CE Marking Certification Consultants in India & Middle East

Q: Can I self-certify my product?

It depends on the directive and the risk class. For 'lower risk' products like simple electrical appliances or Category I PPE, manufacturers can often self-declare. High-risk products like medical implants or pressure vessels MUST involve a Notified Body.

Q: Does CE Marking expire?

The CE Mark itself does not expire, but the EU Declaration of Conformity needs to be kept current. If the standards change or you modify the product, you must update your Technical File and DoC.

Q: Is CE valid in the UK?

Post-Brexit, the UK introduced the UKCA Mark. While the UK government has extended recognition of CE Marking for many goods indefinitely, specific sectors like medical devices have their own transition timelines.

Unlock the European Economic Area (EEA)

Mandatory compliance for selling in 30+ countries.

CE Marking is a manufacturer's declaration that a product complies with the essential health, safety, and environmental protection requirements of the relevant European Directives.

It is not a quality mark, but a legal requirement for placing products on the market in the EU, Iceland, Liechtenstein, and Norway. Without it, your goods risk being seized by customs or banned from sale.

Whether you are manufacturing Medical Devices in India or Construction Machinery in the UAE, IQS guides you through the complex Technical File and Notified Body requirements.

Does Your Product Need CE?

If your product falls under any of these EU Directives, CE Marking is mandatory.

Low Voltage (LVD)

Electrical equipment between 50-1000V AC.

Machinery (MD)

Industrial machines, assembly lines, and safety components.

Medical Devices (MDR)

Surgical instruments, diagnostic devices, and implants (MDR 2017/745).

Construction (CPR)

Cement, steel, glass, and other permanent structural materials.

Toys Safety

Products designed for children under 14 years of age.

Pressure Equipment

Vessels, piping, and accessories under pressure (PED).

Check Your Product Category

6 Steps to CE Compliance

IQS manages the entire lifecycle of your product certification.

1. Identify Directive

Determine which EU Directives and unified standards apply to your product.

2. Verify Requirements

Check if your product meets the specific essential requirements (design, safety, etc.).

3. Route to Conformity

Determine if you can self-certify or need an EU Notified Body assessment.

4. Product Testing

Conduct lab tests (EMC, Safety, RoHS) to prove conformity to standards.

5. Technical File

Compile the Technical Construction File (TCF) containing drawings, test reports, and manuals.

6. Declaration

Draft the EU Declaration of Conformity (DoC) and affix the CE Mark.

Why Choose IQS?

EU Expertise

Our consultants deeply understand EU Directives and harmonize standards (EN).

Lab Network

We partner with accredited labs in India and UAE for cost-effective product testing.

Faster Access

We streamline the Technical File creation to reduce your time-to-market.

Authorized Rep

We can connect you with an EU Authorized Representative (EC REP) if required.

Frequently Asked Questions

It depends on the directive and the risk class. For "lower risk" products like simple electrical appliances or Category I PPE, manufacturers can often self-declare. High-risk products like medical implants or pressure vessels MUST involve a Notified Body.

The CE Mark itself does not expire, but the EU Declaration of Conformity needs to be kept current. If the standards change or you modify the product, you must update your Technical File and DoC. Notified Body certificates (e.g., for ISO 13485 or MDR) typically have a 3-5 year validity.

RoHS (Restriction of Hazardous Substances) is a specific directive (2011/65/EU) regarding materials (like lead or mercury) in electronics. CE Marking is the overarching declaration that requires RoHS compliance (along with LVD/EMC) for electrical goods.

Post-Brexit, the UK introduced the UKCA Mark. While the UK government has extended recognition of CE Marking for many goods indefinitely (check latest guidance), specific sectors like medical devices have their own transition timelines. We help with both CE and UKCA.

CE Marking Certification Consultants in UAE & Saudi Arabia