Updated: 24th June 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder & CEO)
What is CE marking?
Before a medical device or in vitro diagnostic medical device (IVD) can be placed on the European Union market, the manufacturer must demonstrate that it complies with the applicable regulatory requirements. This is achieved through the CE marking process, which confirms that the device has undergone the appropriate conformity assessment procedures and satisfies the relevant safety, performance and quality requirements of the EU Medical Device Regulation (EU MDR 2017/745) or In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
Obtaining CE marking involves far more than simply affixing the CE symbol to a product. Manufacturers must determine the correct device classification, establish a Quality Management System, prepare compliant Technical Documentation, generate appropriate clinical or performance evidence, implement risk management and post-market surveillance processes, and, where required, successfully complete assessment by a Notified Body before issuing an EU Declaration of Conformity.
Whether you are developing your first Class I medical device, preparing a Class III implant for certification, or bringing an IVD to market under the IVDR, understanding the CE marking pathway is essential for achieving and maintaining access to the European market.
New to the EU MDR?
CE marking is one of the final steps in demonstrating compliance with Regulation (EU) 2017/745. For a complete overview of MDR requirements, including classification, Article 10 obligations, GSPRs, technical documentation, UDI, EUDAMED and post-market surveillance, explore our EU MDR for Beginners Guide.
CE Marking an In Vitro Diagnostic Medical Device?
The CE marking process for in vitro diagnostic medical devices follows the requirements of Regulation (EU) 2017/746, including device classification, performance evaluation, Technical Documentation, conformity assessment, Notified Body involvement and post-market performance follow-up (PMPF). Learn more in our IVDR for Beginners Guide.
What Does CE Marking Actually Mean?
CE marking is a legal declaration by the manufacturer that a medical device or in vitro diagnostic medical device complies with the applicable requirements of the European Union legislation before it is placed on the EU market. For medical devices, this means complying with the Medical Device Regulation (EU MDR 2017/745), while IVDs must comply with the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
Contrary to a common misconception, the CE mark is not a quality award, product endorsement or approval granted by the European Commission. Instead, it demonstrates that the manufacturer has completed the appropriate conformity assessment procedures and can objectively demonstrate that the device meets the applicable safety, performance and regulatory requirements.
For many devices, obtaining CE marking involves far more than preparing a Declaration of Conformity and affixing the CE symbol to the product. Manufacturers must establish and maintain a compliant Quality Management System, prepare Technical Documentation, implement risk management in accordance with ISO 14971, generate appropriate clinical or performance evidence, and establish robust post-market surveillance procedures. These activities collectively demonstrate that the device consistently performs as intended and that any risks have been reduced as far as possible while maintaining an acceptable benefit-risk profile.
The route to CE marking depends primarily on the classification of the device. Lower-risk devices, such as many Class I medical devices, may be self-certified by the manufacturer where permitted by the Regulations. Higher-risk devices, including most Class IIa, Class IIb and Class III medical devices, together with many Class B, C and D IVDs, require an independent conformity assessment by a designated Notified Body before CE marking can be applied. The higher the potential risk presented by the device, the greater the level of independent regulatory scrutiny required.
Ultimately, CE marking provides confidence to healthcare professionals, patients and regulators that a device has been assessed against the relevant legislative requirements and can be legally placed on the European market. However, obtaining CE marking is not the end of the regulatory process. Manufacturers must continue to monitor the safety and performance of their devices through post-market surveillance, vigilance reporting and ongoing regulatory compliance throughout the product’s lifecycle.
How to Obtain CE Marking for a Medical Device
Obtaining CE marking is a structured regulatory process that demonstrates a medical device or in vitro diagnostic medical device complies with the applicable requirements of the EU Medical Device Regulation (EU MDR 2017/745) or In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). Although the exact route varies depending on the classification and intended purpose of the device, every manufacturer must complete a series of key regulatory activities before placing a product on the European market.
Step 1: Determine Whether Your Product Is a Medical Device or IVD
The first step is confirming that your product falls within the scope of the MDR or IVDR. The intended purpose defined by the manufacturer determines whether the product is regulated as a medical device, an in vitro diagnostic medical device or another type of product.
