How to Use ISO 13485 Standard For CE Marking Approval of Medical Devices

If the medical device is manufactured outside of the European Union, the CE marking provides access to European markets for products. Before putting the product on the market in the European Economic Area, the manufacturer shall be required to get and display the CE mark on the product (EEA). This responsibility shifts to the importer if the medical device is brought in from outside the EEA. The abbreviation “CE” stands for “European Conformity,” which is the English translation of the French word “Conformité Européene. 

Since ISO 13485 is in line with European medical device directives, putting it into practise aids in meeting their requirements. As a CE mark medical device consultant , we provide guidance to medical device manufacturer for the proper and valid ISO13485 standard certification. 

Important steps for getting CE marking on your Medical Device:  

Getting the CE marking on your device involves some logical and formal procedures. The “old technique” demanded that incredibly stringent technical requirements be met. The following steps will be useful as you move through the “new way,” which includes more fair and standard requirements for safety and functionality: 

1.  Identify medical device status: 
2. Recognize regulatory requirements and their fulfil-ment:
3. Development and preservation of the technical files: 
4. Review for product conformity: 
5. Declaration of conformity: 

As medical device regulatory consultant we assured that, Companies operating outside of the European market that already have a Quality Management System based on ISO 13485 standard can more easily obtain the CE mark for their products because the ISO 13485 standard already satisfies many of the directives’ requirements for conformity assessment evaluation. In some instances, a manufacturer’s certificate of declaration of conformity is sufficient to get a CE mark for medical devices produced using ISO 13485-compliant systems.  

Read More  -  ISO 13485 Standard For CE Marking Approval

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