home page
Today's date is Wednesday, October 23, 2019
Presence Blog

Brief Introduction of Directive 93/42/EEC Medical Devices


Directive 93/42/EEC Medical Devices

  1. A Medical Device is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
    • diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
    • investigation, replacement or modification of the anatomy or of a physiological process.
    • control of conception
  2. The following products are excluded from the scope of the Directive:
    • In vitro diagnostic devices
    • Active implantable devices covered by Directive 90/385/EEC
    • Medicinal products covered by Directive 65/65/EEC
    • Cosmetic products covered by Directive 76/768/EEC
    • Personal protective equipment covered by Directive 89/686/EEC
    • Tissues or cells of human origin
    • Viable tissue or cells of animal origin

Go To Top




Requirements for Affixing of the CE Marking

• Passport to Europe • What is ce marking • CE Marking Solution
• Introduction to CE Mark Certification • ISO 9001:2015 Certification in Delhi • ISO Certification in Dubai
• ISO 9001 Certification in UAE • ISO 9001 Certification in Saudi Arabia • Products Covered by CE Marking

The CE Marking must be affixed to the product, to its data plate or, where this is not possible or not warranted due to the nature of the product, to its packaging, if any, and to the accompanying documents by the manufacturer, the authorized representative in the European Community or, in exceptional cases, by those responsible for placing the product on the market.

What We Do

 

The CE Marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 18 countries of the European Economic Area (EEA).

There is only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. Various conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.


The need of CE marking

The European CE certification procedure has been mainly set up to:
  • Harmonize all varying national regulations for consumer and industrial products in European Member States, so that the Single Market is encouraged;
  • Bring about cost savings for producers;
  • Enhance the safety of products;
  • Supply public bodies with a uniform procedure that can be checked.
With the help of the conformity assessment procedures, the authorities can ascertain that the products that are placed on the market comply with the requirements as stated in the regulations of the directives. The CE marking is consequently largely for the benefit of the authorities. However, safe products are also necessary for the end user in the work or consumer environment.

Requirements for Affixing of the CE Marking

The CE Marking must be affixed to the product, to its data plate or, where this is not possible or not warranted due to the nature of the product, to its packaging, if any, and to the accompanying documents by the manufacturer, the authorized representative in the European Community or, in exceptional cases, by those responsible for placing the product on the market.


CE Mark Introduction | CE Marking Directives | ISO 9001 certification Dubai | ISO 9001 certification Saudi arabia | ISO certification Delhi | ISO 9001 certification India | ISO Certification in UAE | What is CE Marking | Products covered by CE Directive | Product Passport to Europe | CE Certification