For market access, continued compliance, and safety.
Clinical Affairs
Clinical Evaluation and Performance Evaluation that withstands Notified Body scrutiny.
Clinical Evaluation and Performance Evaluation are central pillars of the MDR and IVDR. We support manufacturers in building Clinical Evidence in a structured, traceable, and regulatory-compliant manner – from planning through to ongoing updates throughout the product lifecycle.
Clinical Evaluation is not just a formal requirement – it is critical for decision-making.
Clinical Evaluation determines whether your product will be certified, whether your marketing claims hold up, and whether you have a solid foundation for product changes and portfolio decisions. Many manufacturers have clinical data – but lack a structure that will stand up to scrutiny by notified bodies. We bring clarity and traceability to your Clinical Evaluation – without unnecessary complexity.
Our services in the area of Clinical Affairs
Clinical Strategy & Planning
- You start with a clear overall clinical strategy – aligned with your product, risk class, and regulatory context
- Clinical data and gaps are analyzed – before they become a problem
- Clinical activities, Regulatory Strategy, and PMS/PMCF/PMPF are aligned from the outset
Clinical Evaluation according to MDR (CEP & CER)
- Your Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are regulatory compliant, logically structured, and documented to be audit-ready
- Clinical literature is systematically researched and evaluated – with clear conclusions
- Safety, performance, and clinical benefit of your products are quantitatively evaluated based on appropriate parameters
- Inquiries from Notified Bodies regarding Clinical Evaluations are answered in a structured and technically accurate manner
Performance Evaluation according to IVDR (PEP & PER)
- Your Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) meet the specific IVDR requirements
- Scientific Validity, Clinical Performance, and Analytical Performance are documented in a traceable manner
Post-Market Clinical Follow-up (PMCF) and Post-Market Performance Follow-up (PMPF)
- Your PMCF/PMPF activities are meaningful, proportionate, and planned in a regulatory-compliant manner
- PMCF/PMPF results feed systematically into Clinical Evaluation/Performance Evaluation and PMS documentation
- You meet the MDR requirements for PMCF and the IVDR requirements for PMPF – without disproportionate effort
- PMCF and PMPF results are incorporated directly into ongoing clinical and performance evaluation — the cycle is completed in the post-market phase. → Post Market Surveillance
SSCP (MDR)/SSP (IVDR)
- Your Summary of Safety and Clinical Performance (SSCP, MDR) or Summary of Safety and Performance (SSP, IVDR) is complete, consistent, and aligned with Clinical Evaluation/Performance Evaluation and Technical Documentation
- Coordination with Notified Bodies is systematically prepared and supported
- The Summary of Safety and (Clinical) Performance is structured so that product changes and new PMS/PMCF/PMPF data require only minimal updating effort
Integration into the Product Lifecycle
- Clinical Evidence remains current and usable throughout product changes, PMS updates, and portfolio decisions
- Risk management, Post-Market Surveillance, and Clinical Affairs are consistently integrated
Technical Documentation is closely linked to Clinical Evaluation and Performance Evaluation. Learn more about our service area
→ Technical Documentation
Support with queries & audits
- Inquiries from Notified Bodies regarding clinical topics are answered accurately and promptly
- Structured Dialogues with Notified Bodies are prepared and supported in a structured manner
- You go into audits well prepared – clinical nonconformities are clearly addressed
How robust is your clinical evidence?
During an initial consultation, we will clarify the status of your clinical assessment or performance review, identify any gaps and discuss the most appropriate next steps.
Free Initial ConsultationWhen manufacturers come to us
Before MDR/IVDR certification
Clinical strategy must be defined and developed in a way that is compliant with regulatory requirements.
After queries from Notified Bodies
Nonconformities regarding clinical topics must be resolved with technical expertise.
Throughout the product lifecycle
PMCF, PMPF, PMS and product changes require continuous updating.
Our services
What manufacturers say about the collaboration
“What we appreciate about regular services is that it’s not a project that’s delivered. It’s ongoing support — and that makes all the difference.”
Results
from real-world practice
Our clients are best placed to demonstrate what regulatory clarity means in practice.
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about Clinical Evaluation and Performance Evaluation according to MDR/IVDR
Clinical Evaluation is a structured demonstration that a medical device is safe in use, meets its performance requirements, and provides a clinical benefit to the patient. It is based on a systematic collection, analysis, and evaluation of clinical data – from scientific literature, clinical experience, or proprietary Clinical Investigations. The results are documented in the Clinical Evaluation Report (CER), which is mandatory for CE marking and must be kept up to date throughout the entire product lifecycle.
Yes – for all medical devices, regardless of risk class. Even for Class I products, or where demonstration of safety and performance based on clinical data is not appropriate (MDR, Article 61(10)), a documented Clinical Evaluation is still required. However, the scope and depth of the required Clinical Evidence increase with the risk class. We can help you determine the appropriate scope for your product.
Post-market clinical follow-up is the systematic collection of clinical data after placing on the market – to continuously confirm the safety and clinical performance of a product. PMCF is relevant for all product classes, not only high-risk classes. Whether a clinical study is required, literature evaluations and user surveys are sufficient, or a reduced PMCF approach can be justified depends on the device and the existing clinical data.
Both serve to demonstrate safety and performance – but for different product types. Clinical Evaluation according to MDR applies to medical devices, while Performance Evaluation according to IVDR applies to in vitro diagnostic devices. The requirements for documentation, methodology, and evidence differ accordingly. Performance Evaluation demonstrates the diagnostic capability and validity of in vitro diagnostic medical devices, ensuring that these products deliver reliable and valid results. The focus here is on assessing scientific validity, clinical performance, and analytical performance. Clinical Evaluation serves as structured evidence that medical devices are safe in use, meet their performance requirements, and provide a clinical benefit to patients.
We support you in both areas.
Performance Evaluation according to IVDR is based on three pillars of evidence: scientific validity, analytical performance, and clinical performance. Scientific validity demonstrates the association of an analyte to a clinical or physiological condition. Analytical performance demonstrates that the product detects the analyte accurately, precisely, and reliably. Clinical Performance shows that the product fulfills its intended purpose in clinical use. All three pillars are incorporated into the Performance Evaluation Report (PER) – which, together with the Performance Evaluation Plan (PEP), is a mandatory component of the Technical Documentation. We support you with planning, preparation, and ongoing updates.
The MDR requires continuous updates throughout the entire product lifecycle – not only in response to product changes or audits. The specific update frequency depends on the risk class and new clinical findings. Clinical Evaluation updates are based on PMS/PMCF data and are defined accordingly in the PMS/PMCF plan. For updates to the Periodic Safety Update Report (PSUR) and PMCF reports, update cycles are specified by risk class.
The PSUR must be updated annually for Class IIb and III products. For Class IIa products, the PSUR must be updated every two years.
The Post-Market Clinical Follow-up (PMCF) report must be prepared at least annually for Class III products and implants.
Based on the results, we will evaluate whether, and to what extent, the Clinical Evaluation needs to be updated. We ensure that your CER is always up to date.
This occurs more frequently than many manufacturers expect – especially with existing products that were certified under the MDD (Legacy Devices). Notified Bodies increasingly flag insufficient data depth, inadequate equivalence argumentation, or incomplete PMCF data. In such cases, we jointly analyze the gaps and develop a realistic strategy to strengthen the evidence base in a targeted manner – before it becomes a problem for your MDR certification.
Clinical evaluation and performance assessment are decisive for certification – and for any queries raised by the Notified Body. We assess your current status and address any gaps before they become an issue during the procedure.