Step 2: Determine the Device Classification
Manufacturers must classify their device using the classification rules set out in Annex VIII of the MDR or IVDR. Device classification determines the level of regulatory scrutiny and whether an independent Notified Body must be involved during conformity assessment.
Medical devices are classified as:
- Class I
- Class IIa
- Class IIb
- Class III
IVDs are classified as:
- Class A
- Class B
- Class C
- Class D
Higher-risk devices require more extensive regulatory evidence and independent assessment before CE marking can be obtained.
Step 3: Implement a Quality Management System
Most manufacturers are expected to operate an appropriate Quality Management System (QMS) that controls the design, manufacture, verification and post-market activities of the device. ISO 13485 is the internationally recognised standard used by most manufacturers to demonstrate compliance with these quality management requirements.
Step 4: Prepare Technical Documentation
Manufacturers must prepare Technical Documentation demonstrating that the device complies with the applicable General Safety and Performance Requirements (GSPRs). This documentation typically includes:
- Device description
- Design information
- Risk Management File
- Clinical Evaluation or Performance Evaluation
- Verification and validation testing
- Labelling and Instructions for Use
- Post-Market Surveillance documentation
The level of documentation required generally increases with device risk.
Step 5: Complete the Appropriate Conformity Assessment
The conformity assessment route depends on the device classification.
Many Class I devices may be self-certified by the manufacturer where permitted by the MDR.
Higher-risk medical devices and many IVDs require assessment by a designated Notified Body before CE marking can be applied.
Step 6: Issue the EU Declaration of Conformity
Once compliance has been demonstrated, the manufacturer prepares and signs an EU Declaration of Conformity confirming that the device meets all applicable legislative requirements.
Step 7: Affix the CE Mark
Following successful completion of the conformity assessment, the CE marking may be affixed to the device, packaging and accompanying documentation. Where a Notified Body has been involved, its four-digit identification number must accompany the CE mark where required by the legislation.
Step 8: Maintain Ongoing Compliance
Obtaining CE marking is not the end of the regulatory process. Manufacturers must continue to maintain compliance throughout the device lifecycle by implementing:
- Post-Market Surveillance (PMS)
- Vigilance reporting
- Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF), where applicable
- Technical Documentation updates
- Quality Management System maintenance
- Periodic regulatory reviews
Failure to maintain ongoing compliance can result in the suspension or withdrawal of CE certification.
CE Marking Requirements by Medical Device Classification
The route to obtaining CE marking depends largely on the classification of your medical device or in vitro diagnostic medical device. Device classification reflects the potential risk associated with the product and determines the level of regulatory scrutiny required before it can be placed on the European market.
As a general principle, lower-risk devices follow simpler conformity assessment procedures, while higher-risk devices require increasingly comprehensive technical documentation, greater clinical or performance evidence, and independent assessment by a designated Notified Body.
Class I Medical Devices
Class I medical devices present the lowest level of risk under the EU MDR. Many non-sterile, non-measuring Class I devices may be self-certified by the manufacturer without the involvement of a Notified Body, provided all applicable regulatory requirements have been met.
Manufacturers must still:
- Prepare compliant Technical Documentation.
- Demonstrate conformity with the General Safety and Performance Requirements (GSPRs).
- Implement an appropriate Quality Management System.
- Complete risk management activities.
- Prepare an EU Declaration of Conformity.
- Register the device where required.
- Implement Post-Market Surveillance.
Certain Class I devices, including sterile (Class Is), measuring (Class Im) and reusable surgical instruments (Class Ir), require limited Notified Body involvement relating to the aspects covered by their classification.
Class IIa Medical Devices
Class IIa devices present a moderate level of risk and require assessment by a designated Notified Body before CE marking can be applied.
In addition to comprehensive Technical Documentation, manufacturers are expected to provide appropriate clinical evidence demonstrating that the device achieves its intended purpose while maintaining an acceptable benefit-risk profile.
The Notified Body reviews both the manufacturer’s Quality Management System and the supporting technical documentation before issuing the relevant certification.
Class IIb Medical Devices
Class IIb devices generally present a higher level of clinical risk and therefore undergo more rigorous conformity assessment procedures than Class IIa devices.
