CE Marking Strategy for Medical Devices & IVD
We've guided hundreds of manufacturers to obtain CE marking.
CE Marking Strategy for Medical Devices and IVD under MDR & IVDR
CE Marking Strategy for Medical Devices and IVD under MDR & IVDR
CE marking is mandatory for placing medical devices and in vitro diagnostic devices (IVDs) on the European market. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), manufacturers must follow a clearly defined regulatory pathway to demonstrate conformity, safety, and performance.
Qserve guides manufacturers worldwide in obtaining CE marking under MDR and IVDR requirements.
What is a CE marking strategy?
CE marking stands for Conformité Européenne (“European Conformity”). It is a mandatory conformity mark for certain products sold within the European Economic Area (EEA). By affixing a CE mark, the manufacturer declares that the product meets all applicable EU health, safety, and environmental requirements under relevant directives and regulations. This allows the product to be marketed freely across the EU/EEA without additional national approvals. It is not a quality mark or an indication of origin; it simply signals compliance with EU rules.
CE marking is required only for products covered by harmonized EU legislation that explicitly mandates it. If no such directive applies, the product must not carry the CE mark. It is illegal to affix CE marking to products outside the scope of these regulations.
Medical devices and in vitro diagnostic devices (Medical Device Regulation, IVDR) require a CE mark before placing on the EU market.
Achieving CE marking involves more than passing a single test. Manufacturers must establish robust technical documentation, perform appropriate clinical or performance evaluations, implement a compliant quality management system, and ensure that labeling, usability, and post-market obligations are fully addressed.
Because devices and IVDs vary widely in technology, risk class, and intended use, the path to CE marking differs for every product. Manufacturers must determine the correct classification, identify the appropriate conformity assessment procedure, and prepare documentation aligned with the expectations of Notified Bodies and competent authorities.
A clear regulatory strategy from the beginning of development helps avoid delays, ensures requirements are understood early, and supports a smooth and predictable route to European market access.
Why CE marking is challenging & How we help
Achieving CE marking under the EU Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR) nowadays requires far more than previously under the old MDD and IVDD directives. It demands robust quality management systems covering the MDR and IVDR requirements for design, production, and post-market monitoring; comprehensive technical documentation; and rigorous clinical or performance data.
Too many manufacturers discover, often late in the conformity assessment process, that their technical documentation does not cover all regulatory requirements, or their clinical evidence is insufficient. The result is a lengthy conformity assessment, unnecessary Notified Body review rounds, iterations at high costs, and postponed market access. We provide end-to-end CE marking guidance: from regulatory classification and strategy development through technical file compilation. We can act as your Notified Body liaison when needed and help solve non-conformities during the review process. Our deep expertise in MDR and IVDR ensures your submission documentation covers the requirements, and the timelines of the conformity assessment process and time to market are minimized.
Satisfied Clients
Our Core CE Marking Services:
Regulatory Strategy & Classification
We determine whether your product qualifies as a medical device or IVD, establish its correct MDR/IVDR classification, and define the conformity assessment route that aligns with your business objectives.
Notified Body Engagement & Submission Support
We assist in selecting and engaging an appropriate Notified Body, preparing submission files, managing queries and responses, and ensuring audit readiness to secure your ISO 13485 and CE certificates.
Technical Documentation Preparation
We develop or review your submission file to meet MDR Annex II/III (or IVDR module) requirements, to ensure completeness, facilitating a smooth review process.
Post-Market Surveillance and Post market Clinical Follow-Up
We establish or enhance your PMS/PMCF (or IVDR performance follow-up) programs for legacy devices. Our experts provide comprehensive support in designing and executing PMCF surveys, ensuring high-quality data collection and analysis to meet regulatory requirements.
Clinical Trials – CRO
When appropriate, we conduct full-scope clinical studies, pre- and post-market, across a variety of therapeutic areas. As a leading contract research organization, we specialize in providing comprehensive services supporting the successful design, development, execution, and management of clinical trials.
