CE Marking for Medical Devices: Definition, Requirements, and How to Get It

CE marking is a certification that indicates that a medical device or in vitro diagnostic device (IVD) meets European Union (EU) regulatory requirements and is safe and effective for its intended use.

CE marking is required for all medical devices and IVDs placed on the EU market, regardless of device risk class. It is the manufacturer’s responsibility to affix the CE mark before market placement. Authorized Representatives, importers, and distributors have defined obligations to verify compliance of CE-marked devices. The CE mark serves as official confirmation that the product complies with all relevant EU safety, performance, and labeling requirements.

To place a medical device or IVD on the EU market, manufacturers must meet the core regulatory requirements outlined in MDR 2017/745 or IVDR 2017/746. These include accurate device classification, completion of an appropriate conformity assessment procedure, generation of technical documentation aligned with Annexes II and III, and execution of a clinical evaluation (MDR) or performance evaluation (IVDR).

Additional requirements include implementation of a compliant Quality Management System (typically aligned with ISO 13485), issuance of an EU Declaration of Conformity (DoC), assignment of a Unique Device Identifier (UDI), affixing the CE mark, and fulfillment of post-market surveillance (PMS) requirements.

To comply with these regulatory requirements, manufacturers must follow a structured CE marking process. This includes identifying the applicable regulatory framework (EU MDR 2017/745 or EU IVDR 2017/746), classifying the device based on risk rules (Annex VIII), determining whether Notified Body involvement is required, and selecting the appropriate conformity assessment route. Manufacturers must then implement and maintain an ISO 13485-compliant QMS, compile technical documentation, prepare a Clinical Evaluation Report (CER) or Performance Evaluation Report (PER), and undergo audits or assessments where applicable. Post-certification, the manufacturer must ensure continuous regulatory compliance through PMS and vigilance systems.

QMS software, such as SimplerQMS, significantly streamlines the CE marking process. QMS software supports compliance by streamlining document control, traceability, training, audit readiness, and other QMS activities across the full device lifecycle. This helps ensure regulatory alignment with MDR, IVDR, and ISO 13485, while reducing manual workload and risk of noncompliance.

What Is CE Certification?

“CE” stands for Conformité Européenne, which translates to “European Conformity.” CE certification is a formal declaration by a manufacturer that their product complies with all applicable European Union (EU) regulatory requirements.

For medical devices, CE marking certification signifies that the device meets the requirements of the EU Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Regulation (IVDR 2017/746), depending on device type, and has undergone the appropriate conformity assessment process.

The purpose of CE marking for medical devices is to confirm that the product is safe for the intended patient or user population, performs as intended, and complies with all EU regulatory requirements. CE marking allows the device to be legally marketed and distributed within the European Economic Area (EEA).

Who Needs CE Marking for Medical Devices?

CE marking is mandatory for all manufacturers placing medical devices or in vitro diagnostic (IVD) medical devices on the European Economic Area (EEA) market, regardless of their geographic location.

CE marking is mandatory for all classes of medical devices under EU MDR 2017/745 and EU IVDR 2017/746. Under EU MDR 2017/745, medical devices are classified into Class I, including Is (sterile), Im (measuring), Ir (reusable), IIa, IIb, and III. Under EU IVDR 2017/746, IVDs are classified as Class A (including Class A sterile), B, C, and D.

The manufacturer of the medical device or IVD device is legally responsible for obtaining CE marking. EU-based authorized representatives act as a legal liaison with EU authorities for non-EU manufacturers and must verify that the manufacturer has fulfilled the CE marking obligation. EU importers and distributors are also required to verify that the devices have been CE marked.

CE marking is required for market access in all European Economic Area (EEA) countries. EEA countries include EU member states and Iceland, Liechtenstein, and Norway. The CE mark is also recognized and accepted in a number of other non-EU countries, such as Switzerland and Turkey.

What Regulations and Regulatory Authorities Govern CE Marking?

CE marking for medical devices is governed by Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

EU MDR 2017/745 and EU IVDR 2017/746 establish the legal framework for placing medical and IVD devices on the EU market. Both regulations define classification rules, conformity assessment procedures, clinical and performance evaluation, post-market surveillance, and requirements for establishing and maintaining technical documentation.

Notified Bodies are independent conformity assessment organizations designated by EU member states and listed in the NANDO (New Approach Notified and Designated Organisations) database. For Class IIa, IIb, and III medical devices and Class B, C, and D IVDs, manufacturers must engage a Notified Body to assess the QMS, review the Technical Documentation (Annexes II & III), and issue an EU certificate of conformity as part of the CE marking process. While most Class I medical devices and Class A IVDs are self-certified by the manufacturer, certain subclasses, such as Class Is, Im, Ir medical devices and Class A Sterile IVDs, require Notified Body involvement for specific aspects such as sterility, measuring function, and reusability.

