CE MARKING AND TAPELESS

CE MARKING AND TAPELESS

Obtaining a “CE” mark means more than having the ability to sell or market one’s products within the European community.  These communities, 27 member states of the EU, Iceland, Norway, Lichtenstein, Turkey, Croatia, Macedonia, Albania, Serbia and Montenegro, require a conformity of one’s products whose purpose is to protect the safety, public health and consumer from non-conforming products.

This CE marking process is extensive and thorough.  Each manufacturer is required to compile a technical file that demonstrates approved safety and regulatory standards along with detailed manufacturing, packaging and quality control procedures.  The CE mark must be displayed on the package when used in that market, providing an assurance to the consumer that the product has met the combined conformity and standards of the member nations.

To highlight the depth to which a product must conform, an outline of the manufacturer’s responsibilities include:

1.      ensure compliance product design and manufacture

2.      caring out conformity assessments

3.      draw up the technical documents

4.      draw up the EU declaration of conformity (D of C).

5.      affix the conformity marking ( CE marking)

6.      keep the technical file and D of C

7.      ensure continued conformity by reviewing on a several year cycle

8.      take into account changes in the standards or technological specifications which are stated for their product’s compliance requirements

9.      secure the type/serial/batch numbers to the product

10.  take corrective actions or withdraw/recall the products from the market when there is a reason to assume non-conformity

11.  in such cases, inform the appropriate authorities

12.  indicate name and contact address of manufacturer on the product

13.  on request, provide information/documentation to authorities and cooperate with them

Each product must have achieved the same degree of conformity so not only has Tapeless achieved a high level of efficacy and usefulness clinically, it has achieved a high level of excellence not apparent by simply looking at the product.

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