Manufacturers should expect increased scrutiny of areas including:
- Clinical Evaluation.
- Risk Management.
- Biological Evaluation (where applicable).
- Software validation (where applicable).
- Manufacturing controls.
- Post-Market Surveillance planning.
The level of evidence required is typically greater due to the increased potential impact on patient safety.
Class III Medical Devices
Class III medical devices represent the highest-risk products regulated under the MDR. These devices require the most comprehensive conformity assessment process before CE marking can be obtained.
Manufacturers should expect extensive review of:
- Technical Documentation.
- Clinical Evaluation.
- Risk Management.
- Design verification and validation.
- Manufacturing processes.
- Quality Management System effectiveness.
- Post-Market Surveillance and PMCF planning.
Notified Bodies perform detailed assessments before issuing certification, and many Class III devices remain subject to ongoing surveillance throughout their commercial lifecycle.
Manufacturers should expect increased scrutiny of areas including:
- Clinical Evaluation.
- Risk Management.
- Biological Evaluation (where applicable).
- Software validation (where applicable).
- Manufacturing controls.
- Post-Market Surveillance planning.
The level of evidence required is typically greater due to the increased potential impact on patient safety.
What About In Vitro Diagnostic Medical Devices?
The IVDR introduced a completely new risk-based classification system for in vitro diagnostic medical devices.
Rather than using Classes I, IIa, IIb and III, IVDs are classified as:
- Class A
- Class B
- Class C
- Class D
The majority of IVDs now require assessment by a Notified Body before CE marking can be obtained, representing a significant change from the previous In Vitro Diagnostic Directive (IVDD). Manufacturers must demonstrate conformity through robust Technical Documentation, Scientific Validity, Analytical Performance and Clinical Performance evidence, together with ongoing Post-Market Performance Follow-up (PMPF) where applicable.
Key Takeaway
Although the fundamental objective of CE marking is the same for every device—to demonstrate compliance with the applicable European legislation—the conformity assessment pathway becomes progressively more demanding as device risk increases. Understanding your device classification is therefore one of the most important steps in determining the evidence, documentation and regulatory oversight required to successfully obtain and maintain CE marking.
How Long Does It Take to Obtain CE Marking?
The time required to obtain CE marking varies significantly depending on the type of device, its classification, the maturity of the manufacturer’s Quality Management System, and whether a Notified Body is required to perform the conformity assessment. While some lower-risk devices can be CE marked within a matter of weeks, higher-risk devices often require many months of preparation and regulatory review.
One of the biggest factors influencing project timelines is the quality and completeness of the manufacturer’s Technical Documentation. Well-prepared submissions that clearly demonstrate compliance with the EU MDR or IVDR generally progress more smoothly through the conformity assessment process than incomplete or poorly organised submissions, which frequently result in additional review cycles and requests for further information.
The availability of Notified Bodies also has a significant impact on certification timelines. Since the introduction of the MDR and IVDR, many manufacturers have experienced longer waiting times due to increased regulatory scrutiny and limited Notified Body capacity. Planning certification activities well in advance of product launch is therefore essential.
The table below provides a general indication of typical CE marking timelines.
| Device Type | Typical Timescale* |
|---|---|
| Class I medical device (self-certified) | 1–3 months |
| Class Is / Im / Ir medical device | 3–6 months |
| Class IIa medical device | 6–12 months |
| Class IIb medical device | 9–15 months |
| Class III medical device | 12–24 months |
| Class A IVD (non-sterile, self-certified) | 1–3 months |
| Class A sterile IVD | 3–6 months |
| Class B IVD | 6–12 months |
| Class C IVD | 9–18 months |
| Class D IVD | 12–24 months |
*Indicative timeframes only. Actual certification times depend on device complexity, the completeness of Technical Documentation, clinical or performance evidence, manufacturer preparedness, and Notified Body availability.
Factors That Can Delay CE Marking
Several issues commonly extend CE marking projects beyond their planned timelines, including:
- Incomplete or non-compliant Technical Documentation.
- Insufficient Clinical Evaluation or Performance Evaluation evidence.
- Weak Risk Management documentation.
- Delays in verification and validation testing.
- Changes to device design during development.