CE marking may also intersect with horizontal EU legislation where product components, materials, or environmental impact fall under additional regulatory scopes.

The horizontal EU legislations that CE marking may intersect with are listed below. 

• REACH (Registration, Evaluation, Authorization and Restriction of Chemicals): REACH (EC No. 1907/2006) is an EU regulation that governs the manufacture and use of chemical substances in the European Economic Area (EEA). REACH requires manufacturers to evaluate and register hazardous substances used in device materials, ensuring safe use and disclosure in the technical file and labeling.
• RoHS (Restriction of Hazardous Substances Directive): RoHS (2011/65/EU) is an EU directive that restricts the use of specific hazardous substances in electrical and electronic equipment. The aim of RoHS is to reduce environmental impact and health risks. This regulation establishes requirements for limiting the use of specific hazardous substances such as lead, mercury, and cadmium in electrical and electronic equipment.
• WEEE (Waste Electrical and Electronic Equipment Directive): WEEE (2012/19/EU) is an EU directive that sets requirements for the collection, recycling, and environmentally responsible disposal of electrical and electronic equipment. The aim of WEEE is to reduce electronic waste and promote sustainable resource use across the EU. This regulation establishes requirements for the collection, treatment, and environmentally responsible recovery of electronic devices in the EU.

When applicable, compliance with these horizontal directives must be demonstrated within the Technical Documentation submitted for CE marking. Manufacturers must integrate relevant risk assessments and declarations into the conformity assessment procedure.

CE marking is not equivalent to FDA approval. CE marking signifies that the device conforms to applicable EU regulatory requirements for marketing within the European Economic Area (EEA). FDA approval or clearance is based on separate premarket pathways under 21 CFR Parts 800–898 for distribution in the United States.

CE marking is also distinct from UKCA marking. UKCA (UK Conformity Assessed) marking is required for market access in Great Britain (England, Scotland, and Wales). UKCA marking operates under the UK MDR 2002 (as amended). The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

Why Is CE Marking Important in the Medical Device Industry?

CE marking is important in the medical industry since it is a regulatory requirement for placing medical and IVD devices on the EU market. A CE mark confirms that the device meets all applicable conformity assessment requirements under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).

CE marking signifies that the device complies with the General Safety and Performance Requirements (GSPRs). CE marking also indicates that the device has undergone appropriate conformity assessment procedures either via self-declaration or Notified Body certification. With regards to QMS, it ensures that the manufacturer has implemented a fully compliant QMS, typically aligned with ISO 13485. Finally, it also indicates that the device is supported by technical documentation, including clinical or performance evaluation, and is subject to continuous post-market surveillance.

The absence of CE marking constitutes non-compliance with EU regulatory requirements. This means the device is ineligible for placement or distribution in the EEA. Regulatory consequences include prohibition from market access, product seizure, enforcement actions from Competent Authorities, withdrawal of certificates, and reputational damage.

What Are the CE Marking Requirements for Medical Devices?

CE marking requirements are outlined in EU MDR 2017/745 and EU IVDR 2017/746, which define regulatory requirements across the device lifecycle, from conformity assessment and market placement to post-market surveillance and vigilance.

The CE marking requirements for medical devices and IVD devices are listed below.

