A Guide to CE Mark For Medical Devices: What, How, & Why

To secure CE mark, the manufacturer is expected to ensure all EU-wide requirements for the medical device have been complied. If the device complies with strict safety, health, and environmental protection benchmarks, it may be granted the CE mark certification. Notably, securing the CE mark for medical devices is a legal requirement under the EU MDR. 

What is the CE mark for medical devices?

Securing the CE mark for medical devices is critical for manufacturers and distributors who want to place their products in the European Economic Area (EEA). This logo demonstrates the product meets the essential requirements for health, safety, and environmental protection set by EU regulations.

Notably to comply with EU MDR, CE marking is not optional. It is a legal requirement. Having the CE mark confirms the product has successfully undergone the necessary regulatory assessments. Hence, it can be marketed across Europe without the need for additional national approvals.

Pre-audit requirements for CE mark

1. Identification of directives: Identify applicable EU directives for your device.
2. Technical document preparation: Prepare thorough technical documentation to support your CE mark application.
3. Comply with medical device labelling guidelines: Ensure proper CE mark guideline-compliant labelling of your medical device.
4. Risk assessment: Conduct a comprehensive risk assessment for your device.
5. Select a notified body: Select a reputable notified body.
6. Quality management system: Implement a thorough and robust ISO 13485-compliant quality management system (QMS).
7. Post-market surveillance requirement: Develop a thorough monitoring plan for post-market performance of the medical device after regulatory clearance.

3 Key criteria for securing the CE mark for medical devices

To secure the CE mark for medical devices, manufacturers must demonstrate compliance in these 3 areas.

1. Scientific validity: The medical device should achieve its intended purpose based on established scientific principles.
2. Analytical performance: The accuracy, sensitivity, precision, and specificity of the device are evaluated. Analytical performance tests are vital for laboratory instruments, diagnostics, and monitoring devices.
3. Clinical performance: The device should be able to deliver the intended clinical benefit when used as directed. For high-risk medical devices, clinical investigations have to be performed to obtain real-world evidences.

How to get the CE mark for medical devices?

For CE mark certification, the type of product and its specific requirements will determine the level of complexity of the regulatory process. In case of CE mark certification, manufacturer is responsible for ensuring compliance with all relevant EU-wide requirements for the medical device. Additionally, the manufacturer has to determine whether they can assess their product by themselves or whether a notified body will be required. Furthermore, a notified body will demand fees for their service. Moreover, the manufacturer will have to prepare a technical dossier demonstrating compliance.

What does the CE mark signify?

Importers and manufacturers are required to affix their medical device with the CE mark to market their product in EU. Without the CE mark, the medical device cannot be legally placed in the European market. The CE mark for medical devices signifies the medical device is:

• Fully compliant with EU medical device regulations
• Safe and effective for the intended use
• Ready to be launched within the EEA market

Time required for securing the CE mark

The CE mark certification process takes approximately four to six weeks for approval. However, the approval process can take longer, if the product needs modification or the technical documentation is not fully complete. 

Validity of CE mark

The CE marking certification for medical devices is usually valid for a period of three years. After this period, the certification has to be renewed. Notably, it is recommended to start the registration renewal process at least 6 months prior to the expiry of the certification. 

Design standards for the CE Logo

The CE mark has strict design standards. Moreover, modifying the CE logo is not permitted. We have listed the important design and size guidelines:

• The letters ‘C’ and ‘E’ have to typed using specific geometric proportions based on imperfect semi-circles.
• The arms of the letter C have to extend longer than a standard semicircle by one square unit.
• The space between the C and E has to be maintained for clarity and recognition.
• The CE logo has to be at least 5 mm in height
• The logo maybe scaled up. However, the proportions must not be distorted
• The logo cannot be stylized, combined with other symbols, or partially obscured

Where should the CE mark be placed?

The CE logo must be visible to the user and authorities. Additionally, it should be legible and easily identifiable. Also, the logo should be indelibly affixed so that it cannot be removed or tampered with. Notably, if direct marking on the device is not technically possible or appropriate owing to size or material limitations, alternate placement is allowed. However, the placement of the logo must still comply with Article 20 of MDR. The acceptable locations are as follows:

• Directly on the product (preferred)
• On the data plate or nameplate
• On the outer packaging
• In accompanying documents like user manuals or instructions for use (IFU)

Why does CE mark for medical devices matter?

Although it is a legal requirement, the CE marking provides a number of advantages for medical device companies.

• Market access to all EU/EEA countries
• Demonstrates commitment to regulatory guidelines, thereby providing a competitive edge.
• Reduced trade barriers through harmonized standards
• Improved credibility and builds trust with regulators, partners, and end-users

Common mistakes to avoid while using CE marking

Notably, medical devices with an incorrect or missing CE logo may be banned from entering the EU market. Penalties or recalls may be imposed and distribution maybe blocked. Thus, proper CE mark placement guidelines, requirements, and regulatory steps should be followed. Hence, we have listed some common mistakes which you should steer clear off.

• Using a fake or altered CE logo should be completely avoided
• Affixing the CE mark prior to completing conformity assessment
• Skipping technical supporting document prepartion or Declaration of Conformity (DoC)
• Not consulting with a notified body while applying for CE marking for Class II or Class III devices
• Failing to register in the EUDAMED, which is the European database for device registration

How can Pharmadocx Consultants help you easily secure the CE mark for medical devices?

The CE mark for medical devices is a critical indicator that the product complies with EU regulatory expectations and is ready for the European market. Hence, it can be trusted by healthcare professionals. Navigating the complexities of securing the CE mark is a challenging task. It can be a huge ordeal for new entrants in the medical device sector. With the help of the Pharmadocx Consultants team, you can easily secure the CE marking certification. We will help you in the following ways:

1. Identification of applicable EU directives for your device
2. Verification of applicable standards and testing requirements
3. Compile and prepare necessary supporting and technical documents
4. Reviewing marketing materials, labels, and user manuals for compliance and consistency
5. Ensuring adherence to essential requirements
6. Implementing, adjusting, and maintaining a robust quality management system (usually ISO 13485) to meet European standards
7. Conducting risk assessment and management per applicable guidelines
8. Providing application submission guidance and support throughout the process
9. Acting as a communication bridge between the client and regulatory officials

To easily secure the CE mark for medical devices, feel free to drop an email at [email protected] or call/Whatsapp on 9996859227.