Key Regulatory Documentation for MDR 2017/745 & IVDR 2017/746
At EUmAccess GmbH, we assist medical device and in vitro diagnostic (IVD) manufacturers in preparing and maintaining critical regulatory documents, ensuring compliance with EU MDR 2017/745 and IVDR 2017/746.
Below is an overview of the essential documents required for CE Marking, post-market surveillance, and regulatory compliance:
Clinical Evaluation Report (CER) – MDR 2017/745
- What is a CER?
- A Clinical Evaluation Report (CER) demonstrates that a medical device meets safety and performance requirements based on clinical data. It is required for all devices under MDR 2017/745 and is continuously updated throughout the device lifecycle.
- Key Requirements (MDR Annex XIV, Part A & MEDDEV 2.7/1 Rev. 4)
- Systematic literature review & clinical investigation data
- Equivalence assessment with similar devices (if applicable)
- Post-market clinical follow-up (PMCF) integration
- Risk-benefit analysis & clinical validation
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How We Help
- CER writing & gap analysis
- Clinical data collection & evaluation
- Notified Body review support
Post-Market Surveillance (PMS) – MDR & IVDR
- What is PMS?
- Post-Market Surveillance (PMS) is an ongoing process that monitors device safety, performance, and compliance after market launch.
- Key Requirements (MDR Chapter VII, IVDR Chapter VII)
- Establishing a PMS Plan (MDR Annex III)
- Collecting & analyzing real-world data
- Updating risk management & clinical evaluation documents
- Reporting adverse events & trends
- How We Help
- PMS Plan development & implementation
- Data collection & reporting
- Compliance with EUDAMED & Competent Authorities
Post-Market Clinical Follow-Up (PMCF) – MDR 2017/745
- What is PMCF?
- Post-Market Clinical Follow-Up (PMCF) is part of PMS and ensures ongoing clinical safety & performance assessment.
- Key Requirements (MDR Annex XIV, Part B)
- Continuous collection of clinical data
- Addressing residual risks & long-term safety concerns
- Justifying non-performance of PMCF (if applicable)
- How We Help
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- PMCF Plan & Report development
- Clinical study design & execution
- Integration with CER & risk management
Periodic Safety Update Report (PSUR) – MDR & IVDR
- What is PSUR?
- The Periodic Safety Update Report (PSUR) provides an annual safety & performance review for Class IIa, IIb, and III medical devices.
- Key Requirements (MDR Article 86, IVDR Article 81)
- Aggregated safety data analysis
- Risk-benefit assessment updates
- Integration with PMS & PMCF findings
- How We Help
- PSUR preparation & submission
- Compliance monitoring & Notified Body coordination
- Risk management updates
Summary of Safety and Clinical Performance (SSCP) – MDR 2017/745
- What is SSCP?
- The Summary of Safety and Clinical Performance (SSCP) provides transparent clinical information to healthcare professionals & patients for Class III and implantable medical devices.
- Key Requirements (MDR Article 32)
- Device description & intended use
- Summary of clinical data & PMCF findings
- Residual risks & safety measures
- Published in EUDAMED & accessible to the public
- How We Help
- SSCP preparation & compliance review
- EUDAMED submission support
- Translation & readability assessment
Why Choose EUmAccess GmbH?
- Regulatory Experts – Ensuring seamless MDR & IVDR compliance
- End-to-End Documentation Support – From CER to SSCP
- Notified Body & Competent Authority Compliance
- Efficient & Reliable Process – Minimize delays & regulatory risks
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.