1. Device Classification: Devices must be classified under MDR Annex VIII or IVDR Annex VIII based on factors such as intended purpose, invasiveness, and duration of use. Device classification determines the conformity assessment pathway and Notified Body involvement.
2. Conformity Assessment Procedure: Manufacturers must apply the appropriate conformity assessment route (EU MDR 2017/745 and EU IVDR 2017/746 Annex IX, X, XI), including Notified Body QMS audits, Technical Documentation review, and verification of device conformity with General Safety and Performance Requirements (GSPRs).
3. Technical Documentation: Technical Documentation must be prepared in compliance with MDR/IVDR Annex II and III, and include full traceability through design and manufacturing controls, risk management, verification/validation, and labeling.
4. Clinical or Performance Evaluation: EU MDR 2017/745 requires a Clinical Evaluation per Annex XIV to confirm safety and clinical benefit. EU IVDR 2017/746 requires a Performance Evaluation per Annex XIII, including scientific validity, analytical performance, and clinical performance data.
5. Quality Management System (QMS): A QMS must be implemented to meet requirements as per MDR Article 10(9) and IVDR Article 10(8). This covers design control, production, clinical and performance evaluation, CAPA, and Post-Market Surveillance (PMS).
6. Declaration of Conformity: The manufacturer must issue and sign a Declaration of Conformity (DoC) per Article 19 under EU MDR 2017/745 or Article 17 under EU IVDR 2017/746, ensuring compliance with the applicable regulatory requirements.
7. CE Marking and UDI Assignment: Devices must bear the CE mark in accordance with Article 20 under EU MDR 2017/745 or Article 18 under EU IVDR 2017/746. Unique Device Identifiers (UDIs) must be assigned, maintained, and uploaded to EUDAMED per Annex VI of EU MDR 2017/745 and EU IVDR 2017/746.
8. Post-Market Surveillance (PMS) and Vigilance: A PMS system must be implemented as per Article 83 of EU MDR 2017/745 or Article 78 of EU IVDR 2017/746, supported by a vigilance system, trend reporting, Field Safety Corrective Actions (FSCAs), and Periodic Safety Update Reports (PSURs) for higher-risk classes.
9. Requirements for Economic Operators: Under Articles 11–16 of EU MDR 2017/745 and EU IVDR 2017/746, specific responsibilities are assigned to manufacturers, authorized representatives, importers, and distributors. These include verification of CE marking, ensuring regulatory compliance, and maintaining appropriate documentation to demonstrate conformity.
10. EUDAMED Registration Requirements: Manufacturers, authorized representatives, and importers must register in EUDAMED per Articles 29 and 31 of EU MDR 2017/745 and Articles 26 and 28 of EU IVDR 2017/746, including device, UDI-DI, and economic operator data.
11. Notified Body Involvement and Certification: For higher-risk devices (Class Is, Im, Ir, IIa, IIb, III under MDR; Class A (Sterile), B, C, D under IVDR), engagement with a designated Notified Body is mandatory. This includes conformity assessment audits and technical documentation reviews. This also includes issuance of CE certificates per Annex XII of the EU MDR 2017/745 and EU IVDR 2017/746.
12. Labeling and IFU Requirements: As outlined in Annex I, Section 23 of EU MDR 2017/745 and Annex I, Section 20 of the EU IVDR 2017/746, device labeling and instructions for use must meet language and traceability requirements. Specific elements include manufacturing information, UDI carrier, CE mark placement, storage conditions, and warnings.

How to Get CE Marking for Medical Devices?

To get CE marking for medical devices, follow the steps listed below.

1. Determine Your Device Classification: Classify your device under EU MDR 2017/745 (Class I, IIa, IIb, III) or IVDR 2017/746 (Class A–D) based on risk, invasiveness, and intended use. Classification dictates the conformity assessment route and whether a Notified Body (NB) must be involved.
2. Designate a Person Responsible for Regulatory Compliance (PRRC): Appoint a qualified PRRC per Article 15 of EU MDR 2017/745 and EU IVDR 2017/746 to oversee QMS, Technical Documentation, vigilance, and PMS activities. Small and micro enterprises are not required to have the PRRC within their organization. However, they must have a PRRC that is permanently and continuously at their disposal.
3. Implement a Quality Management System (QMS): Establish a QMS aligned with ISO 13485:2016, EU MDR 2017/745, and EU IVDR 2017/746 requirements (Annex IX/XI) to manage design, manufacturing, risk, and post-market processes. QMS effectiveness is subject to NB audit during conformity assessment.
4. Implement a Risk Management System: Develop a risk management system per ISO 14971:2019 covering the full product lifecycle and demonstrating an acceptable benefit-risk ratio. Maintain a traceable risk management file including hazard analysis, risk assessment, risk controls, and residual risk evaluation.
5. Prepare Technical Documentation: Compile technical documentation as per Annex II and III of EU MDR 2017/745 and EU IVDR 2017/746, demonstrating conformity with GSPRs. Include clinical/performance evidence, design specifications, labeling, and traceability to applicable standards (for example, IEC 62304 for software).
6. Implement a Supplier Management System: Establish risk-based procedures for supplier qualification, quality agreements, performance monitoring, and requalification. Significant supplier changes (contract manufacturer switch) require NB notification and updates to Technical Documentation.
7. Conduct a Clinical Evaluation or Performance Evaluation: Perform Clinical Evaluation (Annex XIV, EU MDR 2017/745) or Performance Evaluation (Annex XIII, EU IVDR 2017/746) to demonstrate safety and performance. Document findings in a Clinical Evaluation Report (CER) for medical devices or a Performance Evaluation Report (PER) for IVDs and update via Post-Market Clinical Follow-Up (PMCF) or Post-Market Performance Follow-Up (PMPF) activities, respectively.
8. Assign an Authorized Representative (if outside EU): Non-EU manufacturers must designate an EU Authorized Representative per Article 11 EU MDR 2017/745 and EU IVDR 2017/746 to act as the regulatory liaison. Responsibilities include documentation verification, vigilance, and representation in regulatory audits, among other activities.
9. Obtain CE Certification by a Notified Body: Engage a NB for conformity assessment for Class Is, Ir, Im, IIa, IIb, III, and Class A (Sterile), B, C, D IVDs. Submit QMS evidence, technical documentation, and clinical/performance data. A successful review results in CE certification.
10. Draw Up the EU Declaration of Conformity (DoC): Draft a legally binding DoC as per Annex IV of EU MDR 2017/745 and EU IVDR 2017/746, affirming full compliance with applicable GSPRs and conformity procedures. Include manufacturer details, Basic UDI-DI (Device Identifier), NB certificate reference, and ensure it is signed by an authorized person, for example, PRRC.
11. Register Your Device Under a Unique Device Identifier (UDI): Assign UDI-DI (Device Identifier) and UDI-PI (Production Identifier) per Article 27 under EU MDR 2017/745 and Article 24 under EU IVDR 2017/746 and Annex VI. Ensure consistent use across labeling, technical documentation, and post-market records.
12. Affix the CE Marking: Apply the CE mark visibly and indelibly to the device and packaging before market release as per Article 20 of EU MDR 2017/745 and Article 18 of EU IVDR 2017/746.
13. Submit Device and UDI Registration in European Database on Medical Devices (EUDAMED): Upload UDI device data, certificates, and economic operator information in EUDAMED to ensure regulatory transparency and traceability, as required under Article 33 of EU MDR 2017/745 and Article 30 of EU IVDR 2017/746. While EUDAMED use is currently voluntary, these requirements will become mandatory after full system rollout.
14. Maintain a Post-Market Surveillance (PMS) System: Establish a proactive PMS system per Article 83 of EU MDR 2017/745 and Article 78 of EU IVDR 2017/746 to monitor and evaluate device safety and performance.

