CE marking.pptx
- 1. By: AARTIVATSA MPHARMA (DRA),2ND SEM 22390805
- 2. TABLEOF CONTENT: Introduction CE Mark Classification of Medical Device Why CE Marking is required? How DoYou Benefit from CE Marking? CE Marking Directives. Affixation of the MarkingToYour Product. HowTo Get Certified? Technical Documentation Declaration of Conformity
- 3. Introduction: CE Marking is the symbol .The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity".The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is a legal requirement to place a device on the market in the EU
- 4. CE MARK: The CE marking shall consist of the initials ‘CE’ taking the following form: The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5mm.
- 5. Classification of Medical Device: There are four types of Medical Device in EU: 1. Non-invasive Device 2. Invasive Device 3. Active Device 4. Special Rules
- 6. WhyCE marking is required? It is passport for product to enter EUROPE market. Implies conformance with all European Directives InspectionAuthorities Preempts all other marks for same requirements Not a quality mark! Measurement Affixing Labeling Consumer will consider CE marking On Product as an indication of conformance to laid down minimum standards.
- 7. How DoYou Benefit from CE Marking? The CE Marking allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EMA). The great benefit for manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and 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.
- 8. Other than then legal requirements to doso, benefits ofCEmarking include: Products can be compared across borders (harmonized product and test standards). Testing independently undertaken by accredited third party. Some of the testing goes beyond traditional national requirements. Product standards introduced to some countries where none previously existed. Manufacturer's responsibility clearly defined.
- 9. CE Marking Directives: Directives Title of Directives 2006/95/EC LowVoltage 87/404/EEC Simple PressureVessels 88/378/EE Safety of toys 89/106/EEC Construction products 2004/108/EC ElectromagneticCompatibility (EMC) 2006/42/EC Machinery 89/686/EEC Personal Protective equipment (PPE) 90/384/EEC Non- automatic weighing instruments 90/385/EEC Active implantable medical devices 90/396/EEC Appliances burning gaseous fuels
- 10. CE Marking Directives: Directives Title of Directive 92/42/EEC Efficiency requirements for new hot- water boilers fired with liquid or gaseous fuels 93/15/EEC Explosives for civil uses 93/42/EEC Medical Devices 94/9/EC Equipment explosive atmospheres (ATEX) 94/25/EC Recreational craft 95/16/EC Lifts 97/23/EC Pressure Equipment 98/79/EC In vitro diagnostic medical devices 1999/5/EC Radio Equipment and TelecommunicationsTerminal Equipment 2000/9/EC Cable installations designed to carry persons 2004/22/EC Measuring instruments
- 11. Affixation of the Marking ToYour Product: The CE Marking must be affixed by the manufacture after completion of the requirements of the relevant directive/s. CE marking must be affixed according to its legal format visibly, legibly and indelibly. If a Notified Body was involved in the production control phase, its identification number must also be displayed.
- 12. HowToGet Certified? Identify the EU requirements for your product Check whether your product meets the specific requirements Check whether your product must be tested by a Notified Body. TestYour Product. Compile the technical dossier. Affix the CE Marking and draft a declaration of conformity.
- 14. Technical Documentation: The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.
- 15. How to draw up technical documentation: The technical documentation should include at least: • your name and address, or those of any authorized representatives • a brief description of the product • identification of the product, for example, the product's serial number • the name(s) and address(es) of the facilities involved in the design and manufacture of the product • the name and address of any notified body involved in assessing the conformity of the product • a statement of the conformity assessment procedure that has been followed • the EU declaration of conformity • label and instructions of use • a statement of relevant regulations to which the product complies • identification of technical standards with which compliance is claimed • list of parts • test results
- 16. Declaration of Conformity: An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law.
- 17. How to draw up a declaration of conformity: As a manufacturer, it is your responsibility to draw up the EU declaration of conformity (DoC). It should contain the following information: your name and full business address or that of your authorised representative the product's serial number, model or type identification a statement, stating you take full responsibility means of identification of product allowing traceability – this can include an image the details of the notified body which carried out the conformity assessment procedure (if applicable) the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance your name and signature the date the declaration was issued supplementary information (if applicable) For imported products, the importer must ensure that the product is accompanied by the DoC and must keep a copy of it for 10 years after the product has been placed on the market. You must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.