IVDR | Regulation (EU) 2017/746 - Medical Devices & IVDs Technical Consultancy

CE Marking Consultancy for In Vitro Diagnostic Devices – Regulation (EU) 2017/746 (IVDR)

At Alpine Quality Consultants, we provide expert CE Marking consultancy services to help In Vitro Diagnostic (IVD) manufacturers comply with Regulation (EU) 2017/746 (IVDR) and achieve seamless market access in the European Union (EU).

What is CE Marking for IVDs Under IVDR (EU 2017/746)?

CE Marking under IVDR (EU 2017/746) is a mandatory certification that confirms an IVD device meets EU safety, performance, and regulatory requirements. It is essential for selling IVDs in the European Economic Area (EEA) and ensures product quality, reliability, and regulatory conformity.

Required for all In Vitro Diagnostic Devices (Class A, B, C, D)
Ensures compliance with IVDR 2017/746
Confirms safety, accuracy, and performance of IVD devices
Mandatory for market access in the EU

Understanding the EU IVDR 2017/746 Conformity Assessment Routes

Under EU IVDR 746, conformity assessment pathways depend on the classification of IVDs (Class A, B, C, D). Our consultants guide you through the appropriate assessment route for a smooth certification process.

Self-Certification (Class A Non-Sterile IVDs)

Manufacturers can self-certify compliance by preparing a Technical File and Declaration of Conformity (DoC).
No involvement of a Notified Body is required for non-sterile Class A IVDs.

Notified Body Conformity Assessment (Class A Sterile, B, C, D IVDs)

Class A Sterile devices require Notified Body involvement only for sterility assessment.
Class B, C, and D IVDs must undergo full conformity assessment with Notified Body intervention.

Full Quality Assurance (Annex IX – Class B, C, D IVDs)

The manufacturer’s Quality Management System (QMS) undergoes a comprehensive audit by a Notified Body.
A CE Mark is granted upon successful compliance verification.

Type Examination (Annex X – Class C & D IVDs)

Notified Body assesses the design and performance of the IVD.
Required for high-risk IVDs before CE certification approval.

Batch Verification (Annex XI – High-Risk Class D IVDs)

Class D IVDs require additional batch verification by a Notified Body before market release.
Critical for infectious disease diagnostics and high-risk assays.

Key Changes in IVDR Compared to IVDD

Stricter Classification Rules – New risk-based A-D classification system
More Involvement of Notified Bodies – Most IVDs now require Notified Body certification
Stronger Clinical Evidence Requirements – More emphasis on clinical performance & risk assessment
Enhanced Post-Market Surveillance (PMS) – Stronger obligations for manufacturers & economic operators
Mandatory EUDAMED Registration – All devices and manufacturers must be registered in EUDAMED

Our CE Marking Consultancy Services for IVDR Compliance

IVD Device Classification & Regulatory Strategy

Identifying the correct IVDR risk classification (Class A, B, C, D)
Determining the appropriate conformity assessment route

Technical Documentation & Performance Evaluation

Preparing IVDR-compliant Technical Files & Performance Evaluation Reports (PER)
Ensuring compliance with Annex II & III of IVDR 2017/746

EU Authorized Representative (E.A.R.) Services

Acting as your official EU Representative for regulatory compliance
Managing EUDAMED registration & post-market surveillance (PMS)

Notified Body Selection & Certification Support

Assisting in selecting a Notified Body (for Class B, C, D devices)
Supporting the audit, conformity assessment & certification process

Risk Management & Post-Market Surveillance (PMS)

Implementing ISO 14971:2019 risk management requirements
Developing Post-Market Surveillance (PMS) & Vigilance plans

CE Marking Training & Compliance Consulting

Providing expert training & workshops on IVDR requirements

CE Marking Process Under IVDR 2017/746

IVD Device Classification – Determine risk class (A, B, C, D)
Conformity Assessment – Choose the appropriate certification pathway
Performance Evaluation & Technical Documentation – Prepare required documents & testing reports
Notified Body Certification (If Required) – Submit for audit & approval
EUDAMED Registration – Register the manufacturer, device, and UDI in EUDAMED
Declaration of Conformity (DoC) & CE Marking – Issue the DoC and affix the CE Mark
Post-Market Surveillance (PMS) & Vigilance – Ensure ongoing compliance & reporting

Key Documentation for EU IVDR 746 Compliance

Technical Documentation & Design Dossier – Comprehensive documentation of device specifications and analytical performance.
Performance Evaluation Report (PER) – Evidence-based assessment of scientific validity, analytical performance, and clinical performance.
Risk Management File – Documented risk assessment in compliance with ISO 14971.
Post-Market Surveillance (PMS) Plan & Reports – Compliance with ongoing monitoring and vigilance requirements.
Declaration of Conformity (DoC) – Manufacturer’s legal statement confirming IVDR compliance.
UDI (Unique Device Identification) – Ensuring full traceability of IVD devices.
Quality Management System (ISO 13485 Certification) – Aligning QMS with IVDR and regulatory requirements.

Who Needs CE Marking Under IVDR?

IVD Manufacturers (EU & Non-EU)

MS Certification Services

Regulatory Services

Market Access

Representative Services

Trainings

Expert Services

Accreditation Services