CE Marking for Medical Devices & IVD
CE Marking for Medical Devices and IVD under MDR & IVDR
CE Marking for Medical Devices and IVD under MDR & IVDR
CE marking is mandatory for placing medical devices and in vitro diagnostics (IVDs) on the European market. Under the EU Medical Device Regulation (MDR) and the 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 Mark?
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 the relevant directives and regulations, allowing it to be marketed freely across the EU/EEA without additional national approvals. It is not a quality mark or an indication of origin; it signals compliance with EU rules, nothing more.
CE marking is required only for products covered by harmonized EU legislation that explicitly mandates it. If no such legislation applies, the product must not carry the CE mark. Affixing it outside the scope of these regulations is illegal.
Medical devices and in vitro diagnostics (IVDs) both require a CE mark before placing the product on the EU market.
Building a Strong Regulatory Strategy for CE Marking
Achieving CE marking involves more than passing a single test. Manufacturers must establish robust technical documentation, perform appropriate performance or clinical evaluations implement a compliant quality management system, and make sure 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 start of development helps avoid delays, ensures requirements are understood early, and supports a smooth, predictable route to European market access.
Why CE Marking for Medical Devices & IVDs Is Challenging, and How We Help
CE marking under EU MDR or IVDR demands far more than it did under the old MDD and IVDD directives: robust quality management systems covering 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 doesn't cover all regulatory requirements, or their clinical evidence falls short. The result is a lengthy assessment, unnecessary Notified Body review rounds, costly iterations, and postponed market access. We provide end-to-end CE marking guidance, from regulatory classification and strategy development through technical file compilation, act as your Notified Body liaison when needed, and help resolve non-conformities during review. Our depth in MDR and IVDR keeps your submission documentation on target and your conformity assessment timeline as short as it can be.
Check Your Own Readiness
Not sure where your own submission stands against these eleven steps? Our CE Submission Readiness Check walks through the same gates covered above, classification, QMS alignment, technical documentation, clinical or performance evidence, Notified Body engagement, post-market surveillance, and UDI/EUDAMED registration, and gives you a readiness score in about five minutes.
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.
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- Medical Devicesarrow_right_alt
- Combination Devicesarrow_right_alt
- In Vitro Diagnostics (IVD)arrow_right_alt
- Companion Diagnostics (CDx)arrow_right_alt
- Contract Research Organization (CRO)arrow_right_alt
- Global Market Accessarrow_right_alt
- AI Regulatory Supportarrow_right_alt
- Mergers & Acquisitionsarrow_right_alt
- Start-Upsarrow_right_alt
Step-by-Step CE Marking Process for Medical Devices & IVDs
Step 1: Confirm the Regulatory Pathway
Determine whether your product is a medical device under MDR or an IVD under IVDR, then apply the correct classification rules. MDR classes run from Class I (Is, Im, Ir) through IIa, IIb, and III; IVDR classes run from Class A (sterile or non-sterile) through B, C, and D. Classification has real consequences: a higher class means more regulatory controls, and Notified Body involvement is required for every class except medical device Class I and IVD Class A.
Step 2: Set Up a Quality Management System (QMS)
A QMS is required for every device except non-sterile Class I medical devices and Class A IVDs. Most manufacturers build theirs on ISO 13485:2016, with the additional MDR and IVDR-specific requirements layered in.
Step 3: Conduct Risk Management (ISO 14971)
The risk management file must include a risk management plan, hazard identification, risk estimation, harm evaluation, risk control and verification, a benefit-risk analysis, and a risk management report.
Step 4: Generate Technical Documentation
The CE submission file must cover Annex II of the MDR or IVDR: a device description with specifications and intended purpose, the classification rationale, design and manufacturing information, risk management documentation, a General Safety and Performance Requirements checklist, performance characteristics, software documentation under IEC 62304 where applicable, 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 often the longest lead-time activity for higher-class MDR and IVDR devices. It's required for every MDR device except non-sterile Class I, and every IVDR device except non-sterile Class A.
Identify candidate Notified Bodies.