1. Determine Your Device Classification

The first step to obtaining CE marking is to determine the correct classification of your medical device under EU MDR 2017/745 or IVDR 2017/746, based on its intended purpose, risk profile, mode of action, and design characteristics.

Under MDR, medical devices are classified into four classes, namely, Class I, IIa, IIb, and III, as defined in Annex VIII. MDR medical device classification is based on criteria such as duration of use (transient, short-term, long-term), invasiveness (non-invasive, invasive, surgically invasive, implantable), and risk to the patient or user. For example, a non-invasive medical device such as a stethoscope falls under Class I, while a long-term implantable cardiac device such as a pacemaker would fall under Class III, reflecting its higher risk profile.

Under IVDR device classification, in vitro diagnostic devices are classified into Class A, B, C, and D. High-risk devices like blood screening assays (HIV tests) are classified as Class D, while general laboratory instruments may fall under Class A.

Correct classification determines the conformity assessment route and whether a Notified Body must be involved. Incorrect classification can lead to regulatory noncompliance, delays, or market withdrawal. Manufacturers can self-certify and CE mark certain low-risk devices without Notified Body involvement. This is possible for Class I medical devices that are non-sterile, non-measuring, and non-reusable surgical instruments, as well as Class A IVD devices, which are non-sterile. For all other device classes, involvement of a designated Notified Body is mandatory, and CE marking must follow a formal conformity assessment procedure.

2. Designate a Person Responsible for Regulatory Compliance (PRRC)

Manufacturers must appoint a Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 of EU MDR 2017/745 and EU IVDR 2017/746.

The PRRC must possess a formal qualification in law, medicine, pharmacy, engineering, or another relevant scientific discipline, along with at least one year of regulatory or QMS experience or four years of experience if no formal qualification is held.

This individual ensures ongoing compliance with QMS, Technical Documentation (Annexes II & III), vigilance reporting, and Post-Market Surveillance (PMS) requirements.

Smaller manufacturers may outsource the PRRC role. However, such manufacturers must have a written agreement in place and ensure the PRRC is permanently and continuously available.

3. Implement a Quality Management System (QMS)

To obtain CE marking, manufacturers must implement a QMS that aligns with the requirements of EU MDR 2017/745 or IVDR 2017/746 and supports conformity assessment procedures.

It is considered best practice for a medical device QMS to fulfil ISO 13485 requirements, although this is not a regulatory requirement. ISO 13485 is a widely accepted, harmonized standard for establishing a medical device QMS, in particular for Annex IX and XI conformity assessments involving Notified Bodies. These notified body audits assess the effectiveness of the manufacturer’s QMS.

The QMS must include documented procedures for design and development, production and process control, risk management (per ISO 14971), complaint handling, CAPA, PMS, and supplier management. 

