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 a higher risk the demands are therefore greater.
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 a manufacture may be able to carry out the necessary operational checks as may be necessary to demonstrate compliance with the requirements.
Intermediate design
Whereby a manufacture 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 a manufacture 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 to the ISO9001/ISO13485 series assessed by an EU approved notified body.
Stage 4
Carry out the necessary assessment of the labelling, operational, installation and maintenance documentation produced to ensure it is accurate and correct to the requirements. It must be remembered that this documentation must 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 ISO9001/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.
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 their Declaration thereby enhancing their 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.
- Independent.
- Able to verify product conformity, and assess technical files for compliance to requirements.
In certain high risk product categories it is necessary to employ an EU Notified Body to underwrite the Company administration system, 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 is displayed on the CE label on the product. In some instances, including that for medical devices, a quality system complying to 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 EN45000.
- 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/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 summarized as “a demonstrable compliance with the regulations in design, and assured consistency in production.”