Check their designation scope under MDR or IVDR, the device codes or technologies they cover, experience with your device type, capacity and waiting times, fees and contract structure, and reputation. Many manufacturers shortlist two to three Notified Bodies, given how limited availability has become.
Submit a pre-application or request for quotation.
This typically includes a device description and intended purpose, risk class and rationale, the expected conformity assessment route, QMS status, company details, and a high-level view of your technical documentation's availability, plus, for IVDR, your performance evaluation approach. The Notified Body confirms whether it can accept the product, provides timelines and pricing, and assigns product codes.
Select your Notified Body.
Base the decision on timelines, price, experience with similar technologies, responsiveness, and, optionally, geographic convenience, then proceed to formal application.
Step 6: Application and Contract Phase
Formal application for CE and ISO 13485 certification.
Submit a formal application, device information including UDI-DI, intended purpose and classification, the conformity assessment route, confirmation of QMS readiness, and a preliminary list of technical documentation. The Notified Body checks the submission for completeness. If ISO 13485 certification isn't yet in place, the QMS manual and mandatory procedures go in alongside an audit application, which can be combined with the MDR or IVDR audit; if certification already exists, the certificate is provided and the additional MDR or IVDR QMS elements are reviewed instead.
Formal proposal and contracting.
The Notified Body issues a service proposal covering work packages, timelines, and assessment plans, plus a contract or certification agreement. You sign the CE marking certification agreement, the ISO 13485 agreement if applicable, confidentiality and financial terms, and the Notified Body's general terms. No documentation review or audit planning starts before the contract is signed.
Step 7: Notified Body Review and Certification Phase
Once the contract is signed, the technical documentation review is scheduled. The Notified Body selects representative devices from your portfolio and runs focused reviews, typically across three rounds, with audits expected near the end to check compliance with MDR, IVDR, and ISO 13485. Once reviews and audits are complete, the Notified Body's certification board issues your CE certificates. This phase typically takes 9 to 24 months, depending on device class and 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 you're located outside the EU, assign UDI-DI and UDI-PI codes, and upload the relevant actor, device, and certificate data into EUDAMED as modules become available.
Step 9: Finalize and Sign the EU Declaration of Conformity
The EU Declaration of Conformity is the legal document in which the manufacturer or authorized representative declares compliance with applicable EU legislation, issued once the conformity assessment and technical documentation are complete. It covers manufacturer information, device identification and risk class, conformity to MDR or IVDR and the GSPRs, applied standards and common specifications, the Notified Body's name and number where applicable, and the conformity assessment procedure used.
Step 10: Affix CE Marking
The CE mark, and the Notified Body number where applicable, must appear on the device, its packaging, and the IFU before the device goes on the market.
Step 11: Post-Market Obligations
Post-market activity is continuous, not a one-time filing. It includes a PMS plan and report for Class I medical devices, PSURs for Class IIa, IIb, and III 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 for Medical Devices & IVDs
Step 1: Confirm the Regulatory Pathway
Determine whether your product is a medical device under MDR or an IVD under IVDR, then apply the correct classification rules. MDR classes run from Class I (Is, Im, Ir) through IIa, IIb, and III; IVDR classes run from Class A (sterile or non-sterile) through B, C, and D. Classification has real consequences: a higher class means more regulatory controls, and Notified Body involvement is required for every class except medical device Class I and IVD Class A.
Step 2: Set Up a Quality Management System (QMS)
A QMS is required for every device except non-sterile Class I medical devices and Class A IVDs. Most manufacturers build theirs on ISO 13485:2016, with the additional MDR and IVDR-specific requirements layered in.
Step 3: Conduct Risk Management (ISO 14971)
The risk management file must include a risk management plan, hazard identification, risk estimation, harm evaluation, risk control and verification, a benefit-risk analysis, and a risk management report.
Step 4: Generate Technical Documentation
The CE submission file must cover Annex II of the MDR or IVDR: a device description with specifications and intended purpose, the classification rationale, design and manufacturing information, risk management documentation, a General Safety and Performance Requirements checklist, performance characteristics, software documentation under IEC 62304 where applicable, 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 often the longest lead-time activity for higher-class MDR and IVDR devices. It's required for every MDR device except non-sterile Class I, and every IVDR device except non-sterile Class A.