4. Implement a Risk Management System

Manufacturers must implement a risk management system to identify, analyze, evaluate, control, and monitor risks throughout the medical device lifecycle.

The risk management process should align with the requirements of ISO 14971:2019, the harmonized standard for risk management in medical devices. The risk management system must cover the entire product lifecycle from design inputs and usability engineering through to production and post-market surveillance. This ensures that all risks, including any residual risks after the implementation of risk control measures, are reduced to an acceptable level. Acceptability is determined based on a benefit-risk analysis, ensuring that the expected benefits of the device outweigh any potential risks.

Manufacturers must establish a risk management file that includes, at a minimum, a risk management plan, hazard identification, risk assessment, and benefit-risk analysis. It should also document the implementation and verification of control measures, evaluation of residual risks, risk acceptability decisions, and processes for ongoing risk monitoring and review.

For example, when integrating software into a diagnostic device, potential failure modes, such as data corruption, must be anticipated and mitigated through design controls, validation, and verification activities to ensure safe and effective device performance.

5. Prepare Technical Documentation

Manufacturers must prepare technical documentation to demonstrate conformity with the General Safety and Performance Requirements (GSPRs). The technical documentation must fulfil requirements under Annex II and III of the EU MDR 2017/745 for medical devices. In case of IVDs, the technical documentation must fulfil requirements as per Annex II and III of the IVDR 2017/746.

Technical documentation must include a complete description of the device, intended use, risk classification rationale, design and manufacturing information, labeling, and instructions for use. It must also contain essential verification and validation evidence, such as biocompatibility testing, software validation (if applicable), and results from clinical evaluations for medical devices, performance evaluations for IVDs. Documentation should also include PMS plans and reports, as well as clinical investigations where necessary. For higher-risk devices, a Summary of Safety and Clinical Performance (SSCP) is also required.

The technical file must be structured, traceable, and readily accessible for review by Notified Bodies and competent authorities. The technical file must also reference any applicable harmonized standards or common specifications used to demonstrate conformity. For example, if the device includes embedded software, the file should reference IEC 62304 compliance and provide traceability to risk controls mitigating software failure.

6. Implement a Supplier Management System

Manufacturers must implement a documented supplier management system to evaluate, qualify, and monitor external suppliers whose deliverables impact device quality, safety, or regulatory conformity.

The supplier management process includes defining risk-based selection criteria (product criticality, compliance history), performing initial and periodic evaluations (supplier audits, QMS certifications). The supplier management process also involves establishing written quality agreements specifying roles, responsibilities, and regulatory requirements that need to be fulfilled by suppliers. The supplier’s performance must be continuously monitored using metrics such as nonconformance trends, on-time delivery, and supplier audit outcomes. Supplier issues must follow a defined and documented escalation path. These escalation paths include establishing a Supplier Corrective Action Report (SCAR), supplier requalification, or removal from the Approved Supplier List (ASL) where necessary. 

A change in a contract manufacturer, particularly for critical manufacturing steps, may constitute a significant change under EU MDR 2017/745 and EU IVDR 2017/746. Such changes require a formal impact assessment, potential notified body review, and updates to technical documentation where necessary.

7. Conduct a Clinical Evaluation (or Performance Evaluation for IVDs)

Manufacturers of medical devices and IVDs must demonstrate that their products meet applicable safety, performance, and clinical benefit requirements. These requirements must be met through a structured evaluation process. This is required as per Annex XIV and Article 61 under EU MDR 2017/745 and Annex XIII and Article 56 under EU IVDR 2017/746.

For medical devices, this involves conducting a Clinical Evaluation to assess whether the device achieves its intended clinical benefits and maintains an acceptable benefit-risk profile. The process includes a systematic literature review, appraisal of clinical investigations, and evaluation of equivalent devices, if an equivalent device is available.

Class III and implantable devices require clinical investigations unless sufficient clinical evidence is available from an equivalent device. The manufacturer must have full access to the technical and clinical data of the equivalent device.

For IVDs, a Performance Evaluation must be conducted per IVDR Annex XIII requirements listed below.

• Scientific validity of the analyte–disease association,
• Analytical performance (such as sensitivity, specificity, reproducibility),
• Clinical performance, demonstrated through Performance Studies or published peer-reviewed literature.

Manufacturers must document the results in a Clinical Evaluation Report (CER) for medical devices or a Performance Evaluation Report (PER) for IVDs. These reports must be included in the technical documentation and regularly updated through post-market follow-up activities (PMCF for medical devices, PMPF for IVDs). CERs and PERs must be scientifically justified, aligned with the intended use, and included in the technical documentation. The PRRC is responsible for ensuring these evaluations are properly conducted and documented in accordance with MDR/IVDR. Notified Bodies will assess these reports during the conformity assessment to ensure compliance with the General Safety and Performance Requirements (GSPRs) and that the device’s benefit-risk profile remains acceptable.