- Limited availability of Notified Bodies.
- Non-conformities identified during Quality Management System audits.
- Requests for additional information during conformity assessment.
Many of these delays can be significantly reduced by integrating regulatory planning into the product development process from the outset rather than treating CE marking as the final stage before product launch.
Planning Ahead Improves Success
Manufacturers should begin preparing for CE marking as early as possible, ideally during product design and development. Building regulatory requirements into the development lifecycle helps ensure that clinical evidence, risk management, usability engineering, verification testing and Technical Documentation evolve alongside the device, reducing the likelihood of costly delays later in the conformity assessment process.
What Documentation Is Required for CE Marking?
Obtaining CE marking requires manufacturers to compile comprehensive evidence demonstrating that their device complies with the applicable requirements of the EU Medical Device Regulation (EU MDR 2017/745) or In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). This evidence is collectively referred to as the Technical Documentation and forms the foundation of every conformity assessment.
The exact documentation required depends on the classification, intended purpose and complexity of the device. However, every manufacturer must be able to objectively demonstrate that their product is safe, performs as intended and continues to comply throughout its lifecycle.
Typical documentation required for CE marking includes:
| Documentation | Purpose |
|---|---|
| Device Description and Specification | Defines the device, intended purpose, intended users and operating principles. |
| General Safety and Performance Requirements (GSPRs) | Demonstrates conformity with the applicable requirements of Annex I of the MDR or IVDR. |
| Risk Management File | Identifies hazards, estimates and evaluates risks, implements risk control measures and demonstrates an acceptable benefit-risk profile in accordance with ISO 14971. |
| Clinical Evaluation (MDR) | Demonstrates that the medical device achieves its intended clinical purpose using clinical evidence. |
| Performance Evaluation (IVDR) | Demonstrates scientific validity together with analytical and clinical performance for IVDs. |
| Verification and Validation Evidence | Includes laboratory testing, electrical safety, EMC, software validation, biocompatibility, sterilisation validation and other applicable testing. |
| Labelling and Instructions for Use | Demonstrates compliance with the regulatory requirements for labels, symbols and user information. |
| Post-Market Surveillance Documentation | Describes how the manufacturer will continue to monitor the safety and performance of the device once it has been placed on the market. |
| EU Declaration of Conformity | The manufacturer’s formal declaration that the device complies with the applicable legislation and has completed the required conformity assessment procedures. |
What Documentation Is Required for CE Marking?
Many manufacturers mistakenly believe that CE marking simply requires producing a series of standalone reports. In reality, Technical Documentation should present a coherent body of evidence demonstrating that every aspect of the device has been designed, manufactured, verified and validated in accordance with the applicable regulatory requirements.
For example, the Clinical Evaluation should support the intended purpose described in the Device Description, while the Risk Management File should identify and evaluate hazards associated with that intended use. Verification testing should confirm that identified risks have been effectively controlled, and the Post-Market Surveillance system should monitor whether those conclusions remain valid once the device is commercially available. Regulators and Notified Bodies expect this evidence to be consistent, traceable and maintained throughout the entire product lifecycle.
Documentation Must Be Maintained Throughout the Product Lifecycle
Preparing Technical Documentation is not a one-time activity completed before CE marking is obtained. Manufacturers are responsible for keeping documentation up to date whenever there are significant changes to the device, applicable standards, clinical evidence, manufacturing processes or regulatory requirements.
Maintaining accurate and current documentation supports ongoing compliance, facilitates Notified Body surveillance activities and helps demonstrate that the device continues to meet the requirements of the MDR or IVDR after it has been placed on the market.
Need Help Structuring Your Technical Documentation?
Preparing Technical Documentation is one of the most important steps in obtaining CE marking under the EU MDR and IVDR. Learn how to structure a compliant Technical File in accordance with Annexes II and III, including device descriptions, GSPRs, risk management, clinical or performance evaluation, verification and validation, and post-market surveillance, in our Medical Device Technical File Guide.
What Is the Role of a Notified Body in CE Marking?
A Notified Body is an independent organisation designated by a Member State to assess whether certain medical devices and in vitro diagnostic medical devices comply with the requirements of the EU MDR or IVDR before they can be placed on the European market. Notified Bodies play a critical role in the conformity assessment process for higher-risk devices, providing an independent review of the manufacturer’s evidence before CE marking can be applied.
