A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 9th Year of Publication
Page 01

Cover Story

CE Marking of Medical Devices

- Dr. SN Pal,Director(Technical & Operations), Hindustan Latex Ltd.

WHAT IS CE MARKING ?

  • "CE" marking is the Symbol

  • CE is the abbreviation of "Conformité Européene" meaning "European Conformity"

  • Implies manufacturer’s declaration of conformance of essential requirements with all European directives

  • Is a "Passport to Europe"

  • Is a "Symbol of Quality."

  • Is not a product quality standard

NEED FOR CE MARKING

  • Required to export to 15 European Union(EU) and 3 EFTA member states for 23 groups of products.

  • CE mark ensures that product placed on the EU market are safe as they follow the laws, regulations and administrative provisions as per directive requirement.

  • CE Marking is a measure that the EU has adopted to establish single market and foster economic development for the member states 

  • Indicates that the product may be legally placed on the market in EU countries.

  • Ensures the free movement of the product within the EU single market

NOTIFIED BODY

  • Is a certification organization which the national authority (The Competent Authority) of a member state designates to carry out the conformity assessment procedures.

E.g.: SGS, National Quality Assurance Ltd, Lloyd’s Register Quality Assurance Ltd, Bureau Veritas Quality International Ltd.

THE PROCESS OF CE MARKING FOR MD’S

  • Determine whether the product is within the scope of the directive

  • Identify the device classification

  • Select a notified body based on classification

  • Notified body to confirm the classification

In case of disagreement on classification decision to be obtained from Competent Authority/ EC commission

  • Select the conformity assessment routes

  • Compliance to essential requirements of the directive

  • Preparation of technical file

  • EC declaration of Conformity

  • Assessment of compliance of requirements by Notified body

  • Issue of certification

  • CE marking

CONFORMITY ASSESSMENT ROUTE - CLASS I MD

Back | Back To Top | Next