The European Commission describes the CE Marking as the “Passport to Europe” which allows manufacturers to freely circulate their products within the European market. The CE Marking Directive specifies the manner in which the CE Marking is to be used.
Despite some assumptions, the marking is not a symbol of quality, but rather of safety. The European Union sets minimum requirements to industrially manufactured products for ensuring the necessary level of protection with respect to safety, health, and environment. The CE Marking is mandatory for a wide range of products for human use.
The letters CE are an abbreviation of the French term “Conformite Europeen”. They indicate that the manufacturer is compliant with all applicable legal requirements of the EU “New Approach Directives” and European Regulations. All directives or regulations either adopted or under consideration, require certain products to obtain the CE Marking. Several examples include medical devices, in-vitro diagnostic devices, toys and personal protective equipment.
Since the CE Marking is a European mark under European law, it is aimed at European entities only, all non-EU manufacturers must appoint a European Authorized Representative (E.A.R.) in order to obtain the marking and introduce their product in Europe. An E.A.R. is a natural or legal person established within the European community, who is appointed by the manufacturer through a legal mandate to act on its behalf. The E.A.R. may be addressed by authorities and bodies in the community instead of the manufacturer with regards to the latter obligations under European regulation.
While the CE Marking process may appear complicated or overwhelming, it can be more easily understood once looked at as a step-by-step process.
Step 1: Classification of Products
The classification of a product is the sole and entire responsibility of the manufacturer. One of the two most important elements in the classification of a product are:
- The “Claimed intended use” – what does the manufacturer claim the product is intended to do?
- The “Mode of Operation” – how is the product fulfilling its intended purpose?
To classify a product, the manufacture must define the characteristics of the product, declare its intended use and determine whether the product is covered by which New Approach Directive, horizontally or vertically ( Horizontal Directive – applies to a group of products; Vertical Directive – applies to a single group of products).
Based on the classification, the manufacture will evaluate which directives are applicable on his product. In principle all directives are applicable unless it is stated in a directive that a product is excluded.
There may also be “internal” classifications within a specific Directive such as within the Medical Device Directive 93/42/EEC, the product could be Class I, Class IIa, IIb ,Class III or even considered as Custom Made, In-vitro Diagnostic, Active Implantable or a combination of these when introduced to the market as a Kit (“Procedure Packs” or “Systems”);
Step 2: Identification
There are several parts to the identification process. First the manufacturer must identify the Essential Safety & Health Requirements (E.S. & H.R.). It is necessary to identify conformity assessment procedures, find European Harmonized Standards and ensure product compliance.
At this point is it advisable to appoint a European Authorized Representative.
It is also necessary to determine if a Notified Body is required and if Notification to the Authorities is required. This will all depend on the classification of the product which will dictate the conformity route to be chosen, including all requirements to be fulfilled.
Step 3: Technical Documentation: Ensuring Product Compliance
After completing the classification and identification, it is time to execute the plan and prepare all of the technical documentation which will serve as evidence of the products’ conformity with the identified requirements. This includes but is not limited to safety tests, conformity certificates (if required), quality management systems implementations, labeling, packaging and instructions for use and last but not least a Declaration of Conformity.
The appointed representative will support the manufacturer in the compilation of all necessary technical documentation and organize them quickly and efficiently to be stored at the EU address to be specified on the device or the packaging or the instructions for use.
Step 4: Pre-Market Notification
The Pre-Market Notification is the official announcement that a product is about to enter the European market or is being put into service in a specific EU country. If required by a Directive, it is one of the essential requirements of the Directive and as such, must be fulfilled before the CE marking may be affixed to the product.
EU member states Authorities do not have any obligation to provide manufacturers/distributors with acknowledgement of receipt. When they eventually do so it normally happens very late in the process, or they do so simply by stating “I received”.
Any manufacturer who, under his own name, places a product on the market must inform the competent authorities of the Member State in which he has his registered place of business. This will include the address of the registered place of business and the description of the product concerned. None EU-Manufacturers, will require to ensure that their Authorized Representative completed this notification on their behalf as they themselves may not do so;
Depending on the product, it may or may not need to be notified. For example, Class I devices under the Medical Device Directive 93/42/EEC require notification, but Class IIa, IIb and Class III do not.
Step 5: Affix the CE Marking & Surveillance
After all previous steps have been completed, it is time to affix the CE marking to the product, packaging, and accompanying literature.
When the product enters the European market, it is obligatory to all manufacturers to have in place a post-marketing surveillance system as referred to in the General Product Safety Directive.
This system must be conducted either proactively or reactively and may be conducted in a variety of ways such as customer surveys, customer complaints and warranty claims, post CE market clinical trials, literature reviews, user feedback, device tracking/implant registries, user reactions during training programs, the media, experience with similar products made by the same or a different manufacturer, maintenance/service reports, retrieval studies on explants or trade-ins, in-house testing and failure analysis.
Step 6: National Requirements
In addition to the CE marking under the European legislation, there may also be national requirements under national legislations which require the manufacturer to be in conformity with.
Any Directive is required to be transposed by the national parliaments in Europe, in which process requirements may not be extracted from the Directive but requirements may be added under the national implementation of any Directive in the relevant EU state territory.
As such, there are 27 different implementations to any Directive which impose additional national requirements. The most evident example for such national requirements is connected to the 23 official languages in Europe which create the national language requirements.
After all 6 steps have been completed, the product is officially “CE marked” and compliant with the European & National requirements and as such he may freely circulate within the European market.
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