhere in the European Economic Area.

Any Manufacturer Location Eligible

CE marking isn't restricted to EU-based manufacturers — companies anywhere in the world can certify and affix the mark.

EU Authorised Representative

Non-EU manufacturers typically need an EU-based authorised representative or importer named on the documentation.

Compliant Technical Design

The product's design must be capable of meeting the relevant essential requirements — retrofitting compliance later is far costlier.

Registration Before Market Entry

The CE mark must be affixed and the Declaration of Conformity in place before the product is placed on the EU market.

Paperwork

Documents that make up your technical file

Compiling these correctly upfront is what makes your CE certification defensible during market surveillance checks.

Product Drawings

Design specifications and schematics

Risk Assessment

Hazard identification and mitigation report

Test Reports

Results against relevant EN standards

Bill of Materials

Component and material breakdown

User Manual

Instructions in required EU languages

Declaration of Conformity

Signed manufacturer's compliance statement

Labelling Artwork

CE mark placement and product labelling

Authorised Representative Details

EU contact, for non-EU manufacturers

Why It's Worth It

What a valid CE mark actually buys you

Beyond legal permission to sell, CE certification changes how customs, retailers, and customers treat your product across Europe.

Access to 30+ EEA Countries

One certification, free movement across the entire European Economic Area

Faster Customs Clearance

Reduces the risk of holds, inspections, or border rejections

Legal Protection

A defensible technical file shields you from liability claims

Retailer & Buyer Trust

Distributors require CE proof before listing regulated products

Recall Risk Reduction

Rigorous testing catches design flaws before they reach the market

Competitive Advantage

Certified products win tenders and contracts uncertified ones can't

Avoided Penalties

Sidesteps fines and forced withdrawal costs from non-compliance

Investor & Partner Confidence

Signals product maturity to distributors, investors, and OEM partners

After Certification

Staying compliant, shipment after shipment

Affixing the CE mark is the start, not the finish — here's what keeps your product market-legal afterward.

Technical File Retention

The technical documentation must be kept available for at least 10 years after the last unit is placed on the market.

Declaration Updates on Design Change

Any modification affecting compliance requires an updated Declaration of Conformity and, often, re-testing.

Post-Market Surveillance

Ongoing monitoring for defects, complaints, or incidents that could trigger corrective action.

Recall & Non-Conformity Handling

A documented process for withdrawing or correcting non-compliant units already in the market.

Regulation Monitoring

Tracking updates to harmonised standards and directives that may affect an already-certified product.

Authorised Representative Maintenance

Keeping your EU-based representative's details current and accessible to market-surveillance authorities.

Why Hisho & Kanri

Certification handled by people who do this daily

We've mapped enough products against machinery, EMC, medical, and PPE directives to know exactly where self-certification goes wrong — and how to get it right the first time.

Regulatory Specialists

Engineers and compliance consultants who work across EU directives every week.

Fast Turnaround

Testing and documentation coordinated without unnecessary back-and-forth.

Transparent Pricing

Clear packages with no hidden testing or Notified Body surprises.

Transparent Process

You see every test result and file update, not just a final declaration.

Dedicated Support

One point of contact from directive mapping through post-market compliance.

Secure Documentation

Your technical file and product data handled under strict confidentiality.

FAQ

Common questions about CE certification

Can't find your question here? Use the form alongside this page and we'll answer it directly.

It's the process of demonstrating that a product meets the essential health, safety, and environmental requirements of applicable EU directives, allowing the manufacturer to legally affix the CE mark.

Any product covered by a harmonised EU directive — machinery, electronics, toys, medical devices, PPE, construction products, and more — see the Categories section above.

Yes, for regulated product categories, it's a legal requirement to sell in the European Economic Area — products without it can be blocked at customs.

Not always — many low-risk products allow manufacturer self-declaration, while higher-risk categories like medical devices typically require third-party assessment.

Typically around 10 working days for straightforward products once testing is complete, though Notified Body routes can take longer.

Drawings, risk assessments, test reports, and the Declaration of Conformity form the core set — see the Documents section above for the full list.

Yes, manufacturers anywhere in the world can certify, though most need an authorised representative or importer based within the EU.

There's no fixed expiry, but the Declaration of Conformity must be updated whenever the product design or applicable standards change.

Non-compliant products risk customs rejection, forced market withdrawal, fines, and reputational damage — we help identify and fix gaps before that happens.

Because we map directives daily across dozens of product categories, keep you informed at every testing stage, and stay on for post-market compliance long after the CE mark is affixed.