Europe-CE Marking MDR / IVDR

CER, PMS, PMCF, PSUR, SSCP

Key Regulatory Documentation for MDR 2017/745 & IVDR 2017/746

At Alpine Quality Consultants, 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

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

  • 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)

  • Key Requirements (MDR Article 86, IVDR Article 81)
  • 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 AQC?

Contract Manufacturers & Suppliers

Regulatory Experts

Ensuring seamless MDR & IVDR compliance

EU Authorized Representatives

End-to-End Documentation Support

From CER to SSCP

Distributors & Importers

Notified Body

Competent Authority Compliance

Medical Device & IVD Manufacturers

Efficient & Reliable Process

Minimize delays & regulatory risks

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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