Regulatory Requirements and Guidelines on the Application of CE Marking

The Medical Devices Directive (MDD) 1 and the obligation to affix the CE marking apply to medical devices and medical accessories. According to Article 1 of the MDD

• A medical device refers to any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
• Diagnosis, prevention, monitoring, treatment or alleviation of disease;
• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
• Investigation, replacement or modification of the anatomy or of a physiological process;
• Control of conception; and,
• Which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
• An accessory is an article which, whilst not being a device, is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.

CE Marking is a complex area, but ies can make it easy for you.

We offer a comprehensive service to guide your company through the process of CE Testing, CE Approval, CE Certification and CE Marking.
Many products, production tools and equipment in the European market must be CE marked. CE Marking is a requirement of European legislation and a sign that the equipment or product meets appropriate standards.At ies, we can offer a CE Marking service for equipment or products. We can fulfil compliance and CE Testing requirements to enable self-declaration, either at our facility or at the manufacturing or end-user facility. Notified
body requirements can also be catered for. Additionally we can advise and assist in the preparation of the Technical Construction File (TCF).

Who needs the CE Mark and CE certification? A primer for medical manufacturer

Europe is easier to access than ever before. Still, many North American device manufacturers exporters, especially small and medium sized enterprises, avoid it because the regulatory requirements for entry seem too complicated or expensive. North American manufacturers who have successfully accessed the European market know that taking the time to understand the European system is worth the effort. The European Union has a population of 490 million people, about the same as all of North America.
The European Union now includes 27 countries. Three additional countries (Iceland, Liechtenstein and Norway) are not EU members but are included in the European Economic Area (EEA). Switzerland is not part of the European Union.
For the exporter, Europe's regulatory requirements are easier to meet than even before. Before the creation of the European Union, each country imposed its own regulations. Different standards and regulatory procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of 27 European countries into a European Union, and the resulting unification of laws, standards, and procedures, changed all that.

What are the advantage of certification?

· Customer fulfilment and opening new markets
· Improved customer retention
· Revealing operational optimisation
· Clear structures, improved flow of information
· Continuous improvements and more profitability through less disturbances
· Staff motivation Economic success

What are the ISO standards referred to by PC manufacturers?

ISO is short for International Standards Organization. Founded in 1946, ISO is an international organization composed of national standards bodies from over 75 countries. For example, ANSI (American National Standards Institute) is a member of ISO. ISO has defined a number of important computer standards, the most significant of which is perhaps OSI (Open Systems Interconnection), a standardized architecture for designing networks. The ISO also developed standards for ensuring the quality of manufactured goods; computer manufacturers as indications of the quality of their products often cite compliance with these standards. These standards are quality models, which can be used by customers to evaluate the capability of a supplier to consistently deliver quality products and services. The ISO standards most often cited by computer manufacturers as indications of the quality of the processes are listed below

CE Mark services with ACC-APAVE

· CE mark service provider nationwide with four locations to serve you better
· All necessary electrical and EMC testing provided on-site at your facility
· Detailed examination and test reports with technical solutions to each non-conformity
· Over 100 offices in Europe to support your project long after completion.
· Working with the most knowledgeable and experienced CE Mark compliance engineers in the industry.

What are the uses of CE marking?

• As proof of the required surveillance by an accredited body, the product carries the individual CE-marking of the accredited body with a four-digit number registered in russels.
• E.G. The CE-marking of TÜV Saarland carries the number 0034.

Who will certify?

The European regulations have made the procedure of compliance simple, by allowing the manufacturers to draw up the “Manufacturer’s Declaration of Conformity”, after making a risk assessment, getting the products inspected and tested to European Harmonized Standards and compiling the technical construction file. Therefore, in most of the cases there is no involvement of a certification or third party agency.

What is the procedure?

The products should conform to European Product Directives/ Standards. The certification process involves application of relevant Directives/ Standards, product testing and preparing the Technical Construction File(TCF).
If you think your product may fall in any of the above mentioned 23 categories, contact us immediately. We will provide end-to-end solutions in CE Marking your product, including consultancy, product testing and certification.

Where the CE marking should be affixed?

The CE marking should be affixed in a limited form on the packaging of the products and in full detail on the commercial documents (such as technical specs). It is not necessary to affix the CE marking on delivery notes or invoices. It is agreed not to put the CE marking directly on the products. See also the guidance paper on CE marking edited by CEN TC134.

CE Marking and the Pressure Equipment Directives

There are CE Marking directives related to pressure systems that may also be applicable to your machinery: the Pressure Equipment Directive and the Simple Pressure Vessel Directive. TÜV provides Notified Body services for the Pressure Equipment Directives through its parent company Group TÜV Süddeutschland Bau und Betrieb GmbH.
The Pressure Equipment Directive is probably the most applicable to industrial machines and processing equipment, and yet most manufacturers are unaware of its impact and requirements. It became a mandatory requirement for equipment entering the European Union on May 29th, 2002. If the machinery you produce contains gas or liquid systems operating above 0.5 bar (approximately 7.25 psi) you should investigate the application of this directive. It is likely that many of the components encompassed within your equipment will not require any rigorous assessment, but there will be a few components that may require the involvement of a Notified Body.

