To sell a medical device in the European Union (EU), it is mandatory for manufacturers to obtain or apply for CE marking for the product. CE marking ensures that the medical device is compliant with the EU regulations and can be distributed in all the 32 European countries of the region. It is the responsibility of the manufacturer to obtain the CE marking.
How to Obtain the CE Marking?
While obtaining the CE marking, manufacturers should follow the below steps:
- Identify the EU directive applicable to your device (Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC))
- Identify the classification of the medical device based on the level of risk
- Establish a Quality Management System (QMS) for your medical device
- Prepare a Technical File or Dossier Design for CE marking, demonstrating the conformity of the device
- Develop a Clinical Evaluation Report (CER) as per the MEDDEV 2.7/1 rev 4 and MDD (or MDR)
- In case of importing a medical device to the EU, a European Authorized Representative must be selected
- Unless the device belongs to Class I category, the technical file/dossier design must be reviewed by a Notified Body (NB)
- Obtain CE marking for your device from the NB along with the ISO 13485 certificates
- To demonstrate the compliance of your device with the EU directives, prepare a Document of Conformity (DoC)
To place a device successfully in the EU region manufacturers should first focus their efforts on obtaining the CE marking certification. How prepared are you for the certification? For Regulatory assistance, reach out to Freyr at firstname.lastname@example.org.