1. What is CE Marking?
Compliance with the Medical Devices Directive guidelines is declared by placing the CE Marking on the product, and providing the device with a Conformity Declaration. The letters "CE" are the short form of French phrase "Conformité Européene" which means "European Conformity".
2. Indication of CE
The CE marking attached onto a medical device verifies that the product meets as many EC guidelines as applicable to them.
3. What is the role of ISO 13485:2003?
CE marking needs execution of Quality management system as per the Annex V & II of MDD 93/42/EEC as its amendment 2007/47/EC that is gained easily by obtaining an ISO 13485:2003 certificate as this ISO standard compiles with both the annexes of MDD 93/42/EEC as its amendment 2007/47/EC. So ISO 13485:2003 is not compulsory but is an easy method to implement the Quality management system as per the EU standards in order to get CE certificate.
4. Advantages of CE marking
The entire process of CE is very much simple and effective. CE marking is a benchmark of Quality that opens gateways for European and non European market. A manufacturer who has gained CE marking for a medical device can sell his device in non European market too by obtaining a certificate of free sales (FSC) from the health ministry of the country to which he wants to export.
5. Penalties for forging the CE marking
The procedures, sanctions and laws that apply to counterfeiting of the CE marking differ according to Member States’ national administrative, criminal and civil laws. Depending on the intensity of the crime, economic operators may be liable to a penalty or imprisonment. Products could be recalled from the market. However, if the medical device is not regarded as an impending safety risk, the manufacturer could be given a chance to bring the product into compliance with the legislation applicable rather than being forced to recall the product off the market.
6. CE marking Vs other markings
CE marking is the only marking that portrays compliance with the essential requirements of the orders that provide for its affixing. A product may bear supplementary markings provided that they do not have the same importance as the CE marking, they are not accountable to cause confusion with the CE marking and they do not impair the visibility and legibility of the CE marking.
7. Where to place CE marking?
The marking must be fixed to the product or to the product's data plate. In case that is not feasible due to the nature of the product, the CE marking must be fixed to the packaging or to any documents that accompanies with it.
8. Countries requiring CE marking
CE marking is compulsory for certain product groups in the European Economic Area (the 28 member states of the EU plus the EFTA countries Norway, Liechtenstein, Switzerland, Iceland plus Turkey). The manufacturer of products made within the EEA and the importer of goods made in other countries must ensure that CE-marked goods conform to standards.