By affixing the CE Marking, the manufacturer, or its representative, or the importer assures that the item meets all the essential requirements of all applicable EU directives. Neozenith offers conformity assistance with Construction Products, Containers, Cranes, Electrical Products and Components, Electromagnetic Compatibility (EMC), Lifts, Marine Equipment, Materials, Mechanical Products, Process Machines, Pressure equipment, Personal Protective Equipment (PPE), Telecom, Toys and Wood. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives. Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R, etc…can further reduce timescales and costs.
The CE Marking Process has six simple, but necessary steps to complete to enable you to CE Mark your product.
STEP 1: IDENTIFY THE APPLICABLE DIRECTIVE(S)
The first step is to identify whether your product can be CE-marked or not. Not all products are required to be CE Marked, only the products that fall within the scope of at least one of the CE Marking Directives. There are more than 20 product Directives & Regulations covering a range of products. Such products include (but are not limited to) electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices, and construction products.
STEP 2: IDENTIFY THE APPLICABLE REQUIREMENTS OF THE DIRECTIVE(S)
Each Directive has slightly different methods of demonstrating conformity. This usually depends on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ which the product has to meet.
The best way to demonstrate that these essential requirements have been met is by meeting the requirements of applicable ‘harmonized European Norms’ (Standard) known as hENs. Standards may offer a presumption of conformity to the essential requirements of the applicable Legislation. However, do not forget that the use of standards usually remains voluntary. hENs can be identified by searching the ‘official journal’ on the European Commission’s website.
STEP 3: IDENTIFY AN APPROPRIATE ROUTE TO CONFORMITY
The CE Marking process is always a self-declaration process however you may need to involve a third party. This is set out in the ‘system of attestation’ and will vary between Directive. Some products (such as invasive medical devices or fire alarm systems) may, to some extent, have a mandatory requirement for some involvement of an authorized third party.
STEP 4: ASSESSMENT OF THE PRODUCT’S CONFORMITY
When all of the requirements have been established, you need evidence that the product meets the essential requirements of the Directive(s).
This usually involves some assessment and/or testing. It will often involve ensuring that the requirements of the applicable harmonized standard(s), which were identified in Step 2, have been met.
STEP 5: COMPILE THE TECHNICAL DOCUMENTATION
Technical documentation relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development, and manufacture of the product. Technical documentation may also be known as the Technical File or Technical Construction File.
Technical documentation can be made available in any format (i.e., paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA).
STEP 6: MAKE A DECLARATION AND AFFIX THE CE MARK
When the manufacturer, importer, or authorized representative is satisfied that their product conforms to the applicable CE Marking Directives, they must complete a Declaration. Under most Directives, it is known as the EU Declaration of Conformity but other terms exist. Such as a Declaration of Incorporation for partly completed machinery and a Declaration of Performance for construction products.
Key Benefits of CE Marking Certification
Access the world’s second-largest importer (and largest exporter)
It is mandatory to understand your obligations and demonstrate compliance
Working with a Compliance Provider from project concept helps reduce project life cycle timescales and budget
Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R, ROHS, etc…can further reduce timescales and costs
Our Approach of CE Marking
One of the best ways to achieve success of a new product is to give it the best possible start, with care and attention at every stage. At Neozenith, we can assist with the entire life cycle of a product from design and development, supply and production, distribution and delivery, to retail distribution and even final dismantling or destruction.
Complying with the CE Marking is a critical issue when looking to launch your product on the global marketplace. Understanding the myriad of the regulation that affect your product in your target market is a key to success. Our assessment process begins with the understanding where product(s) is to be marketed, who will use the product, and what are your quality expectations?
The responses help us to identify the regulatory barriers, the directives, the standards, your conformity assessment route option, etc. And to develop a rationalised compliance plan for your product range with your target markets within, as well as outside, the EU.
CE Marking for Medical Devices:
Devices that are intended to be used for medical purposes are likely to be required to be CE marked under the Medical Devices Directive (93/42/EEC, as amended), however it is important to note that not everything found in a hospital or in a healthcare setting will fall within scope. Only devices or accessories of such devices that fulfil a specific definition can be CE marked.
The Directive defines a medical device as any instrument, apparatus, appliance, software, material or other article that is intended to be used for the purposes of (where appropriate) diagnosis, prevention, monitoring, treatment, alleviation or compensation of a disease, or an injury or a handicap. The Directive also covers ‘devices’ used for the investigation, replacement or modification of the anatomy or of a physiological process, and of control of conception. As with the majority of the Directives, there is also a list of exclusions, with two most prominent being the Active Implantable Medical Devices and In-Vitro Diagnostic Medical Devices Directives.