Step-by-step CE Marking process
Step 1: Confirm the Regulatory Pathway
Determine whether your product is a medical device under MDR or an IVD under IVDR and apply the correct classification rules. MDR classes include Class I (Is, Im, Ir), IIa, IIb, and III. IVDR classes include Class A (sterile or non-sterile), B, C, and D. The impact of classification is significant, as a higher class means more regulatory controls. Notified Body involvement is required for all courses except medical device Class I and IVD Class I
Step 2: Set Up a Quality Management System (QMS)
A QMS is required for all devices except non-sterile Class I medical devices and Class A IVDs. Most manufacturers follow ISO 13485:2016 as the standard for quality management systems, and additional MDR and IVDR requirements must be included in the QMS.
Step 3: Conduct Risk Management (ISO 14971)
The risk management file for the device or IVD must include a risk management plan, hazard identification, risk estimation, harm evaluation, risk control and verification, benefit–risk analysis, and a risk management report.
Step 4: Generate Technical Documentation
The CE submission file must cover the content of Annex II of the MDR or IVDR. This includes a device description with specifications and intended purpose, device classification rationale, design and manufacturing information, risk management documentation, a General Safety and Performance Requirements checklist, performance characteristics, software documentation where applicable following IEC 62304, biocompatibility, electrical safety and sterilization validation, clinical evaluation for MDR or performance evaluation for IVDR, labeling, IFU and UDI, a post-market surveillance plan including PMCF or PMPF plans and reports, and a draft Declaration of Conformity.
Step 5: Select and Engage a Notified Body
This is a critical step and often the longest lead-time activity for higher class MDR and IVDR devices. A Notified Body is required for all MDR devices except non-sterile Class I and for all IVDR devices except non-sterile Class A.
5.1 Identify Candidate Notified Bodies
When identifying candidates, check their designation scope under MDR or IVDR and the device codes or technologies they cover, their experience with your device type, available capacity and waiting times, fees and contract structure, and global reputation and communication style. Many manufacturers shortlist two to three Notified Bodies due to limited availability.
5.2 Submit a Pre-Application or Request for Quotation
You typically provide a device description and intended purpose, risk class and rationale, expected conformity assessment route, QMS status, company details, and a high-level overview of the availability of technical documentation. For IVDR, the performance evaluation approach is also provided. The Notified Body confirms whether they can accept the product, provides timelines and pricing, and assigns the appropriate product codes.
5.3 Select Your Notified Body
Selection is based on timelines, price, experience with similar technologies, responsiveness, and, optionally, geographical convenience. Once confirmed, you proceed to the formal application.
Step 6: Application and Contract Phase
6.1 Formal Application for CE and ISO 13485 Certification
You submit a formal application form, device information including UDI-DI, intended purpose and classification, identification of the conformity assessment route, confirmation of QMS readiness, and a preliminary list of technical documentation. The Notified Body looks over the submission for completeness and confirms its acceptance. If ISO 13485 certification is not yet in place, the QMS manual and mandatory procedures are submitted, and an audit application is filed, which may be combined with the MDR or IVDR audit. If ISO 13485 certification already exists, the certificate is provided, and additional MDR or IVDR QMS elements are reviewed.
6.2 Formal Proposal and Contracting Phase
The Notified Body issues a formal service proposal including work packages, timelines, and assessment plans, along with a contract or certification agreement. You must sign the CE marking certification agreement, the ISO 13485 certification agreement if applicable, confidentiality and financial terms, and the Notified Body’s general terms and conditions. No technical documentation review or audit planning begins before the contract is signed.
Step 7: Notified Body Review and Certification Phase
After the contract is signed, the technical documentation review is scheduled. The Notified Body selects representative devices from the manufacturer’s portfolio and performs focused technical documentation reviews, typically in three rounds. Audits are expected near the end of the evaluation to assess compliance with MDR, IVDR, and ISO 13485. Once all reviews and audits are completed, the Notified Body’s certification board issues CE certificates. This phase may take between 9 and 24 months, depending on the class and the Notified Body.
Step 8: Prepare for UDI and EUDAMED Registration
Apply for an SRN as a manufacturer, appoint an EU importer and an authorised representative if located outside the EU, assign UDI-DI and UDI-PI, and upload relevant actor, device, and certificate data into EUDAMED, depending on module availability.
