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Clinical and Medical Affairs

Clinical evaluation.

Implement clinical evaluations in accordance with the MDR and MEDDEV guidelines using a methodologically sound approach. We prepare comprehensive Clinical Evaluation Reports (CERs)—including systematic literature reviews and rigorous evidence assessment—for your technical documentation.

Clinical Evidence Review Team conducts a systematic literature review

What is a clinical evaluation? According to Article 61 of the MDR and MEDDEV 2.7/1 Rev. 4, a clinical evaluation is the systematic demonstration that a medical device is safe and provides clinical benefit. It is based on clinical data from the literature, equivalent products, or the manufacturer’s own studies, and must be updated throughout the product’s entire lifecycle.

What requirements does the MDR impose on clinical evaluation?

The MDR (Medical Device Regulation) has fundamentally tightened the requirements for clinical evaluation compared to the old MDD:

  • MDR Annex XIV now requires a systematic clinical evaluation, fully and methodically documented, for all risk classes without exception.
  • Proving equivalence has become significantly more difficult under the MDR: The direct equivalence requirements (clinical, biological, technical) are extremely strict.
  • The SSCP (Summary of Safety and Clinical Performance) is mandatory for all implantable and Class III devices and is made publicly available.
  • The CER must be updated regularly and proactively—not only prior to initial approval, but also on an ongoing basis as part of post-market surveillance (PMS).
Is your current Clinical Evaluation Report already 100% compliant with the latest MDR requirements and MEDDEV 2.7/1 Rev. 4?
The medical writer completes the clinical evaluation report

Our clinical evaluation services.

We produce comprehensive, methodologically robust clinical evaluations that meet the standards of any Notified Body.

Clinical Evaluation Plan (CEP)
Development of the Clinical Evaluation Plan as the fundamental basis for systematic evaluation. We define the scope, the equivalence strategy, the precise search strategy, strict inclusion and exclusion criteria, as well as the acceptance criteria for safety and performance.
Systematic literature review
Comprehensive, tamper-proof database searches (PubMed, EMBASE, Cochrane) conducted strictly in accordance with the CEP search strategy. We ensure that the selection of relevant publications is methodologically sound and properly documented, including an assessment of the level of evidence.
Clinical Evaluation Report (CER)
Complete CER preparation in accordance with MEDDEV 2.7/1 Rev. 4. Includes a detailed product description, a robust equivalence argument (where applicable), a synthesis of clinical evidence, a critical residual risk assessment, and the final conclusion regarding product safety.
SSCP & CER Update
Professional preparation of the Summary of Safety and Clinical Performance (SSCP) for your implants and Class III devices. We also handle regular CER updates based on new PMS and PMCF data.

How does ENTOURAGE conduct its clinical evaluation?

Structured in 5 phases — from scoping to the PMCF plan.

01

Scoping

Define the clinical question, assess equivalence, and establish a data strategy.

02

Literature review

Systematic literature search according to MEDDEV 2.7/1. Evaluation and appraisal of all sources.

03

CER Issuance

Preparing a Clinical Evaluation Report: Risk-Benefit Analysis, State of the Art, Clinical Evidence.

04

PMCF Plan

Develop a post-market clinical follow-up plan. Design a PMCF study as needed.

05

Lifecycle Update

Annual CER updates, PSUR integration, and responses to new clinical data.

CA
“A clinical evaluation is not a one-time document—it is a living record. Notified bodies review not only the content, but also whether the manufacturer has understood the process.”
Clinical Affairs Team, ENTOURAGE

Frequently Asked Questions About Clinical Evaluation Under the MDR.

What exactly is a Clinical Evaluation Report (CER)?
A CER is the documented, final outcome of the clinical evaluation conducted in accordance with MDR Annex XIV. It contains a detailed description of the medical device, the strategy chosen for gathering clinical evidence, the results of the systematic literature review and data analysis, and the binding conclusion regarding clinical safety and performance. It is a central component of the technical documentation.
When is literature data alone sufficient for clinical evaluation?
Literature data alone is sufficient only if there is sufficient and, above all, relevant clinical evidence from the literature for the specific product in question (direct data) or for a product that has been demonstrated to be absolutely equivalent (equivalence argument). Under the MDR, the requirements for demonstrating this equivalence are significantly stricter. For new products without direct predicate devices, proprietary clinical PMCF data is often required.
How often does a clinical assessment need to be updated?
The MDR does not specify a strictly fixed deadline, but instead requires a risk-based frequency. For high-risk devices (Class III and implantable), the CER must be updated at least annually based on new PMCF data and PMS plan results. For Class IIa/IIb devices, this is typically done every 2 to 3 years, or immediately upon the emergence of significant new clinical findings.
What exactly is the difference between CER and SSCP?
The CER (Clinical Evaluation Report) is an internal, highly detailed technical assessment conducted by the manufacturer. The SSCP (Summary of Safety and Clinical Performance), on the other hand, is a shorter document derived from the CER and intended for healthcare professionals and patients. The SSCP is published centrally in the European EUDAMED database and is subject to rigorous review by the Notified Body prior to publication.
How often does the clinical evaluation need to be updated?
At least once a year for Class III devices and implants. For Class IIa/IIb devices, at least every 2–5 years. Additionally, when new clinical data becomes available, in the event of a field safety correction action (FSCA), or when changes are made to the product.
Can we do without clinical trials?
Yes, provided there is sufficient clinical data from the literature and evidence of equivalence. However, the MDR imposes stricter requirements for demonstrating equivalence than the old MDD. For Class III implants, clinical studies are generally required.

Additional expertise in clinical medtech documentation.

Expertise

State-of-the-Art Assessments

The state of the art as an essential element of the CER.

 Expertise

Post-Market Surveillance

Valuable PMS data for continuous CER updates.

 Expertise

PMCF Services

Proactive collection of clinical evidence to supplement data.

Evidence that convinces Notified Bodies.

Let our experts prepare your clinical evaluations. Methodologically sound, 100% MDR-compliant, and ready for any audit.

Submit a project inquiry.

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