A wide range of devices are covered by the Medical Devices Directive (MDD) and naturally some of the devices are deemed to pose a higher risk than others, for example the hazards associated with surgical tools are likely to be far greater when compared to a hospital bed. Instead of having one size fits all, the Directive deals with the wide range of devices by splitting them into one of the four classes (Classes I, IIa, IIb and III).
Accessories, whilst not being a device by themselves, are intended (by its manufacturer) to be used with a device, for the device to function as intended by the manufacturer. Accessories shall be treated as a device and shall be classified in their own right separately from the device with which they are to be used.
Many of the other ‘Product Directives’ have links to the Medical Devices Directive; predominately related to exclusions. For example, devices covered by the MDD, are excluded from the Low Voltage, Electromagnetic Compatibility, Pressure Equipment (Category 1 and SEP only) Directives. The MDD also states that were a relevant hazard exists, devices which are also machines as per the Machinery Directive, shall also comply with the relevant Essential Health & Safety Requirements of the Machinery Directive. The requirement shall only be applied to the extent where they are more specific than the essential requirements set out in the MDD.
CONFORMITY PROCEDURES
The route to conformity is very much dependent upon the classification of the device. Class I devices can be self-declared, whereas any other class requires the involvement of a Notified Body. Classification is decided upon establishing the applicable rule within Annex IX of the Medical Devices Directive. From here the route to conformity is explained within Article 11 and the applicable Annex.
For Class I devices (other than custom-made or devices intended for clinical investigations), the conformity assessment procedure is set out in Annex VII and is known as the ‘EC Declaration of Conformity.’
Whilst other Product Legislation requires manufacturers to undertake a risk assessment, the Medical Devices Directive goes further and effectively requires a Risk Management System (RMS) to be implemented. The RMS not only deals with the identification of the initial hazards associated with a device, but also has the procedures for undertaking post market surveillance. Whilst the Directive does not set out a formal procedure, a harmonised European Standard (EN ISO 14971) is available to be used.
Finally, the requirement to register the company with an enforcement authority is unique to the Medical Devices Directive. In the UK, manufacturers would register themselves with the MHRA (at the cost of a small administration charge). Registration is on a per-product-code basis, not necessarily on a per-product basis. Multiple codes may apply where a manufacturer has a wide product portfolio, however, the registration form allows this to be done in a single application.
HOW WE CAN HELP YOU:
The CE Marking Association have a range of services to assist manufacturers, importers and users of Class I Medical Devices with a range of services, as well as providing advice for the Class IIa & b and Class III Devices too. Here are some of the services on offer:
In-vitro Diagnostic Medical Devices:
There is a wide range of ‘devices’ that are intended to be used in medical applications and the majority of these ‘medical devices’ will come under the Medical Devices Directive, but there are also two additional Directives that cover two specific areas; ‘In-Vitro’ and ‘Active-Implantable.’
In Vitro is Latin for in glass, which gives a good clue to as to what is in scope; effectively the In Vitro Diagnostic Medical Devices (IVDMD) Directive applies to any medical device (as defined under the Medical Devices Directive) which is intended to be used for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
– concerning a physiological or pathological state, or
– concerning a congenital abnormality, or
– to determine the safety and compatibility with potential recipients, or
– to monitor therapeutic measures
The Directive (98/79/EC, as amended), which came into force on the 7th June 2000 applies to both devices and accessories, which could be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in the combination of other devices.
CONFORMITY REQUIREMENTS
The procedure for CE marking is dependent upon the type of device and may need the involvement of a Notified Body;
Why Choose Neozenith for CE Marking Certification?
For over 5 years, we have worked successfully with Electrical and Electronic, Construction, Machinery, Medical Devices product manufacturers, importers, in India to help them better manage risk and assure regulatory compliance. The reassurance of consulting an officially recognized conformity assessment body like Neozenith is invaluable. Our staffs keep us updated for the development of international, industry, and regulatory standards worldwide, keeping you and us at the forefront of changes in the various approvals requirements and certification methods.
Together, we acknowledge your desire to create a product that is aesthetically pleasing as well as safe, reliable, high performance and efficient. Providing you with the highest levels of service is a priority for us.