Step 9: Finalize and Sign the EU Declaration of Conformity
The EU Declaration of Conformity is a mandatory legal document in which the manufacturer or authorized representative declares compliance with applicable EU legislation. It is issued after completion of the conformity assessment and compilation of the technical documentation. The DoC includes manufacturer information, device identification, and risk class, conformity to MDR or IVDR and GSPRs, applied standards and common specifications, the Notified Body name and number if applicable, and a description of the conformity assessment procedure.
Step 10: Affix CE Marking
The CE mark and, if applicable, the Notified Body number must be affixed to the device, packaging, and IFU before placing the device on the market.
Step 11: Post-Market Obligations
Post-market activities are continuous and essential for compliance. These include a PMS plan and PMS report for Class I medical devices, PSURs for Class IIa, IIb, and III medical devices, and Class C and D IVDs, vigilance reporting of serious incidents, trend reporting, and PMCF or PMPF activities.
Step-by-step CE Marking process
Step 1: Confirm the Regulatory Pathway
Determine whether your product is a medical device under MDR or an IVD under IVDR and apply the correct classification rules. MDR classes include Class I (Is, Im, Ir), IIa, IIb, and III. IVDR classes include Class A (sterile or non-sterile), B, C, and D. The impact of classification is significant, as a higher class means more regulatory controls. Notified Body involvement is required for all courses except medical device Class I and IVD Class I
Step 2: Set Up a Quality Management System (QMS)
A QMS is required for all devices except non-sterile Class I medical devices and Class A IVDs. Most manufacturers follow ISO 13485:2016 as the standard for quality management systems, and additional MDR and IVDR requirements must be included in the QMS.
Step 3: Conduct Risk Management (ISO 14971)
The risk management file for the device or IVD must include a risk management plan, hazard identification, risk estimation, harm evaluation, risk control and verification, benefit–risk analysis, and a risk management report.
Step 4: Generate Technical Documentation
The CE submission file must cover the content of Annex II of the MDR or IVDR. This includes a device description with specifications and intended purpose, device classification rationale, design and manufacturing information, risk management documentation, a General Safety and Performance Requirements checklist, performance characteristics, software documentation where applicable following IEC 62304, biocompatibility, electrical safety and sterilization validation, clinical evaluation for MDR or performance evaluation for IVDR, labeling, IFU and UDI, a post-market surveillance plan including PMCF or PMPF plans and reports, and a draft Declaration of Conformity.
Step 5: Select and Engage a Notified Body
This is a critical step and often the longest lead-time activity for higher class MDR and IVDR devices. A Notified Body is required for all MDR devices except non-sterile Class I and for all IVDR devices except non-sterile Class A.
5.1 Identify Candidate Notified Bodies
When identifying candidates, check their designation scope under MDR or IVDR and the device codes or technologies they cover, their experience with your device type, available capacity and waiting times, fees and contract structure, and global reputation and communication style. Many manufacturers shortlist two to three Notified Bodies due to limited availability.
5.2 Submit a Pre-Application or Request for Quotation
You typically provide a device description and intended purpose, risk class and rationale, expected conformity assessment route, QMS status, company details, and a high-level overview of the availability of technical documentation. For IVDR, the performance evaluation approach is also provided. The Notified Body confirms whether they can accept the product, provides timelines and pricing, and assigns the appropriate product codes.
5.3 Select Your Notified Body
Selection is based on timelines, price, experience with similar technologies, responsiveness, and, optionally, geographical convenience. Once confirmed, you proceed to the formal application.
Step 6: Application and Contract Phase
6.1 Formal Application for CE and ISO 13485 Certification
You submit a formal application form, device information including UDI-DI, intended purpose and classification, identification of the conformity assessment route, confirmation of QMS readiness, and a preliminary list of technical documentation. The Notified Body looks over the submission for completeness and confirms its acceptance. If ISO 13485 certification is not yet in place, the QMS manual and mandatory procedures are submitted, and an audit application is filed, which may be combined with the MDR or IVDR audit. If ISO 13485 certification already exists, the certificate is provided, and additional MDR or IVDR QMS elements are reviewed.
