CE Marking is the process of certifying that a product meets EU safety, health, and environmental requirements. Medical devices designed, manufactured, sold, or designed to be distributed in the European economic area are required to have the CE Marking. It is the manufacturer’s declaration that the product meets the European Union’s (EU) standards for health, safety, and environmental protection.
CE Marking is a symbol of quality and this certification has been recognized throughout the world. The mark consists of the CE logo and, if applicable, the four-digit identification number of the device in the conformity assessment procedure. “CE” is an abbreviation of the French term “Conformité Européenne” which means “European Conformity.” Medical Device CE Marking certificate is provided by a notification body after a review of a technical file. The United States Food and Drug Administration (FDA) provides approval after a thorough review of the medical product. The CE Marking is needed to market Medical Devices and related products in any part of the European economic area, irrespective of its country of origin.
As per Medical Devices Directive (MDD), medical devices are classified into four classes. This classification is based on the level of risk. The four classes for medical devices are Class I, Class IIa, Class IIb, Class III.
Class I Medical Devices
These are considered low-risk devices compared to the other types of medical devices. Class 1 Medical Devices can be further classified into three classes.
a. Class 1 non-sterile and non-measurable medical devices: These devices are exempt from Notified Body audit and a certification is not required for non-sterile and non-measurable medical devices of Class I. Medical Devices in this category can affix the CE Mark by self-declaration of conformity and complying with other requirements.
Examples:
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b. Class 1 Sterile Devices: As per European MDD, Notified Body Audit and Certification are required for Class I (s-sterile) Devices. The CE Marking process can be completed only by complying with MDD requirements and Harmonized Standards, followed by submitting a Technical File to Notified Body and Site Audit.
c. Class 1 Measuring Devices: Like Class 1 Steril Devices, Notified Body Audit and Certification are required for Class I (m- measuring) Devices. They are also required to comply with MDD requirements and Harmonized Standards, followed by submitting Technical File to Notified body.
CE Classification may change depending on the intended use. Please check with MDD 93/42/EEC ANNEX IX for your device classification.
Class II Medical Devices
a. Class IIa Medical Devices: These devices are considered to be medium-risk devices compared to the Class-I type of Medical devices. Class IIa Medical Devices require product testing, quality system implementation (ISO 13485 Certification), technical file preparation, Notified Body audit, and certification.
Examples:
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b. Class IIb Medical Devices: This specific class of devices is considered as a high-risk device compared to Class I and Class IIa type of Medical device. Class IIb Medical Devices also requires product testing, quality system implementation (ISO 13485 Certification), technical file preparation, Notified Body audit, and certification.
Examples:
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- Blood bag
- Contact lens solution
- Condom
- Dental Implant
- Intraocular lens
CE Classification may change depending on the intended use. Please check with MDD 93/42/EEC ANNEX IX for your device classification.
Class III Medical Devices
These devices are critical devices and higher risk compared to Class IIa and Class IIb Medical Devices. Class III Medical Devices require product testing, quality system implementation (ISO 13485 Certification), Technical file preparation, Notified Body audit, and certification
Examples
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- Pacemaker
- Absorbable Suture
CE Classification may change depending on the intended use. Please check with MDD 93/42/EEC ANNEX IX for your device classification.
Liberty Management Group (LMG) has offices and associates around the globe. Our experienced consultants can coordinate activities in meeting all the requirements for CE Marking such as product testing, technical file preparation, Notified Body audit, and integrating multiple Quality Management Systems such as Medical Device GMP, ISO 9001, and ISO 13485 certification.
Our Services Include:
- Medical Device Classification
- Identification of MDD requirements
- Identification of Harmonized standards
- ISO 13485 Implementation
- Identification of Notified Body
- Technical File preparation
- Technical File submission to Notified Body
- Technical file re-submission
- Assistance with Notified Body audit
- Assistance in closing non-conformities
- Affix CE Mark