Not every device requires a Notified Body. Many lower-risk products, such as most Class I medical devices and non-sterile Class A IVDs, can be self-certified by the manufacturer, provided all applicable regulatory requirements have been met. However, as device risk increases, independent assessment becomes mandatory.
When Is a Notified Body Required?
The requirement for Notified Body involvement depends primarily on the device classification.
| Device Classification | Notified Body Required? |
|---|---|
| Class I Medical Device | Usually No* |
| Class Is, Im and Ir | Yes |
| Class IIa | Yes |
| Class IIb | Yes |
| Class III | Yes |
| Class A IVD (Non-Sterile) | No |
| Class A Sterile IVD | Yes (Sterility Aspects Only) |
| Class B IVD | Yes |
| Class C IVD | Yes |
| Class D IVD | Yes |
*Except where special conformity assessment procedures apply under the MDR.
What Does a Notified Body Assess?
During the conformity assessment process, the Notified Body reviews the manufacturer’s Technical Documentation and Quality Management System to verify compliance with the applicable legislation. Depending on the classification and conformity assessment route, this assessment may include:
- Reviewing the Technical Documentation.
- Assessing compliance with the General Safety and Performance Requirements (GSPRs).
- Evaluating Clinical Evaluation Reports or Performance Evaluation Reports.
- Reviewing the Risk Management File.
- Assessing verification and validation evidence.
- Auditing the manufacturer’s Quality Management System, typically against ISO 13485.
- Conducting surveillance audits following certification.
- Reviewing significant changes made to the device after certification.
For the highest-risk devices, the review process is significantly more detailed and may involve multiple rounds of questions, requests for clarification and additional evidence before certification can be granted.
Choosing the Right Notified Body
Manufacturers should engage with a Notified Body as early as possible during product development. Capacity remains limited for many MDR and IVDR designations, and early engagement can help avoid unnecessary delays in product launch.
When selecting a Notified Body, manufacturers should consider factors such as:
- Designation for the relevant device codes.
- Experience with similar technologies.
- Availability and expected review timelines.
- Geographic location and language.
- Audit approach and communication.
- Long-term availability for surveillance and recertification activities.
Selecting a Notified Body with appropriate expertise can make the conformity assessment process more efficient and help ensure a smoother route to CE marking.
Need to Understand Notified Bodies?
Most medical devices and in vitro diagnostic medical devices require assessment by a Notified Body before they can be CE marked under the EU MDR or IVDR. Learn how Notified Bodies are designated, when they are required, how to choose the right organisation and what to expect during the conformity assessment process in our Guide to Medical Device Notified Bodies.
What Happens After Your Device Receives CE Marking?
Receiving CE marking is a significant regulatory milestone, but it is not the end of a manufacturer’s obligations. Under both the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), manufacturers are responsible for continually monitoring the safety, performance and regulatory compliance of their devices throughout their entire lifecycle.
Once a device has been placed on the market, manufacturers must actively collect and evaluate information from real-world use to confirm that the device continues to perform as intended and that any emerging risks are identified and managed appropriately. This ongoing process helps ensure that patients and users remain protected while maintaining compliance with European legislation.
Key Post-Market Responsibilities
Following CE marking, manufacturers are typically required to:
- Maintain and continually improve their Quality Management System.
- Operate a documented Post-Market Surveillance (PMS) system.
- Collect and analyse customer feedback, complaints and service data.
- Investigate incidents, adverse events and non-conformities.
- Report serious incidents and Field Safety Corrective Actions (FSCAs) to the relevant Competent Authorities within the required timescales.
- Keep Technical Documentation up to date as new information becomes available.
- Review and update Risk Management documentation throughout the product lifecycle.
- Update the Clinical Evaluation Report (CER) or Performance Evaluation Report (PER) where appropriate.
- Conduct Post-Market Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF) activities where required.
- Cooperate with Notified Body surveillance audits for applicable devices.
These activities demonstrate that compliance is maintained continuously rather than only at the point of certification.