CE marking and the reality of SMEs

The CE marking of unique and made to measure products of low value (i.e. less than 50.000 euros) is uneconomic and does not contribute to consumer safety since the unique products are ordered on an already existing trust basis of proximity and personal contact. Thus the CE marking of these unique, made to measure products should not be compulsory, declaration of conformity by the manufacturer should suffice.
Simplified procedures for CE marking for small series production should be guaranteed through the accreditation and conformity assessment systems established under EU legislation. Public procurement should operate under these SME friendly rules.
The balanced representation of SME collective organizations in standardization technical committees and their right to vote in technical committees should be guaranteed by European Legislation on the standardization system.
Simplicity of standards written with the "Think Small First" principle should also be established in the European Legislation on the standardization system. Simplification manuals and training of SME standardization experts should be provided through European and National coordinated actions with sufficient funding

How should the marking look?

The three elements as set out above should be presented in sequence from left to right. The colours are not specified but the marking must be visible, legible and indelible. The intials "CE" will always be present at the beginning of the marking. The presence of the other elements will depend on the circumstances. If one or more notified bodies have been involved in any part of the compliance process then their respective number(s) must follow the "CE". The notified body number(s) must always have four digits even where the leading digits are "0". If a finished product includes a module bearing one notified body number and the finished product is assessed by a different notified body then both numbers must appear on the finished product after the "CE". Similarly, if one notified body assesses health & safety compliance and a different notified body assesses spectrum compliance, both numbers must appear on the finished product. A further example might be where another applicable directive (such as the toys directive) has involved notified body assessment and a different notified body is consulted for the R&TTE directive. After the notified body number(s) or directly after the "CE" if no notified body is involved comes the "alert symbol" (also called the "alert sign" or "alert mark") for equipment in Class 2 – no further marking is required for equipment in Class 1.

CE-Marking Complain Process

1.General Statement and aim of the EBCP CE Product complaint support activity.
2. Clarification as to the role, limits, and assistance of EBCP in individual cases.
3. CE medical device regulations, policy and guidelines
4. EBCP documentation and an information system for accidents, product failure, safety problems, and related reports.
5. Websites and Links: useful EMC/safety information.

How Does CE Marking Works?

The good news is that CE marking is integral part of the BS EN Standards for aggregates, and therefore, as you are likely to produce your aggregate to such standards already, obtaining the CE mark may be easier than you think.
The requirements for the CE marking are usually set in Annex ZA of your relevant BS EN Standard (e.g. BS EN 13043 aggregates for asphalt, and BS EN 13242 aggregates for unbound applications etc.). There you will find:

• The list of product characteristics you will need to designate or declare a category or value for, as appropriate (e.g. designation d/D for aggregates size, category for resistance to fragmentation, declared value of chloride content etc.)
• Whether or not a third party certification is required.
• The procedures to attest conformity of your aggregates (e.g. initial type testing, factory production control)
• Supplementary information you need to provide in the declaration of conformity
• Some examples of CE marking you could affix on the label, packaging and/or commercial documents accompanying your product.

Is there a relation between CE Marking and ISO 9000?

Companies that have a quality management certificate in their possession demonstrate with this that they have an efficient organizational form and that they have low failure costs. Failure costs are the costs incurred due to organizational shortcomings within the company. The quality system makes no reference to the quality of the product. The quality certificate is only a recommendation for customers that their oder will be processed correctly and on time. In contrast to the quality system, the CE marking only indicates that the product complies with the essential requirements relating to safety, health, environment and consumer protection of the user.
Some directives explicity make use of a quality management system (ISO 9000) as part of the conformity assessment. Only in specific cases this is a requirement to comply with CE marking directives.
If a company wishes to provide the customer with assurance about the functional quality of the product, the company needs to obtain a voluntary quality inspection mark. The inspection mark guarantees that products will conform to safety and functional requirements over the long term. It is sometimes also the case that these products meet the essential requirements of European Directives. In such cases, little extra effort is required to meet CE marking requirements.

What are the benefits of product testing and certification?

Market access:
Break into new markets with appropriate certification and compliant products
Market development:
Maximize the potential of existing markets and break into new markets
Speed to market:
For time critical industries, product testing and certification can speed the entry to market
Risk management:
Mitigate the risks and liabilities in your chosen markets and achieve secure and robust decision making through the management of risk and compliance
Product differentiation:
Through independent testing and certification your products will stand out from your competitors
Managed compliance:
In partnership with our clients we offer guidance throughout the design and manufacturing process - improving our client's time to market.
Competitive edge:
Through our distinguished product certification mark - Kitemark, trusted by 88% of the UK adult population and recognized around the world.
Customer confidence:
Through BSI's globally acknowledged and trusted independence and reputation achieve consumer and business reassurance

Are You Losing Money Because You Don’t Know How CE Marking Certification Works?

