ANSWERED ON THIS PAGE:
- What is the regulatory process for IVDs in Europe under the IVDR, and how does it differ from the former regulation, the IVDD?
- What is the European classification scheme for IVDs under the IVDR?
- How can Emergo by UL support IVD manufacturers with IVDR compliance?
What is the regulatory process for IVDs in Europe under the IVDR, and how does it differ from the IVDD?
CE marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE marking indicates that an IVD device complies with the European In Vitro Diagnostic Regulation (IVDR 2017/746) and that the device may be legally commercialized in the EU. The IVDR went into effect in May 2022, replacing the previous In Vitro Diagnostic Medical Devices Directive (IVDD) and brought significant changes to the European regulatory landscape for IVD manufacturers.
Key differences between the IVDR and IVDD:
Stricter classification system
Most IVDs now require Notified Body involvement, whereas under IVDD, approximately 80% were self-certified.
Expanded technical documentation
Requirements are more detailed and aligned with general safety and performance requirements (GSPRs).
Clinical evidence expectations
Manufacturers must now submit a Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) demonstrating scientific validity, analytical performance and clinical performance.
Post-market requirements
Obligations for post-market surveillance (PMS) and post-market Performance follow-up (PMPF) are expanded and formalized.
Risk management
Fully integrated with technical documentation and aligned with ISO 14971.
UDI and EUDAMED registration
Mandatory unique device identification (UDI) system and device registration in the European Database for Medical Devices (EUDAMED).
The regulatory process now typically includes:
- Device classification assessment
- Gap analysis and technical documentation preparation
- Performance evaluation and clinical evidence development
- Notified Body conformity assessment (where required)
- EU Authorized Representative appointment (for non-EU companies)
- Post-market surveillance planning and documentation
The IVDR creates a more rigorous, multistep process that requires strategic planning, robust evidence generation and clear regulatory strategy, making experienced consulting critical to success.
CE marking IVD classification system under IVDR
The IVDR uses a new, risk-based classification system outlined in Annex VIII, replacing the IVDD’s list-based approach. This change means more IVDs now fall into categories requiring Notified Body oversight.
The IVDR classification scheme includes:
Class A (lowest risk)
Laboratory instruments, specimen receptacles (sterile/nonsterile). Class A nonsterile devices can still be self-certified.
Class B
Moderate risk devices, such as some immunoassays or fertility tests.
Class C
Higher risk devices, including many infectious disease tests and companion diagnostics.
Class D (highest risk)
Devices detecting life-threatening diseases, blood screening, or determining blood compatibility.
CE IVD approval process: Step-by-step guide
Europe’s In Vitro Diagnostic Devices Regulation 2017/746 has been effective since May 26, 2022. See our IVDR Resource Center for IVD Manufacturers for detailed insights. The CE process for IVDs is similar to that for medical devices, but there are some key differences. Download our chart explaining the CE marking process for IVDs. Please note that significant changes to this process may occur once Europe enforces the new IVDR.
The Regulation EU 2024/1860 provides a staggered extension of the transition period outlined in the IVDR under certain conditions. Please see our on-demand webinar, Regulation EU 2024/1860 and IVDR compliance in Europe, for more information.
CE certification services for IVD manufacturers
IVD manufacturers who want to become better prepared for certification compliance success may be interested in our assistance in a range of areas, including:
- Notified Body selection and engagement
- Conformity assessment options based on classification
- Technical documentation review services
- Quality management system (QMS) certification support
- Post-certification maintenance requirements
IVDR technical documentation file preparation services
IVD manufacturers must compile a technical documentation file showing compliance with the IVDR. Your IVD technical documentation file must include information about your design, intended use, risk assessment and route to compliance with the IVDR requirements. For some classes of IVDs, a Notified Body must review the technical documentation to issue a CE marking certificate. Once completed, it must be made available to European Competent Authorities upon request.
We help medical device and IVD companies prepare Technical Files and Design Dossiers to obtain CE Marking. Learn more about our Technical File services.
Emergo by UL provides comprehensive, step-by-step support to help IVD manufacturers navigate IVDR compliance efficiently and confidently.
As part of our European IVD registration services, Emergo by UL experts can assist with the following:
- Identify the proper classification for your IVD, if unclear
- Prepare gap assessments of existing technical documentation
- Compile readiness reviews identifying compliance gaps and actions required before engaging a Notified Body
- Review regulatory strategy development for CE marking and market access planning
- Develop and review performance evaluation plans (PEP) and performance evaluation reports (PER)
- Compile risk management file (RMF) and update in accordance with ISO 14971
- Prepare technical files or updates compliant with IVDR Annex II and III
- Create or review of post-market surveillance (PMS) and post-market performance follow-up (PMPF) documentation
- Assist with Notified Body selection and applications
- Act as your official Authorized Representative in Europe
- Help you comply with ISO 13485:2016 and prepare for certification audits as needed
Emergo by UL represents hundreds of IVD companies worldwide, including:
Small and medium-sized enterprises (SMEs) seeking scalable, full-service regulatory support
Established manufacturers requiring technical documentation reviews, gap assessments or market expansion strategy
Startups and early-stage companies ready to invest in premium regulatory consulting.
Manufacturers of:
- Software-based IVDs (including AI-driven diagnostics)
- Companion diagnostics (CDx)
- High-risk diagnostics and complex devices
- Legacy devices transitioning from IVDD to IVDR
We have helped register thousands of IVDs in Europe and many other markets, such as Canada and Australia.
Why choose Emergo by UL?
Manufacturers trust Emergo by UL because we offer:
Deep IVDR expertise
Our experts stay current with evolving guidance and Notified Body expectations.
Customized step-by-step regulatory support
Customized services to meet your compliance and business goals.
Global reach
Experience supporting customers in all major IVD markets.
Common questions regarding EU CE marking for in vitro diagnostic (IVD) medical devices
- Do we need an Authorized Representative (EC REP) if we are marketing a self-certified IVD?
Yes. You must select an EC REP if you do not have a place of business in Europe, regardless of the category or classification of your IVD. Read more about Emergo Authorized Representation services.
- Are Notified Body audits required for all types of IVDs?
Unless you are marketing a self-certified IVD device, you will need the intervention of a Notified Body and a Notified Body CE certificate. In fact, most IVD manufacturers will need to engage Notified Bodies as part of the conformity assessment procedures under the In Vitro Diagnostic Regulation (IVDR 2017/746).
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- European In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process
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- UK Regulators Update Guidance on IVD Registrations with Expiring CE Certificates
- Regulation (EU) 2024/1860 and IVDR Compliance in Europe
- IVDR Resource Center for IVD Manufacturers
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