8. Assign an Authorized Representative

Non-EU manufacturers placing medical devices or IVDs on the EU market must appoint an authorized representative in accordance with EU MDR 2017/745 Article 11 and EU IVDR 2017/746 Article 11.

The authorized representative acts as the legal liaison between the manufacturer and EU Competent Authorities. The authorized representative is responsible for verifying that the device’s Declaration of Conformity and Technical Documentation have been drawn up and that appropriate conformity assessment procedures have been carried out. They must ensure access to post-market surveillance and vigilance documentation, and are legally required to cooperate with authorities in incident investigations or compliance issues.

The relationship between the manufacturer and the authorized representative must be formalized in a written agreement that clearly outlines regulatory responsibilities, including UDI compliance, registration in EUDAMED, access to technical documentation, and incident reporting.

As per MDR Annex I, Section 23.2(d), and IVDR Annex I, Section 20.2(d), if the manufacturer has a registered place of business outside the EU, the label must include the name of the authorized representative and address of the registered place of business of the authorized representative.

Failure to appoint a compliant Authorized Representative may result in denial of market access, regulatory enforcement, or product withdrawal.

9. Obtain CE Certification by a Notified Body

For Class I (measuring/sterile/reusable), Class IIa, IIb, and III medical devices, and for Class A (Sterile), B, C, and D IVDs, CE certification must be obtained through a designated Notified Body (NB) under EU MDR 2017/745 or IVDR 2017/746.

The Notified Body is a third-party organization authorized by an EU member state and listed in the NANDO database to perform conformity assessments. The manufacturer must submit a complete technical documentation package and QMS evidence. This could include ISO 13485:2016 certification, and results from clinical evaluation or performance evaluation as applicable.

The NB conducts a conformity assessment, which may include audits of the manufacturer’s QMS, review of technical documentation, and evaluation of clinical or performance data. The scope and depth of the assessment depend on the device classification and the selected conformity assessment route. For Class Is, Im, and Ir devices under MDR, and Class A sterile IVDs, under IVDR, Notified Body involvement is limited to assessment of the specific regulated characteristic (e.g., sterility, measuring function, or reusability), not the full technical file.

Upon successful assessment, the Notified Body issues a CE certificate. This allows the manufacturer to draw up the EU Declaration of Conformity and affix the CE mark.

As per Article 20(5) of the EU MDR 2017/745, the CE marking must be followed by the identification number of the Notified Body responsible for the conformity assessment procedures outlined in Article 52, where applicable. Similarly, Article 18(5) of EU IVDR 2017/746 requires that the Notified Body number appear alongside the CE mark for IVDs assessed under the procedures in Article 48.

Failure to obtain or maintain a valid NB certification prohibits lawful placement of the device on the EU market.

10. Draw Up the EU Declaration of Conformity (DoC)

Once the conformity assessment has been successfully completed, manufacturers must draw up an EU DoC in accordance with Annex IV of the EU MDR 2017/745 or IVDR 2017/746.

The Declaration of Conformity is a legally binding document in which the manufacturer declares that the device meets all applicable general safety and performance requirements (GSPRs) and complies with the relevant EU legislation. It must include the manufacturer’s details, authorized representative (if applicable), device identification (including Basic UDI-DI), risk class of device, applicable regulations, conformity assessment route, and reference to the Notified Body certificate where required.

The DoC must be signed by an authorized person within the organization, for example, the PRRC, and retained as part of the technical documentation. It must be made available to Competent Authorities upon request and is a prerequisite for affixing the CE marking to the device.

Market access may be delayed if the Declaration of Conformity is incomplete or not compliant.

11. Register Your Device Under a Unique Device Identifier (UDI)

Under Article 27 and Annex VI of EU MDR 2017/745 and Article 24 and Annex VI of EU IVDR 2017/746, manufacturers are required to assign and register a Unique Device Identifier (UDI) to each device before it is placed on the EU market. The UDI system ensures traceability, post-market surveillance, and regulatory transparency throughout the device lifecycle.

This image illustrates the placement and structure of a UDI on a medical device label, including both human-readable and machine-readable formats.

Each UDI consists of two parts that are listed below.

• UDI-DI (Device Identifier): A fixed portion that identifies the device model and manufacturer.
• UDI-PI (Production Identifier): A variable portion that includes production-related data such as lot number, serial number, and expiration date.