Do you really understand CE marking certification? Do you know which European directives and standards apply to your products? Do you know how to dramatically increase your product’s CE approval success rate? Will your CE marking strategy and tactics be different, if you fully understand the underlying CE marking principles?If you don’t understand the principles of CE marking, you are inclined to rely on what suppliers or customers tells you. You want to trust that the certification route proposed by a third party test and certification body is in your best interest. But are you sure there isn't a faster or more cost effective solution? Do you feel you are driving your company’s CE marking project? Or do you feel you are taken for a ride?
Here is your opportunity to take control over your company’s CE marking projects. To get back in the driver seat, so to speak. You can learn exactly how the CE marking requirements affect your company’s products and business. You can take the strategies and tactics and use them to reduce CE certification costs and get results amazingly fast.

Why is CE Marking called the "Passport to Europe" for non-EU products?

The European Union's 'New Approach directives' are mandatory on all member countries to enact through national legislation.
This legislation requires manufacturers to display CE Marking on their product, packaging and accompanying literature. Where a new approach directive is in force, it is (with few exceptions) an offence to place a product on the market without CE Marking. The manufacturer is legally responsible for ensuring that the product confirms to the requirements of the directive and for applying CE Marking.
CE Marking is one important measure that the EU has adopted to establish the single market and foster economic development for the member states. The objective of the directives is to simplify the movement of goods into and within the EU. This may eventually lead to the free movement of goods throughout Europe as more and more european countries are expected to join the EU. The European Commission thus refers to the CE Marking as a "Passport" which allows products to be freely circulated within the EU single market.
Often, consumers will consider CE Marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of safety which other products may lack. CE Marking is thus for many consumers a "Symbol of Safety." Being a manufacturer exporting to EU, if you have not got your products fixed with CE Marking, it is now time to invest in it. A CE Marking on your product will be more valuable than millions of dollars spent on TV advertising. Nowadays, it is not unusual to see some high-quality, even known brand, products have to appear in Second-hand Stores (which sells used products) or on street-vendor's Stands. Why? lack CE Marking!

What are the General principles of the CE marking?

• The CE marking shall be affixed only by the manufacturer or his authorised representative.
• The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.
• By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
• The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.
• The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
• Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.

CE Marking is not only a legal obligation

When correctly completed it is a most useful marketing tool. It will probably be the best money you ever spend on marketing in terms of maximum reward for minimum investment.

What is CE Marking ?

To compete in today's global marketplace, manufacturers are beginning to export more goods to Europe. Before doing so, however, many companies must obtain CE marking, which allows them to move their products freely throughout the European Economic Area. CE marking is required on products that fall within the scope of any of the European Union's New Approach Directives.

Why struggle with the complexity of CE Marking requirements?

Barclay Phelps have the experience of thousands of successfully completed cases of CE Marking and CE Certification. We fully understand the complexity of CE Compliance and CE Approval and we are exceptionally well qualified in this field. So why struggle with the complexity of this subject when we can do it all for you for a very modest fee.

What it means to have CE Mark?

When the CE Mark is affixed, it means that the products conform to EMC(Electromagnetic Compatibility) Directive and other relevant Directives that are relevant to the products. Many electrical appliances also have to conform to Low Voltage Directive. Electrical toys will have to conform to Toy Safety Directive.
The EC declaration of conformity must include components like :

a) Description of the products.
b) A reference to the specifications under which conformity is declared.

The reference to the specifications does not necessarily mean that you have to test these specifications. Three scenarios are apparent.

i) The product intrinsically meets the requirements of the Directive and does not need testing

. Most electronic products are not able to follow this option.
ii) Declaration is make on existing test results. If the products already conform to existing standards such as FCC for emissions and IEC 801 for immunity, then you may be confident that the product will meet the appropriate harmonized standards without further testing.
iii) Test fully to the harmonized standards or choose the technical file route. For complex and new products, this will be costly but is essential.
c) Signatory to bind the manufacturer or his representative.
d) where necessary, reference to the EC type examination certificate for radio transmitters.

Five Levels of Certification

· Level I Graduate degree in Library or Information Science from an Institute of Higher Education Accredited by the American Library Association
· Level II A Bachelor's Degree from an Accredited College or University, AND 15 Semester Hours or 20 Quarter Hours in Library Education from an Accredited College or University, AND 40 CE Contact Hour Credits - OR - A minimum of a Minor in Library Science from an Accredited College or University
· Level III A Bachelor's Degree from an Accredited College or University AND 40 CE Contract Hour Credits - OR - An Associate degree from an Accredited College or University, AND 5 years of library work within the last 10 years, AND 40 CE Contact Hour Credits
· Level IV High School Diploma or G.E.D., AND 60 Semster Hours or 90 Quarter Hours of College Credit, AND 40 CE Contact Hour Credits - OR - High School Diploma or G.E.D., AND 5 Years of Library Work within the last 10 years, AND 40 CE Contact Hour Credits
· Level V High School Diploma or G.E.D., AND 2 Years of Library Work within the last 5 years, AND 40 CE Contact Hour Credits