CE Marking Consultancy for In Vitro Diagnostic Devices – Regulation (EU) 2017/746 (IVDR)
At EUmAccess GmbH, 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
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
Submit for audit & approval
- 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
Who Needs CE Marking Under IVDR?
- IVD Manufacturers (EU & Non-EU)
- Non-EU Manufacturers (Must appoint an EU Authorized Representative)
- Distributors & Importers (Must verify device compliance)
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
Drop here a note
contact@eumaccess.com
Call us Directly
+49 621-76-44-10-101
EUmAccess GmbH
At EUmAccess GmbH, we specialize in providing expert regulatory and compliance solutions to businesses with a focus on the Medical Devices (MD) and In Vitro Diagnostic (IVD) sectors, we assist manufacturers in navigating the complex regulatory landscape, ensuring smooth market entry and compliance with EU directives and regulations.