Medical Device Classification Class Is

Class 1 sterile Device

Class 1 sterile Device CE marking, Notified Body involvement is mandatory. Class 1 sterile manufactures should implement ISO 13485 and certification is recommended. GMP controls are necessary.

Class I Sterile Devices must comply with all the requirements for Class I devices. Establish and maintain the relevant procedures of a Medical Device Quality Management System.

Contact a Notified Body who can audit the Quality Management System and Technical Files

More details about process of certification click here .

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