The Single Market
The objective of the European Single Market is to remove barriers to trade throughout the European Economic Area.
The European Parliament has issued Directives intended to put the Single Market into practice.
A series of Directives (‘The “New Approach Directives” ) provide a `level playing field’ for product safety requirements across the European Community. The CE mark shows that a product complies with the appropriate New Approach Directives.
The Scope of the Directives
The “New Approach” Directives cover an expanding range of products. These now include construction products used in building, electrical and electronic goods, gas appliances, machinery, medical devices, personal protective equipment, pressure equipment, lifts, toys, telecommunications and several more product lines.
Each EC directive has to be introduced in the member countries by the laws and regulations of that country.
Product assessment for CE Marking
Each Directive contains a list of Essential Requirements that the product must meet and a process to assess how the manufacturer demonstrates that the Essential Requirements are met.
The Technical File is the way a manufacturer puts together the evidence that he has met the appropriate Directive or Directives.
For products with a low risk of harm, it is common for a Directive to accept that a manufacturer can Declare Conformity with the Directive without reference to outside testing or verification agencies. For products with higher risks external testing and verification is often required. The Directives detail how a manufacturer declares conformity.
The Role of Standards
A very large number of Standards have been agreed which assist manufacturers in meeting the Essential Requirements of the Directives. A manufacturer should always check these standards or European Norms (EN), to see whether they are applicable to a particular product. However, standards are only a means to meet the Essential Requirements; the manufacturer must demonstrate how all the Essential Requirements have been met.
The Application of the CE Mark
Before a product is CE marked, it must comply with all the directives that apply to it. Once the manufacturer has made a written Declaration of Conformity with these standards the product can have the CE mark affixed to it.
Should the CE Mark be fitted to a product which does not comply with all the applicable directives, the manufacturer of the Authorized Representative in Europe can be prosecuted.
Implications for manufacturers
The purpose of the directives is not to ban any products from the European Single Market, unless the product is poorly made or is unsafe. For most reputable manufacturers, complying with the essential requirements of the directives is not particularly onerous and companies that have always taken a responsible attitude to the performance and design of their products will have few problems complying with the New Approach directives. The difficulties that arise are most often with the way a manufacturer demonstrates compliance.
Manufacturers may well find it cost effective to seek outside help in the early stages of complying with the Directives in order to save time and prevent expensive mistakes. However, it is important to be aware that it is rarely necessary to commit to an expensive program of testing and modifications. Unless the Directives which apply to the product specifically require the involvement of a third party for product approval or quality system assessment, the manufacturer can affix the mark without having to invo lve a test house.
The extent of the CE mark directives introduced within the European Union cover a wide-ranging group of products. Directives have already been issued including:
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Further Directives are being devised and existing Directives are being revised so it is important to find out what Directives apply before starting to CE Mark a product.
A list of directives can be viewed from http:ec.europa.euenterprisenewapproachlegislationdirectivestable1.htm
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 a higher risk the demands are therefore greater.
Where do we start?
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.
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.
Carry out a risk assessment to identify which of the following three categories would apply to the product in question.
Whereby a manufacture may be able to carry out the necessary operational checks as may be necessary to demonstrate compliance with the requirements.
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 ISO9001ISO13485 series assessed by an EU approved notified body.
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.
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.
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.
The implementation, if necessary, of a Quality system to the ISO9001ISO13485 series. This may need underwriting by a Notified Body acceptable to the EU national Government.
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.
Implement a customer feedback system to identify product weaknesses that may effect 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.
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.
Able to verify product conformity, sometimes in conjunction with a Competent body, and Quality Assurance certification.
CE Marking is a legal requirement for a growing number of products. For most high risk products the ISO9001ISO13485 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 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 a medical devices and for each phase of that life. It includes the required content of the Risk Management File and in the Annexes lists likely hazards. The standard does not provide documentation or a methodology for Risk Assessment but refers out to methodologies such as FMECA. Atlantic Bridge can provide suitable methods to conduct Risk Management to EN ISO 14971:2000.