Wie sind die Öffnungszeiten?

Montag 08:00 - 17:00 Dienstag 08:00 - 17:00 Mittwoch 08:00 - 17:00 Donnerstag 08:00 - 17:00 Freitag 08:00 - 17:00

medXteam GmbH

Kontaktinformationen, Karte und Wegbeschreibungen, Kontaktformulare, Öffnungszeiten, Dienstleistungen, Bewertungen, Fotos, Videos und Ankündigungen von medXteam GmbH, Medical and health, Hetzelgalerie 2, Neustadt an der Weinstraße.

Als CRO unterstützt das medXteam Sie während des gesamten Prozesses der Generierung und Bewertung klinischer Daten und bei der Zulassung und Marktbeobachtung von Medizinprodukten

27/02/2026

Checklist Item #1: Is the Intended Purpose Clearly Defined?

Everything in Clinical Evaluation starts here.
The intended purpose is not a regulatory formality — it is the foundation of your entire clinical strategy.
It determines:
✔️ What clinical data you need
✔️ Which patient population is defined for which clinical data is required
✔️ The clinical claims/endpoints you can make
✔️ The application context (user, setting, duration, risk profile)
✔️ The depth of your benefit–risk assessment
If the intended purpose is vague, too broad, or inconsistent across documents, your Clinical Evaluation becomes unstable from the very beginning.

Why this matters
Under the MDR, clinical evidence must be appropriate for the specific intended purpose of the device.
If your claims go beyond what your intended purpose defines — or if IFU, marketing materials, and CER describe different scopes — notified bodies will identify gaps immediately.

Typical mistake
🚩 The intended use is formulated too broadly
or
🚩 Different versions appear in CER, IFU, and marketing documents
Result: Misaligned data requirements, weak clinical justification, and audit findings.

25/02/2026

Checklist: Clinical Evaluation under the MDR – Where to Start

Many manufacturers still treat Clinical Evaluation as a document.
Under the MDR, it is not.
It is a continuous process — from clinical strategy to PMS, PMCF, and regular updates of the Clinical Evaluation Report (CER).

📌 Why this matters:
If you see the CER as a one-time deliverable, you risk gaps in data integration, weak benefit–risk justifications, and audit findings.

Over the next weeks, we’ll walk step by step through the key elements of a robust Clinical Evaluation under the MDR:
✔️ Defining the clinical strategy
✔️ Literature and data requirements
✔️ Equivalence considerations
✔️ Integration of PMS & PMCF
✔️ Structured benefit–risk analysis
✔️ Consistency of claims across documentation

23/02/2026

Pitfall #9: Data Without Objective – Missing a Clinical Evaluation Strategy
❌ The mistake:
Clinical data are collected — but without a clear strategy, route, or objective.
Typical signs:
-Data gathered “just in case”
-No clear decision between own clinical data, equivalence, or Article 61(10) route
➡️ Result: High effort, low regulatory value — and a fragmented CER.
✅ The solution:
Define your clinical evaluation strategy early — in the Clinical Evaluation Plan (CEP).
✔️ Decide upfront on the clinical evaluation route:
-Own clinical data (clinical investigations, literature)
-Equivalence-based approach (technical, biological, clinical)
-Article 61(10) route (justified reliance on clinical performance data)
✔️ Clearly define:
-What questions must be answered?
-Which claims must be supported?
-Which risks require clinical confirmation?

20/02/2026

Pitfall #8: Inconsistent Documents – When Your CER, IFU & Claims Don’t Match
❌ The mistake:
Statements in the IFU, labeling, or marketing materials are not supported by the Clinical Evaluation Report (CER).
Typical red flags:
-Marketing claims stronger than the clinical evidence allows
-Different wording or performance values across documents
-Updates made in one document — but not in others

✅ The solution:
Implement strict traceability and consistency across all user-facing and regulatory documents.
✔️ Define clinical claims centrally in the CER
✔️ Use only CER-backed claims in IFU, labeling, and brochures
✔️ Update documents together
✔️ Keep the complete Technical Documentation consistent

📌 Key principle:
If a statement cannot be traced back to the CER, it does not belong in the IFU or marketing.