Regulatory Compliance Is a Continuous Process
Medical devices and IVDs may evolve over time as manufacturers introduce design changes, manufacturing improvements, software updates or new clinical evidence. Significant changes may require updates to the Technical Documentation, additional validation activities or, in some cases, approval from the Notified Body before implementation.
Manufacturers should also remain aware of changes to harmonised standards, common specifications and regulatory guidance that could affect ongoing compliance. Regular reviews of the Quality Management System and Technical Documentation help ensure that devices continue to meet the latest regulatory expectations.
The Importance of Effective Post-Market Surveillance
An effective Post-Market Surveillance system enables manufacturers to identify trends, detect emerging safety issues and implement corrective actions before problems become widespread. The information gathered through PMS also feeds back into risk management, clinical or performance evaluation and product improvement, creating a continuous cycle of regulatory compliance and quality enhancement.
By treating CE marking as the beginning of an ongoing commitment to safety and performance, rather than the end of the regulatory journey, manufacturers are better positioned to maintain compliance and support the long-term success of their products in the European market.
Need to Understand Post-Market Surveillance?
CE marking is only the beginning of a medical device's regulatory lifecycle. Learn how to develop a compliant Post-Market Surveillance (PMS) system under the EU MDR, including PMS Plans, PMS Reports, PSURs, vigilance, trend reporting, PMCF, Risk Management integration and ongoing regulatory compliance in our Guide to Post-Market Surveillance for Medical Devices.
Common CE Marking Mistakes to Avoid
Obtaining CE marking is a structured process that requires careful planning, robust documentation and ongoing regulatory compliance. While every device is different, many manufacturers encounter similar challenges that can delay certification, increase costs or result in non-conformities during Notified Body review.
Understanding these common pitfalls can help manufacturers prepare more effectively and achieve a smoother route to market.
1. Leaving Regulatory Compliance Until the End
One of the most common mistakes is treating CE marking as a final administrative task rather than an integral part of product development. Regulatory requirements should be considered from the earliest design stages so that risk management, clinical evidence, verification testing and Technical Documentation are developed alongside the device.
2. Inadequate Technical Documentation
Technical Documentation is one of the most frequently scrutinised areas during conformity assessment. Missing evidence, inconsistent information or poorly organised documentation can lead to lengthy review cycles and requests for additional information from a Notified Body.
Manufacturers should ensure that their documentation is complete, traceable and maintained throughout the device lifecycle.
3. Underestimating Clinical or Performance Evidence Requirements
Clinical Evaluation under the MDR and Performance Evaluation under the IVDR are often more demanding than manufacturers expect. Regulators require objective evidence demonstrating that a device achieves its intended purpose while maintaining an acceptable benefit-risk profile.
Insufficient clinical or performance evidence remains one of the leading causes of delays during conformity assessment.
4. Failing to Maintain an Effective Quality Management System
A compliant Quality Management System is fundamental to CE marking. Manufacturers should ensure that procedures are fully implemented, records are maintained and internal audits, management reviews and corrective actions are performed regularly.
Certification is based on demonstrating that quality processes are effective in practice, not simply documented on paper.
5. Delaying Engagement with a Notified Body
Manufacturers of higher-risk devices should engage with a Notified Body as early as possible. Waiting until Technical Documentation has been completed can significantly delay product launch due to limited assessment capacity and lengthy review times.
Early planning allows manufacturers to understand the conformity assessment route, allocate sufficient resources and build realistic project timelines.
6. Treating CE Marking as the End of Compliance
Receiving CE marking does not remove a manufacturer’s regulatory obligations. Ongoing Post-Market Surveillance, vigilance reporting, risk management updates and Technical Documentation maintenance are all essential for maintaining compliance throughout the product’s lifecycle.
Manufacturers who establish robust lifecycle processes are generally better prepared for surveillance audits and future regulatory changes.
Best Practice for a Successful CE Marking Project
Successful CE marking projects begin with early planning, a well-implemented Quality Management System and clear regulatory strategy. By integrating regulatory requirements into product development, maintaining comprehensive Technical Documentation and proactively engaging with Notified Bodies where required, manufacturers can reduce delays, minimise compliance risks and bring safe, effective devices to market more efficiently.
