CE is a Certification Mark on the products intended for safety, health, and environment. The origin of Certification Mark is Europe. In this country, a quality regulating authority called EEA (European Economic Area) which validates the quality of their listed products. EEA is inclusive of Iceland, Norway, European country and Liechtenstein. It is deemed to the EEA single market. “CE” literally means European Conformity. At the inception, it was EC Mark, but in the year 1993, it was changed to CE Mark. CE Marking is made mandatory and the products which are exported to EEA from other countries should possess CE Marking.
CE Mark Certification
The logo has its own value of a standard. CE technical expert strives to maintain the standard of CE Marked products in order to match up with the shifting trends of different products and makes the logo more competitive. CE holds the international standard and many products are sold even outside EEA.
CE Marking ISO Certification Services
CE Marking is a standard fetched by EEA and allows the manufacturers to use the mark for the standard.
ISO Certification is an International non-governmental organization which is an independent quality management system with its own standard. Though certification is not mandatory, still it gives a minimum standard and trust for a product.
You must possess CE Marking for your product to sell medical equipment in the European Union (EU). CE Marking system shows that your medical device fulfills with the valid EU regulations and permits your product to sell in 32 European countries. The manufacturer is responsible for maintaining regulatory compliance and protecting CE marking for his product despite he outsources any or all components of his manufacturing operations.
How to get CE marking?
CE Marking is the declaration given by the manufacturer that his company’s medical device meets the appropriate regulatory equipment. To understand your requirement which is needed to meet out, you should categorize the device. It indicates the required activities to display compliance.
Before affixing CE Mark to a Medical device to legally sell the device within the European Union, the exporter or manufacturer should complete the following:
- The Technical documentation should be prepared to show the product’s conformity with essential needs and compliance assessment procedure of the device directive.
- Register the device with the correct competent authorities
- From a notified body a device-specific CE Certificate should be received
How to get CE Marking for a Medical Device?
Getting CE Marking for a Medical device contains the following steps:
Classification: The manufacturer should carefully examine his medical device. Defining the uniqueness of the medical device is a critical and valuable step. The core essence of the step is identifying EU legislation and directives, the suggestion they may have for the medical device, ensuring all regulations are complied.
The further step is to identify all related European standards and other important health and safety requirements once the medical device is classified. This is an essential step in ensuring the medical device is complied with all the necessary standards.
In order to get CE Marking, the manufacturer should complete and gather all the necessary technical documentation. These can be inclusive of assessments, medical device tests, relevant audits and product inspections. It is necessary for a manufacturer to issue a Declaration of compliance.
All the medical devices need a Technical file before awarded to CE Marking. The technical file will be considered as a proof of conformity with relevant directives. The technical file copy should be kept inside the EU at all times to produce in front of any EU Competent Authorities if required.
Appointing a European authorized representative (EAR):
EU Medical Device Directive says that a manufacturer should compulsorily designate an authorized representative in the European Union unless he does not have a registered address in EU. In such a case, he may not make his product available in the EU Market. So, it says all manufacturers who are located outside EU seeking CE marking for their medical equipment should appoint an E.A.R
The manufacturer shall be able to self-clarify the medical device when his medical equipment falls in the first class product category. The manufacturer has to work out with a Notified body for the class I products and for the same the Notified body needs to conduct a technical documentation audit.
Affixing the CE Marking
Soon after the medical device is certified the manufacturer is ready to affix the CE Mark. The CE Marking should be affixed on both the package and device on the medical device in a clear manner along with the EAR details.
Complying with the National requirement is the final step. An additional registration with National Competent Authorities should be done by the manufacturer to introduce his medical device in several EU countries.