18/02/2026

Pitfall #7: No Clear Benefit–Risk Analysis
❌ The mistake:
Benefits and risks are described — but never truly weighed against each other.
What this looks like in practice:
-Separate sections for safety and performance, without integration
-Qualitative statements like “the benefits outweigh the risks”
-No link between residual risks and demonstrated clinical benefit

➡️ Result: The benefit–risk conclusion is not scientifically defensible.
✅ The solution:
Establish a structured, quantitative benefit–risk assessment.
✔️ Use a Benefit–Risk Matrix that links:
-Clinical benefits (measurable outcomes, effectiveness, clinical performance)
-Residual risks (from ISO 14971, PMS, PMCF)
-Severity, probability, and clinical relevance
✔️ Quantify wherever possible

📌 Key principle:
A benefit–risk analysis is not a summary — it is a decision framework.

16/02/2026

Pitfall #6: Ignoring PMS and PMCF Data
❌ The mistake:
Post-Market Surveillance (PMS) and PMCF data remain trapped in separate reports — disconnected from the Clinical Evaluation.
What often goes wrong:
-PMS reports and PSURs are created only to “fulfil a requirement”
-PMCF results are summarized but not clinically interpreted
-No systematic feedback into clinical claims or benefit–risk analysis
-CER updates are done without considering real-world data
➡️ Result: The CER no longer reflects actual clinical use.

✅ The solution:
Use PMS and PMCF as core drivers of the Clinical Evaluation lifecycle.
✔️ Integrate PMS data into the CER
✔️ Use PMCF results to:
-Confirm or refine clinical claims
-Support ongoing benefit–risk justification
✔️ Define clear triggers for CER updates:

📌 Key principle:
PMS and PMCF are not downstream activities — they are continuous evidence generators for the CER.

13/02/2026

Pitfall #5: Literature Without Traceability Is Not Evident
❌ The mistake: The literature review is not reproducible or appears selective.
Typical audit findings:
-No documented search strategy
-Databases and search terms not justified
-Inclusion/exclusion criteria unclear or missing
-It’s impossible to understand why certain publications were selected — and others were not
➡️ Result: The credibility of the entire clinical evaluation is questioned.

✅ The solution:
Treat the literature review as a controlled, transparent process — not a narrative summary.
✔️ Establish a Literature Search Plan
✔️ Maintain a Search Protocol / Log
✔️ Create a Literature Review Report

📌 Key principle:
If someone else cannot reproduce your literature search — it is not compliant evidence.

11/02/2026

Equivalence Is Not a Shortcut — It’s a High Bar

❌ Equivalence is often claimed in the CER, but not fully demonstrated.
Typical red flags:
-Only technical similarities are described
-Biological or clinical equivalence is assumed, not proven
-Access to data of the equivalent device is unclear or missing
-Equivalence is used to avoid generating own clinical data

✅ The solution:
Treat equivalence as a full clinical evaluation route, not a workaround.
✔️ Demonstrate equivalence systematically and completely:
-Technical equivalence → design, specifications, materials, operating principles
-Biological equivalence → materials in contact with the body, duration and nature of contact
-Clinical equivalence → same intended purpose, indications, target population, clinical performance and safety profile
✔️ Ensure sufficient access to data on the equivalent device
✔️ Clearly justify why the equivalent device is relevant as a comparator

🔄 If equivalence cannot be fully demonstrated:
➡️ Switch to another clinical evaluation route

09/02/2026

A Weak State of the Art Undermines Your Entire CER

❌ The State of the Art (SotA) is treated as a purely descriptive chapter — a literature summary without a comparison framework.
Typical red flags:
-No link between SotA and clinical claims
-No measurable benchmarks for comparison with the device

✅ The solution:
Use the SotA as a comparative and analytical tool, not a narrative overview.
✔️ Structure your SotA into Medical SotA & Technical SotA
✔️ Derive measurable parameters:
-Safety benchmarks (e.g. complication rates, adverse event frequencies)
-Clinical Performance benchmarks (e.g. accuracy, success rates, durability)
-Clinical benefit parameters (e.g. outcome improvement, reduced burden)

✔️ Use these parameters as reference points to evaluate:
-Clinical safety
-Clinical performance
-Clinical benefit

👉 Why this matters:
Without a robust SotA, you cannot demonstrate that your device meets or exceeds current clinical practice — and your benefit–risk conclusions lose credibility.