Identify candidate Notified Bodies.
Check their designation scope under MDR or IVDR, the device codes or technologies they cover, experience with your device type, capacity and waiting times, fees and contract structure, and reputation. Many manufacturers shortlist two to three Notified Bodies, given how limited availability has become.
Submit a pre-application or request for quotation.
This typically includes a device description and intended purpose, risk class and rationale, the expected conformity assessment route, QMS status, company details, and a high-level view of your technical documentation's availability, plus, for IVDR, your performance evaluation approach. The Notified Body confirms whether it can accept the product, provides timelines and pricing, and assigns product codes.
Select your Notified Body.
Base the decision on timelines, price, experience with similar technologies, responsiveness, and, optionally, geographic convenience, then proceed to formal application.
Step 6: Application and Contract Phase
Formal application for CE and ISO 13485 certification.
Submit a formal application, device information including UDI-DI, intended purpose and classification, the conformity assessment route, confirmation of QMS readiness, and a preliminary list of technical documentation. The Notified Body checks the submission for completeness. If ISO 13485 certification isn't yet in place, the QMS manual and mandatory procedures go in alongside an audit application, which can be combined with the MDR or IVDR audit; if certification already exists, the certificate is provided and the additional MDR or IVDR QMS elements are reviewed instead.
Formal proposal and contracting.
The Notified Body issues a service proposal covering work packages, timelines, and assessment plans, plus a contract or certification agreement. You sign the CE marking certification agreement, the ISO 13485 agreement if applicable, confidentiality and financial terms, and the Notified Body's general terms. No documentation review or audit planning starts before the contract is signed.
Step 7: Notified Body Review and Certification Phase
Once the contract is signed, the technical documentation review is scheduled. The Notified Body selects representative devices from your portfolio and runs focused reviews, typically across three rounds, with audits expected near the end to check compliance with MDR, IVDR, and ISO 13485. Once reviews and audits are complete, the Notified Body's certification board issues your CE certificates. This phase typically takes 9 to 24 months, depending on device class and 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 you're located outside the EU, assign UDI-DI and UDI-PI codes, and upload the relevant actor, device, and certificate data into EUDAMED as modules become available.
Step 9: Finalize and Sign the EU Declaration of Conformity
The EU Declaration of Conformity is the legal document in which the manufacturer or authorized representative declares compliance with applicable EU legislation, issued once the conformity assessment and technical documentation are complete. It covers manufacturer information, device identification and risk class, conformity to MDR or IVDR and the GSPRs, applied standards and common specifications, the Notified Body's name and number where applicable, and the conformity assessment procedure used.
Step 10: Affix CE Marking
The CE mark, and the Notified Body number where applicable, must appear on the device, its packaging, and the IFU before the device goes on the market.
Step 11: Post-Market Obligations
Post-market activity is continuous, not a one-time filing. It includes a PMS plan and report for Class I medical devices, PSURs for Class IIa, IIb, and III 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 from limited Notified Body capacity, 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, shortens approval timelines, improves predictability, and reduces regulatory uncertainty.
How Qserve Supports Your CE Marking Strategy
Across every step above, from initial classification through post-market surveillance, our regulatory experts work alongside your team, aligning regulatory strategy with your product development and commercialization goals.
Couldn't find your question?
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.
Do I need my technical documentation fully finished before I approach a Notified Body?
No. In the pre-application stage, you typically only need to provide a high-level overview of what's available, alongside your device description, risk classification, and expected conformity assessment route. Full technical documentation review happens later, once you've signed a contract with your chosen Notified Body.
What's the difference between the technical documentation review and the audit?
They're two separate activities, and the documentation review comes first. Once your contract is signed, the Notified Body selects representative devices from your portfolio and runs the technical documentation review, typically across three rounds of questions and responses. The on-site or remote audit, checking your actual quality management system against MDR, IVDR, and ISO 13485, happens near the end of that process, not alongside it.
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