Process of CE Marking

CE Mark Compliance Process:

The process a company has to follow to show that a product meets the essential requirements is known as attestation. The route to attestation varies with the safety of the product class. For those with higher risk, the demands are therefore greater.

Where do we start?

STAGE 1

The first consideration is to determine if the product is covered by any of the European Directives which require products to be “CE” marked and if so which ones are applicable.

STAGE 2

Having identified the relevant directives it is important to determine the European product standards and norms applicable to the manufacture and safety requirements of the product under assessment.

STAGE 3

Carry out a risk assessment to identify which of the following three categories would apply to the product in question.

Simple design whereby the manufacturer may be able to carry out the necessary operational checks as may be necessary to demonstrate compliance with the requirements.

Intermediate design whereby the manufacturer may need to employ a competent body to carry out the necessary operational checks as may be necessary to demonstrate compliance with the requirements.

High-Risk Design whereby the manufacturer must employ a competent body to carry out the necessary operational checks necessary to demonstrate compliance with the requirements. In many instances, this will need the support of a quality assurance system for the ISO 9001 or ISO13485 series assessed by an EU-approved notified body.

STAGE 4

Carry out the necessary assessment of the labelling, operational, installation and maintenance documentation to ensure it is accurate and correct to the requirements. It is required to have this documentation in the local language of the intended user.

STAGE 5

The production of a technical File

Each product or family of products requires a technical file containing all relevant technical and user information, risk assessments and manufacturing details. Each technical file will support the Declarations of Conformity. If the technical file changes so may the Declarations of Conformity.

STAGE 6

Produce a declaration of conformity identifying the product with its technical documentation and the relevant EU standards and norms applicable and with which the equipment complies. When a competent or notified body has been employed, the Declaration of Conformity will also carry the name of the Competent body and reference to the test report of the relevant checks and inspections.

STAGE 7

The implementation, if necessary, of a Quality system to the ISO 9001, ISO13485 series. This may need underwriting by a Notified Body acceptable to the EU national Government.

STAGE 8

Upon a successful assessment of the product by the selected Competent Body and when a required quality system has been assessed by the selected Notified Body, the “CE” mark may be applied and the product can then be shipped throughout the EU without restriction. When the product is supported by a quality system assessed by a notified body, the “CE” mark will be suffixed with the unique reference number of the Notified Body.

STAGE 9

Implement a customer feedback system to identify product weaknesses that may affect Health and safety and ensure there are systems in place to review product designs to reduce the recurrence of any failures. In some instances, particularly medical devices, the system will need to report back to the nominated Government Authority and keep them advised of problems encountered.

Competent Bodies

The surest method to satisfy any third party that the product is compliant with the directives and any associated standards is to employ a Competent Body, approved by one of the UK government agencies, to carry out product testing. This is mandatory for certain products including most medical devices, non-automatic weighing machines, gas appliances and some telecommunication equipment. When a Competent Body is employed, the manufacturer may include its name on its Declaration thereby enhancing its product’s legitimacy. Competent Bodies can also assess technical files.

A Competent body is usually based in a member country of the European Union and approved by an EU member. Assessed and registered to the local requirements within the EU. (In the UK this usually means approved by UKAS). Compliant with the requirements of the Test Specifications to which they must operate independently. Able to verify product conformity, and assess technical files for compliance with requirements.

Notified Bodies

In certain high-risk product categories, it is necessary to employ an EU Notified Body to underwrite the Company administration system and technical files and confirm that the required testing has been completed satisfactorily by an approved test house.

A unique certification number would be issued and displayed on the CE label on the product. In some instances, including that for medical devices, a quality system complying with ISO 9001 is often mandatory (ISO13485 for medical devices). A Notified Body must be based in a member country of the European Union and approved by an EU member, Notified to the EU Commission, Compliant with the requirements of ISO 17065 and/or ISO 17020, Independent, Able to verify product conformity, sometimes in conjunction with a Competent body, and Quality Assurance certification.

In summary

CE Marking is a legal requirement for a growing number of products. For most high-risk products the ISO9001 and ISO13485 option underwritten by a Notified Body is the most efficient and cost-effective approach in the long term. Subsequent product variants are legally supported without the need to always prototype subsequent modifications.

The broad principle can be summarised as “a demonstrable compliance with the regulations in design, and assured consistency in production.”

Introduction to Risk Management and CE Marking One of the techniques growing in importance in meeting the CE marking requirements is Risk Management including the steps of Risk Analysis and Risk Assessment. A defined process of assessing and managing risk throughout all stages of the life of a product is an important part of determining whether it is safe, and remains safe, to operate. A Technical File is expected to contain details of the Risk Management undertaken.

Risk Assessment for Machinery – EN 1050:1996 EN 1050 should be used as a basis for any risk assessment of Machinery and ATEX equipment. The standard does not specify the precise method but provides detailed guidance as to what should be considered. It covers Hazard Identification by providing a list in Annex A to the Standard. The elements to be considered in Risk Estimation are listed, and general advice is given on Risk Reduction. The Standard states that the documentation shall demonstrate the procedure and the results.

Risk Management for Medical Devices

The Risk Management Standard for Medical Devices is EN ISO 14971:2000. The Standard covers risk management throughout the life of medical devices and for each phase of that life. It includes the required content of the Risk Management File and the Annexes list of likely hazards. The standard does not provide documentation or a methodology for Risk Assessment but refers to methodologies such as FMEA. Atlantic Bridge can provide suitable methods to conduct Risk Management to EN ISO 14971:2000.

We specialize in the certification of construction products like steel tubes, and pipes as per EN 10219, EN 10255, EN 10210 and many others, we have experience auditors to assist you in the certification of laminates, cement, steel bars, angles including fences, and fabrication standards like EN 1020.

We can assist in the certification of products for pressure equipment directive (PED), low voltage directive (LVD), Electromagnetic compatibility (EMC), and Machinery directive.

We at ECAS Certifications provide various Product certifications and CE Marking as well.