06/02/2026

Pitfall #2: Unclear or Missing Clinical Claims

❌ Clinical safety, clinical performance, and clinical benefit claims/endpoints are often described vaguely — or not at all.
Claims (or endpoints as synonym) remain implicit, qualitative, or scattered across the CER without clear structure.

Typical red flags:
-No distinction between clinical performance and benefit
-Claims such as “safe”, “effective”, or “improves outcomes” without measurable parameters
-No link between claims and clinical data sources

✅ The solution:
Define clinical claims early — already in the Clinical Evaluation Plan (CEP).

✔️ Clearly separate:
➡️ Clinical safety (e.g. incidence and severity of adverse events)
➡️ Clinical performance (e.g. accuracy, success rates, technical outcomes)
➡️ Clinical benefit (e.g. improved diagnosis, reduced complications, patient-relevant outcomes)

✔️ Make every claim:
-Measurable (with predefined endpoints)
-Verifiable

👉 Why this matters:
Without clear, predefined claims, clinical data cannot be interpreted consistently — and benefit–risk conclusions become weak.

04/02/2026

The Most Common CER Mistake: Handling the Clinical Evaluation as ‘Done’
One of the most common and critical mistakes in clinical evaluation under the MDR:
❌ The CER is written once for market access — and then archived.
Under the MDR, this approach is no longer acceptable.
📘 What the MDR Actually Requires
Article 61(11) MDR is very clear:
Clinical evaluation and its related documentation must be updated throughout the entire lifecycle of the device, based on:
-Post-Market Surveillance (PMS) data
-Post-Market Clinical Follow-up (PMCF) data
➡️ A CER that does not evolve with real-world data is by definition non-compliant.
⚠️ Why This Is a Problem
If the CER is not actively maintained:
➡️ New risks remain unassessed
➡️ Changes in State of the Art are missing
➡️ PMS signals are not clinically interpreted
➡️ Benefit–risk conclusions become outdated
These gaps are among the most frequent Notified Body findings.
✅ Best Practice: Think in CER Lifecycles
A compliant CER should be treated as a living document:
✔ Defined review intervals (risk-based)
✔ Clear update triggers from PMS and PMCF
✔ Integration of vigilance, trends, and new literature
For Class III and implantable devices, this typically means at least annual review and update.

💡 Key Takeaway
A CER is not a snapshot.
If real-world data changes, your CER must change with it.

📌 Next pitfall coming soon.

03/02/2026

💡 Did you know? New EU Implementing Decision updates key harmonised standards under the MDR

On 28 January 2026, the European Commission adopted Commission Implementing Decision (EU) 2026/193, bringing an important update to the list of harmonised standards supporting the MDR (EU 2017/745).

❗️With Commission Implementing Decision (EU) 2026/193 (28 January 2026), the European Commission has officially cited EN ISO 14155:2020/A11:2024 as a harmonised standard under the MDR (EU 2017/745).

🔍 Why this is important
EN ISO 14155 is the Good Clinical Practice (GCP) standard for clinical investigations with medical devices.
By being cited in the Official Journal, ISO 14155:2020 together with Amendment A11:2024 now provides presumption of conformity with the relevant MDR requirements.

➡️ https://eur-lex.europa.eu/eli/dec_impl/2026/193/oj

Adresse

Hetzelgalerie 2
Neustadt An Der Weinstraße
67433

Öffnungszeiten

Montag	08:00 - 17:00
Dienstag	08:00 - 17:00
Mittwoch	08:00 - 17:00
Donnerstag	08:00 - 17:00
Freitag	08:00 - 17:00

Telefon

+4963219164000

Webseite

https://www.medxteam.de/

Benachrichtigungen

Lassen Sie sich von uns eine E-Mail senden und seien Sie der erste der Neuigkeiten und Aktionen von medXteam GmbH erfährt. Ihre E-Mail-Adresse wird nicht für andere Zwecke verwendet und Sie können sich jederzeit abmelden.