6.2 Formal Proposal and Contracting Phase
The Notified Body issues a formal service proposal including work packages, timelines, and assessment plans, along with a contract or certification agreement. You must sign the CE marking certification agreement, the ISO 13485 certification agreement if applicable, confidentiality and financial terms, and the Notified Body’s general terms and conditions. No technical documentation review or audit planning begins before the contract is signed.
Step 7: Notified Body Review and Certification Phase
After the contract is signed, the technical documentation review is scheduled. The Notified Body selects representative devices from the manufacturer’s portfolio and performs focused technical documentation reviews, typically in three rounds. Audits are expected near the end of the evaluation to assess compliance with MDR, IVDR, and ISO 13485. Once all reviews and audits are completed, the Notified Body’s certification board issues CE certificates. This phase may take between 9 and 24 months, depending on the class and the Notified Body.
Step 8: Prepare for UDI and EUDAMED Registration
Apply for an SRN as a manufacturer, appoint an EU importer and an authorised representative if located outside the EU, assign UDI-DI and UDI-PI, and upload relevant actor, device, and certificate data into EUDAMED, depending on module availability.
Step 9: Finalize and Sign the EU Declaration of Conformity
The EU Declaration of Conformity is a mandatory legal document in which the manufacturer or authorized representative declares compliance with applicable EU legislation. It is issued after completion of the conformity assessment and compilation of the technical documentation. The DoC includes manufacturer information, device identification, and risk class, conformity to MDR or IVDR and GSPRs, applied standards and common specifications, the Notified Body name and number if applicable, and a description of the conformity assessment procedure.
Step 10: Affix CE Marking
The CE mark and, if applicable, the Notified Body number must be affixed to the device, packaging, and IFU before placing the device on the market.
Step 11: Post-Market Obligations
Post-market activities are continuous and essential for compliance. These include a PMS plan and PMS report for Class I medical devices, PSURs for Class IIa, IIb, and III medical devices, and Class C and D IVDs, vigilance reporting of serious incidents, trend reporting, and PMCF or PMPF activities.
Common Challenges in CE Marking Strategy
Common Challenges in CE Marking Strategy
Many manufacturers underestimate the complexity of defining a CE marking strategy under MDR or IVDR. Common issues include misinterpreting regulatory requirements, generating insufficient clinical or performance evidence, and encountering delays due to limited Notified Body capacity. These challenges are often compounded by incomplete or inconsistent technical documentation and unclear transition plans from MDD or IVDD.
Identifying and addressing these risks early, before regulatory activities begin in earnest, helps shorten approval timelines, improves predictability, and reduces regulatory uncertainty.
How Qserve Supports Your CE Marking Strategy
Qserve provides end-to-end regulatory support for medical devices and IVDs, including:
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CE marking strategy development
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MDR and IVDR classification support
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Conformity assessment route definition
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Notified Body interaction and preparation
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Technical documentation development and review
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Clinical and performance evaluation support
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Post-market surveillance and PMCF/PMPF planning
Our regulatory experts work closely with manufacturers to align regulatory strategy with product development and commercialization goals.
Couldn't find your question?
What exactly is CE marking under MDR/IVDR?
CE marking certifies that your medical device or IVD meets all applicable EU safety, performance, and regulatory requirements, authorizing its sale throughout the European Economic Area.
How do I determine the correct classification and pathway for my device?
Classification depends on risk level, intended use, and device functionality. Our experts conduct this analysis and identify the appropriate conformity assessment route.
Why is a Notified Body required, and how long does the process take?
Apart from Class I Medical devices and non-sterile Class A IVDs, higher-risk devices and IVDs require the involvement of a Notified Body. Timelines vary by device class and complexity; however, well-prepared submissions can significantly reduce the time to certification.
What happens after I receive my CE mark?
CE marking initiates ongoing obligations: post-market surveillance, vigilance reporting, device registration, and periodic recertification. Maintaining these requirements is essential for continued market access.