Conclusion
CE marking is far more than applying a symbol to a product. It demonstrates that a medical device or in vitro diagnostic medical device has undergone the appropriate conformity assessment and complies with the requirements of the EU MDR or IVDR before being placed on the European market.
Whether a device is self-certified or requires assessment by a Notified Body, manufacturers must establish an appropriate Quality Management System, prepare comprehensive Technical Documentation, generate suitable clinical or performance evidence and maintain compliance throughout the product’s lifecycle. Post-Market Surveillance, risk management and continual improvement remain essential long after CE marking has been achieved.
Understanding the regulatory pathway early, preparing robust documentation and embedding compliance into product development can significantly reduce delays and improve the likelihood of a successful conformity assessment. By taking a proactive approach, manufacturers can navigate the CE marking process more efficiently while ensuring their devices continue to meet the highest standards of safety and performance.
How can Patient Guard Help?
Working with a Regulatory and Quality Assurance partner such as Patient Guard can reduce the administrative burden and reduce the likelihood of costly mistakes, such as nonconformities raised during Notified Body visits which can cost a lot of money in new audit days being added or extra review days.
Contact us to see how we can help with your CE marking journey for medical devices and IVDs.
Frequently Asked Questions About CE Marking of Medical Devices and IVDs
CE marking is a certification that indicates a medical device or in vitro diagnostic (IVD) complies with the European Union’s regulatory requirements under the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746). It signifies that the product is safe, effective, and fit for its intended purpose.
Key insight: CE marking is mandatory for selling medical devices and IVDs in the EU and EEA.
CE marking ensures:
- Regulatory Compliance: Demonstrates adherence to EU regulations.
- Market Access: Allows products to be sold in the EU and EEA.
- Patient Safety: Confirms the device meets stringent safety and performance standards.
Why it matters: Without CE marking, a product cannot be legally marketed in the EU.
The CE marking process involves:
- Determine Classification: Identify the device’s risk class (Class I, IIa, IIb, or III) or IVD classification under the MDR/IVDR.
- Technical Documentation: Prepare comprehensive documentation, including device description, risk analysis, and clinical evaluation.
- Quality Management System (QMS): Implement a QMS, such as ISO 13485, to ensure consistent quality.
- Conformity Assessment: Work with a Notified Body (if applicable) to verify compliance.
- Labeling and Instructions for Use (IFU): Ensure labeling meets EU requirements.
- Declaration of Conformity: Declare the device’s conformity with MDR or IVDR requirements.
- Affix CE Marking: Place the CE mark on the device and associated packaging.
Pro tip: Partnering with regulatory experts can streamline the process and ensure compliance.
For IVDs, classification and requirements under IVDR are stricter compared to the previous directive (IVDD). Steps include:
- Determine IVD Classification: Based on risk (A, B, C, or D).
- Performance Evaluation: Conduct analytical and clinical performance studies.
- Notified Body Involvement: Required for all but Class A non-sterile IVDs.
- Post-Market Surveillance (PMS): Plan and implement PMS activities.
Key takeaway: Higher-risk IVDs (e.g., those for infectious diseases) face more rigorous evaluation.
Medical devices are classified based on risk:
- Class I: Low risk (e.g., reusable surgical instruments).
- Class IIa: Moderate risk (e.g., diagnostic ultrasound devices).
- Class IIb: Higher risk (e.g., infusion pumps).
- Class III: Highest risk (e.g., implantable pacemakers).
Tip for manufacturers: Proper classification is critical to determine the level of regulatory scrutiny.
Key documents include:
- Technical File: Detailed information about the device, including design, manufacturing, and testing data.
- Risk Management File: In accordance with ISO 14971.
- Clinical Evaluation Report (CER): Evidence of safety and performance.
- Performance Evaluation Report (PER): For IVDs, detailing analytical and clinical studies.
- Post-Market Surveillance Plan: Strategy for monitoring the device’s performance after market entry.
- Declaration of Conformity: Manufacturer’s statement of compliance.
Best practice: Maintain thorough and up-to-date documentation for audits or inspections.
A Notified Body is an independent organization designated by the EU to assess medical devices and IVDs for compliance with MDR/IVDR. Their role includes:
- Reviewing technical documentation.
