CE Marking for Medical Devices, CE Mark, requirements, certification, approval, testing, European directives and standards
If you are looking for CE Marking Certification for Medical Devices, If you want to sell your medical device/Products in European countries you will need a CE Marking Certificate on the Medical products to show it complies with European health, safety & environmental protection legislation. If you’re looking for a CE Mark Consultants to help you achieve a CE Certification, look no further than Eurotech.
Eurotech Certification Body provides comprehensive testing and certification services, guiding you through every step of the CE Marking process for medical devices in India.
In order for your products to be placed on the European countries, they must meet the requirements of the relevant product/Devices directives. We help you understand and meet these directives to ensure your product completes the CE Mark Certification process efficiently & successfully.
In order for your products to be placed on the European countries, they must meet the requirements of the relevant product/Devices directives. We help you understand and meet these directives to ensure your product completes the CE Mark Certification process efficiently & successfully.
Before the CE Mark may be affixed to a medical device or Medical Products & legally sold within the European Union, the manufacturer/Exporters/Suppliers must complete the following Guidelines:
- (Technical File) Prepare for Technical Documentation to show the products compliance with applicable essential requirements & conformity assessment procedures of the applicable device directive
- Register their Medical device with the appropriate Competent Authorities
- Receive a Medical device-specific CE Certificate from a Notified Body (Class I devices do not require a certificate from a Notified Body)
8 Step to Get CE Marking for Medical Devices in India:
Navigating the CE Mark Certification process does not have to be painstaking. In fact, Eurotech makes it as easy as the following steps:
1. Classify your product - Class I, IIa, IIb, and III according to the classification rules in Annex IX of the Medical Devices Directive 93/42/EEC MDD:
- Class I. Medical Devices with low risk such as external patient support products.
- Class IIa/b. Medical Devices with medium risk such as electro-medical devices.
- Class III. Medical Devices with high risk such as cardiovascular catheters.
- Some Class I and all Class IIa, IIb, and Class III Medical devices require Notified Body approval.