Manufacturers must also assign a Basic UDI-DI. This is referenced in the Declaration of Conformity and used as the main identifier in EUDAMED and for Notified Body certificates.

 The regulatory requirements UDI must fulfil are listed below.

• Applied on the label and packaging of the device.
• Submitted to EUDAMED along with other registration data (once the database is fully functional).
• Used consistently across all technical documentation, certificates, and post-market activities.

Failure to assign and register a UDI correctly under MDR/IVDR may delay CE marking or release of the device to the EU market.

12. Affix a CE Marking to the Medical Device

After all applicable conformity assessment procedures are completed, a Declaration of Conformity is signed. Followed by this, the manufacturer must affix the CE marking to the medical device in accordance with Article 20 under EU MDR 2017/745 and Article 18 under IVDR 2017/746.

The primary requirements CE marking must follow are listed below.

• Be affixed visibly, legibly, and indelibly to the device or its sterile packaging, and to the instructions for use (IFU) and outer packaging, where applicable.
• Include the four-digit identification number of the Notified Body if one was involved in the conformity assessment ( for Class IIa, IIb, III, or Class B–D IVDs).
• Be affixed before the device is placed on the EU market.

Affixing the CE mark confirms that the device complies with all applicable General Safety and Performance Requirements (Annex I of MDR/IVDR) and that all conformity assessment obligations have been fulfilled.

Improper or premature application of the CE mark constitutes a regulatory violation and may trigger enforcement actions such as product withdrawals.

13. Submit Device and UDI Registration in the EUDAMED

Manufacturers must register their medical devices and associated Unique Device Identifiers (UDIs) in the European Database on Medical Devices (EUDAMED) once the relevant modules become mandatory. Registration of device and economic operator information in EUDAMED ensures regulatory transparency, facilitates market surveillance, and supports traceability across the EU medical device market as required under Article 33 of EU MDR 2017/745 and Article 30 of IVDR 2017/746. As of 2025, the Actor, UDI/Device, and Notified Body/Certificate modules are functional on a voluntary basis.

Steps manufacturers could take to ensure EUDAMED readiness are listed below.

1. Obtain a Single Registration Number (SRN) through the Actor module.
2. Enter Basic UDI-DI and UDI-DI data in the UDI/Device module in accordance with EU MDR 2017/745 and IVDR 2017/746 Annex VI.
3. Maintain all submitted records in a traceable and version-controlled format within the QMS.

While full EUDAMED implementation is anticipated by 2027, early registration demonstrates regulatory maturity, facilitates smoother conformity assessments, and supports compliance with post-market surveillance requirements.

14. Maintain a Post-Market Surveillance (PMS) System

Manufacturers are required under Article 83 of EU MDR 2017/745, and Article 78 of IVDR 2017/746 to establish and maintain a systematic, proactive, and documented PMS system as part of their Quality Management System. The PMS system must continuously collect, analyze, and assess post-market data to confirm the safety, performance, and benefit-risk profile of the device throughout its lifecycle.

The PMS system must include procedures for monitoring adverse events, reviewing clinical experience, analyzing trends in complaints and nonconformities, and incorporating findings from vigilance activities. This includes Field Safety Corrective Actions (FSCAs) and Serious Incident Reports. Outputs from the PMS system feed into risk management (ISO 14971), technical documentation, and clinical evaluation updates.

For Class I medical devices under the EU MDR, manufacturers must prepare and maintain a Post-Market Surveillance Report (PMSR). For Class IIa, IIb, and III devices, a Periodic Safety Update Report (PSUR) is required, which must be updated at defined intervals and submitted to the Notified Body, where applicable. Under the IVDR, Class A and B in vitro diagnostic devices require a PMSR, while Class C and D devices require a PSUR. PSURs must summarize PMS findings, CAPAs, trend data, and the device’s updated benefit-risk determination, supporting continued conformity with the General Safety and Performance Requirements (GSPRs) A compliant PMS system enables early detection of emerging risks, supports regulatory reporting under Article 87 of the EU MDR 2017/745 and Article 82 of the EU IVDR 2017/746, and provides objective evidence of continued conformity.

How Long Does It Take to Obtain CE Marking for Medical Devices?

The time required to obtain CE marking for a medical device can range from 3 months to over 24 months, depending on the device classification, regulatory pathway, and preparedness of the manufacturer. These estimates reflect industry benchmarks and general experience from Notified Bodies and medical device manufacturers under MDR 2017/745 and IVDR 2017/746.