- Auditing quality management systems.
- Conducting conformity assessments.
- Issuing CE certificates for Class IIa, IIb, III, and high-risk IVDs.
Key insight: Not all devices require Notified Body involvement—low-risk devices (Class I non-sterile) can be self-certified.
Post-market surveillance (PMS) ensures ongoing safety and performance of a device after it enters the market. Key activities include:
- Collecting and analyzing user feedback.
- Monitoring adverse events and trends.
- Implementing corrective actions when necessary.
Why it matters: PMS is mandatory under MDR/IVDR and critical for maintaining CE marking.
CE certificates issued by Notified Bodies are typically valid for five years. However, manufacturers must ensure ongoing compliance and renew the certificate before expiration.
Tip for manufacturers: Start the renewal process early to avoid market disruptions.
Non-compliance can lead to:
- Fines and penalties from EU regulatory authorities.
- Market withdrawal of the product.
- Reputational damage and loss of market trust.
Key takeaway: Staying compliant ensures uninterrupted market access and protects patients.
Yes! Patient Guard provides comprehensive CE marking support, including:
- Assisting with technical documentation preparation.
- Developing risk management and clinical evaluation reports.
- Supporting quality management system (ISO 13485) implementation.
- Coordinating Notified Body submissions and audits.
- Acting as your EU Authorized Representative for non-EU manufacturers.
Why choose Patient Guard: With years of experience and expertise, we help ensure your device meets all MDR and IVDR requirements for successful market entry.
References
This guide is based on the following legislation and official regulatory guidance relating to CE marking of medical devices under Regulation (EU) 2017/745 (MDR).
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (MDR) | Provides the legal framework governing CE marking of medical devices, including classification, conformity assessment procedures, technical documentation, Declaration of Conformity and the requirements for affixing the CE mark. |
| European Commission | European Commission Medical Device Guidance | Provides official guidance documents supporting implementation of the MDR, including conformity assessment, clinical evaluation, technical documentation, classification and CE marking requirements. |
| European Commission | Notified Bodies for Medical Devices | Explains the designation, responsibilities and role of Notified Bodies in assessing conformity and issuing CE certificates for medical devices requiring third-party assessment. |
| European Commission | EU Declaration of Conformity (DoC) | Explains the purpose, content and regulatory requirements of the EU Declaration of Conformity, which manufacturers must prepare before affixing the CE mark. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | Defines the internationally recognised Quality Management System requirements that support manufacturers in achieving and maintaining CE marking compliance under the MDR. |
CE marking requirements and regulatory guidance continue to evolve. Manufacturers should always consult the latest published legislation and official guidance when planning conformity assessment, preparing technical documentation and placing CE-marked medical devices on the European market.
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IVDR Performance Evaluation Explained: A Complete Guide for Manufacturers
Performance Evaluation is one of the most important requirements under the EU In Vitro Diagnostic Regulation (IVDR). Every manufacturer must demonstrate that their in vitro diagnostic medical device achieves its intended purpose through robust scientific validity, analytical performance and clinical performance evidence. This guide explains every stage of IVDR Performance Evaluation, including Performance Evaluation Plans (PEPs), Performance Evaluation Reports (PERs), Post-Market Performance Follow-up (PMPF) and how Performance Evaluation supports successful CE marking under Regulation (EU) 2017/746.
IVDR Classification Explained: A Complete Guide to Class A, B, C and D IVDs
Understanding how your in vitro diagnostic device is classified under the EU IVDR is one of the first and most important steps towards regulatory compliance. This guide explains the IVDR classification rules, the differences between Class A, B, C and D IVDs, how Annex VIII is applied, and how classification affects conformity assessment, technical documentation and Notified Body involvement.
When Do You Need New Biocompatibility Testing for a Medical Device?
A material change, supplier switch, manufacturing transfer or design modification does not automatically require new ISO 10993 biocompatibility testing. Learn how manufacturers use Biological Evaluation Plans (BEPs), chemical characterisation, toxicological risk assessments and Biological Evaluation Reports (BERs) to determine whether existing biological evidence remains valid or whether additional testing is required under ISO 10993-1, the EU MDR and FDA expectations.
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