The CE Mark indicates conformity with European health, safety and environmental standards. CE marking is mandatory for medical devices manufactured or distributed within the European Economic Area, regardless of their country of origin. CE Marking consists of a logo, and a four-digit identification number of the notified body, if they are involved in the conformity assessment process. The abbreviation of CE is “conformité européenne” which means “European Conformity” in French.
It is the medical device manufacturer’s responsibility to check that their product is in conformity with all of the legal requirements to achieve CE marking, sets up the technical file, issues the EC Declaration of Conformity, and places CE marking on a product. Distributors of medical devices are required to check the presence of both the CE marking and necessary supporting documentation.
According to Medical Devices Directive (MDD), CE Marking for medical devices are classified into four classes based on the level of risk: Class I, Class IIa, Class IIb, Class III. However, these classifications may change depending on the intended use. (Refer to MDD 93/42/EEC annex ix for device classification).
Class I Medical Devices
Class I medical devices are devices that are considered to be low-risk. As per the European MDD, CE Marking for Class I medical devices can be classified again into three different classes as follows:
A. Non-sterile and non-measurable medical devices (Class I):
- Notified Body audit is not required for Class I medical devices such as non-sterile and non-measurable medical devices. This exemption allows them to self-declare conformity if they comply with all other requirements and affix the CE Mark. The following are some examples of Class I devices:
- Dental Chair, Examination Gown, Forceps Splint, Sterilization wrap, Stocking, Reusable surgical, Mask, Patient Bed, and Arm sling.
B. Sterile Devices (Class I): Class I sterile devices are different from other Class I medical devices as they require:
- Compliance with MDD requirements and Harmonized Standards.
- Submission of technical file to the Notified Body.
- Site audit by the Notified Body required.
C. Measuring Devices (Class I): Class 1 Measuring devices are similar to Class 1 Sterile Devices as they require.
- Compliance with MDD requirements and Harmonized Standards.
- Submission of the technical file to the Notified Body.
- A site audit by the Notified Body is required.
Class II Medical Devices
Class II Medical Devices are medium risk compared to Class 1 devices. They are classified into Class IIa Medical Devices and Class IIb Medical Devices.
A. Class IIa Medical Devices:
- Require product testing
- Mandatory quality system implementation (ISO 13485 Certification)
- Submission of technical file to the Notified Body
- A site audit by the Notified Body is required
The following are some examples of Class IIa medical devices: Artificial teeth, Dentures, Massagers, ECG Machines, Patient Monitors, Soft Contact Lenses, Surgical Gloves, X-ray film
B. Class IIb Medical Devices
Class IIb Medical Devices are considered as high-risk devices compared to other Class I and Class IIa devices. They require
- Product testing
- Mandatory quality system implementation (ISO 13485 Certification),
- Submission of technical file to the Notified Body
- A site audit by the Notified Body is required.
The following are some examples of Class IIb medical devices: blood bags, contact lens solutions, condoms, dental implants, intraocular lens
Class III Medical Devices
Class III Medical Devices are critical higher-risk devices compared to Class IIa and Class IIb categories. Class III Medical Devices require:
- Product testing
- Mandatory quality system implementation (ISO 13485 Certification),
- Submission of technical file to the Notified Body
- A site audit by the Notified Body is required
The following are some examples of Class III medical devices: Pacemakers, Absorbable Sutures
How to Get CE marking for Medical Devices?
A manufacturer or distributor is allowed to affix the CE marking when they fulfill all the applicable regulations and standards.
- The intended purpose of the product: Making a precise description / defining the intended purpose of the product is the first step in the process.
- MDD Requirements: Determining the applicable CE directives and regulations applicable to the product and fulfilling those requirements.
- European harmonized standards: Identifying the applicable European harmonized standards to prove conformity with the essential requirements.
- Requirements of the European harmonized standards: Identify the specific requirements applicable to your product from the standard.
- Conformity assessment against the essential requirements: Conduct conformity assessment and document the process.
- Information required to use the product safely: Provide the user with the necessary information required to use the product safely like user manual, warning labels, instructions for use, installation, etc.
- Consistency of production: In addition to conformity with requirements, the conformity assessment check for consistency with the output of the production process.
- Compile a Technical File: Compiling a technical file is a requirement for compliance with the Medical Devices Regulation and the CE Marking process. This is a comprehensive description of your device.
- Affix the CE marking: The CE Mark can be affixed to the device after the documentation process is completed and conformity with the technical requirements is established.
- Monitor developments: It is important to continuously monitor any new rules/amendments with CE directives and regulations to maintain ongoing compliant with the product
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