For Class I medical devices that are non-sterile, non-measuring, non-reusable surgical instruments, and for Class A IVD devices that are non-sterile, the CE mark can be self-declared by the manufacturer after completing internal conformity assessment procedures and compiling the required technical documentation in accordance with EU MDR/IVDR. This process typically takes approximately 3 to 6 months, assuming the documentation and Quality Management System (QMS) are already in place and conform to ISO 13485 requirements.

For Class Is, Im, Ir, IIa, IIb, and III devices, as well as IVD Class A (Sterile), B, C, and D devices, CE marking requires involvement of a Notified Body, significantly increasing the timeline. CE marking for higher-risk medical devices and IVDs, such as Class III and Class D, commonly takes 18–24 months or more. These timelines are not absolute but are indicative of current industry experience, and they may vary depending on specific product characteristics, regulatory pathway, and Notified Body engagement timelines.

The key factors that affect the CE marking timeline are listed below.

• Device Classification and Risk: Higher classes require more rigorous conformity assessments and Notified Body audits.
• Completeness of Technical Documentation: Inadequate Design Dossiers, risk management files, clinical evaluation reports (CERs), or performance evaluation reports (PERs) lead to delays.
• Need for Clinical Investigations: Additional time must be factored in for trial design, execution, and reporting, if existing clinical data are insufficient.
• Availability and Capacity of the Notified Body: Many Notified Bodies experience long lead times, especially post-MDR/IVDR implementation.
• Manufacturer’s QMS Maturity: A fully implemented and ISO 13485-certified QMS significantly accelerates the review process.

While low-risk Class I and Class A devices may achieve CE marking in a few months through self-certification, higher-risk devices such as Class III medical devices or Class D IVDs typically require significant Notified Body interaction and in-depth review of clinical and performance data. For these devices, the CE marking process may take 18 to 24 months or longer. Actual timelines can vary significantly, depending on the complexity of the device, completeness of documentation, and the capacity of the designated Notified Body.

How Long Is a CE Certificate Valid?

A CE certificate issued by a Notified Body under the EU MDR 2017/745 or IVDR 2017/746 is valid for a maximum of five years from the date of issuance, regardless of the device classification or conformity assessment route.

The validity period does not vary by device class. However, ongoing compliance must be demonstrated through annual surveillance audits and continued adherence to all regulatory requirements. This includes PMS, vigilance reporting, and maintaining an effective and compliant Quality Management System (QMS).

To maintain certificate validity, manufacturers must do the following.

• Undergo periodic surveillance audits by the Notified Body.
• Maintain up-to-date, compliant Technical Documentation and QMS records.
• Implement and document PMS activities, including post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF), as applicable.
• Notify the Notified Body of significant changes to the device, intended use, manufacturing processes, or quality system elements.

Renewal of a CE certificate requires a full re-certification audit, which must be initiated before the expiration of the existing certificate. This involves a complete reassessment of the QMS and conformity of the device(s), including evaluation of updated technical documentation, clinical or performance evidence, and regulatory files.

Premature invalidation or suspension of a CE certificate in case the following events occur.

• The manufacturer fails to comply with regulatory or contractual obligations.
• Major nonconformities are identified and not resolved within specified timelines.
• There is a failure to maintain QMS effectiveness or address critical PMS findings.
• The manufacturer discontinues communication or collaboration with the Notified Body.

How Does Medical Device QMS Software Streamline the CE Marking Certification Process?

Medical device QMS software can significantly streamline the CE marking certification process by providing fully traceable, auditable workflows that help ensure regulatory compliance at every stage. This includes design documentation, technical file assembly, and CAPA management in alignment with EU MDR 2017/745 and EU IVDR 2017/746 requirements.

A digital QMS ensures that every process is executed within a validated environment, significantly reducing compliance risk and audit deficiencies.

Medical device eQMS platforms, such as SimplerQMS, streamline workflows to support core CE marking activities, including risk management, design and development traceability, supplier controls, and post-market surveillance activities. The eQMS system also ensures that all technical documentation required under MDR and IVDR Annexes II and III is version-controlled, searchable, and securely maintained.

SimplerQMS provides a medical device QMS software purpose-built for medical device and other life science companies. SimplerQMS supports a wide range of interconnected QMS processes, including change control, document control, CAPA, training, audits, and other QMS processes within a single validated system. It supports compliance with ISO 13485:2016, MDR/IVDR, and complies with computer system validation requirements per ISO 13485 and 21 CFR 820.

By supporting role-based access, time-stamped audit trails, and Part 11/Annex 11-compliant electronic signatures, SimplerQMS makes every step in the CE certification process traceable. This helps manufacturers remain prepared for regulatory submissions and CE certification audits.

SimplerQMS is validated according to GAMP 5 and reduces the validation burden while maintaining compliance with computer system validation requirements as per ISO 13485 and 21 CFR 820.