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

10/06/2026

🏗️ How to structure a CER update process that doesn't derail your team

Step 1: Trigger monitoring (ongoing)
Don't wait for the annual review to ask whether an update is needed. Build a simple monitoring system that flags new literature, safety signals, PMCF results, and regulatory changes as they occur.
Step 2: Scope assessment (as soon as trigger identified)
Before any work begins, assess what the update actually requires. Is this a targeted literature update? Does the benefit-risk analysis need revisiting? Has the state of the art shifted? Scope drives timeline and resource planning.
Step 3: Gap analysis of the existing CER (early)
Review the current CER against the latest Notified Body expectations before updating it. Identify structural gaps that need addressing alongside the new content. This step prevents rework later.
Step 4: Literature update search
Run the update search from the cut-off date of the original, using consistent databases and search terms. Document everything to the same standard as the original search.
Step 5: Data integration
Incorporate new evidence – literature, PMCF results, PMS data, vigilance reports – systematically. Each data source feeds a specific section of the CER.
Step 6: Reassessment of conclusions
Review existing clinical conclusions against the updated evidence base. Do they still hold? Have any conclusions changed? This is where expert judgment is most critical.
Step 7: Benefit-risk update
Update the benefit-risk analysis to reflect new evidence. This section cannot simply be carried forward – it must reflect the current state of knowledge.
Step 8: Review and sign-off
Independent review by a qualified evaluator. Document all changes and decisions clearly.
Step 9: Version control and audit trail
Update the document version history. Ensure all changes are traceable. Archive the previous version.

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

08/06/2026

⚠️ Why CER updates are harder than the original – and what makes them fail

There's a common assumption that a CER update is simply a smaller version of the original.
Less work. Less time. Less complexity.
In practice, the opposite is often true.

Here's why CER updates are frequently harder than the original document – and where they most commonly fail:

📂 The baseline isn't always solid
An update builds on what came before. If the original CER had structural weaknesses – unclear evidence links, incomplete search documentation, a benefit-risk analysis that wasn't well-grounded – the update inherits those problems. Before new work can begin, old gaps need closing.

📊 The evidence landscape has moved
New literature, new PMCF data, new safety signals. An update doesn't just add new information – it requires reassessing whether existing conclusions still hold. That's a more complex task than building conclusions from scratch.

🔄 Consistency is harder than creation
An update must be consistent with the original in methodology, terminology, and structure – while also meeting current Notified Body expectations, which may have shifted. Balancing continuity and currency is a genuine challenge.

🏥 The state of the art may have shifted
If clinical practice in your device's field has evolved, your state of the art section may need more than an update – it may need a full reassessment. That work is rarely factored into update timelines.

📋 Regulatory expectations have increased
Notified Bodies are scrutinising CERs more carefully than they did three years ago. An update written to the standard of the original may no longer be sufficient.

👉 A CER update deserves the same structured approach as the original. Treating it as a lighter version of the same process is one of the most reliable ways to generate a deficiency letter.

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

05/06/2026

💸 The hidden cost of a delayed CER update – what manufacturers rarely calculate

When a CER update is delayed, the most visible consequence is a compliance gap.
But in our project work, we've seen that the real cost goes much further – and most of it never appears on a risk register.

The direct costs:

➡ Accelerated project fees
A CER update that should have taken eight weeks, compressed into three under deadline pressure, costs significantly more – in external fees and internal resource time.
➡ Rework
Rushed updates generate gaps. Gaps generate deficiency letters. Deficiency letters generate another round of work. We regularly see clients spend more time fixing a rushed CER than it would have taken to do it properly the first time.

The indirect costs:
➡ Market access risk
A lapsed or delayed certificate doesn't just affect new sales. In some markets, it can affect the ability to supply existing customers. The commercial consequences can be significant.
➡ Internal resource drain
A CER crisis pulls regulatory, clinical, and quality staff away from other priorities. The opportunity cost is rarely calculated – but it's real.

The calculation most manufacturers don't make:
👉 The cost of a well-structured, timely CER update is almost always lower than the cost of a delayed one.
Prevention is not just good compliance practice.

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

03/06/2026

🔔 When does a CER actually need to be updated? – Triggers you cannot ignore

"We update our CER annually."
This is the answer we hear most often. And while annual updates are a reasonable baseline, they're not the whole picture.
Under the MDR, a CER must reflect the current state of knowledge about your device. That means updates are driven by events – not just by the calendar.

Here are the triggers that require you to revisit your CER – regardless of when the last update was:

📌 New safety issues
Any new adverse event, vigilance report, or field safety corrective action that affects your device. If the safety landscape has changed, your CER needs to reflect that.

📌 Significant design or labelling changes
Any modification that affects the intended purpose, clinical performance, or risk profile of the device triggers a CER review.

📌 Regulatory updates
New guidance documents, updated harmonised standards, or changes to MDR interpretation by Notified Bodies or competent authorities may require updates to how your CER is structured or what it addresses.

📌 Notified Body findings
If your last review generated deficiency letters or observations, these need to be addressed in the next update – not left open.

The practical implication:
👉 Regular updates are a minimum. An effective CER process monitors these triggers continuously – so updates happen when they're needed, not when the deadline forces them.

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

01/06/2026

🩺 Neues Whitepaper: Praxisleitfaden Klinische Bewertung – Regulatorisch sicher. Methodisch belastbar. MDR-konform.

Die klinische Bewertung ist eines der anspruchsvollsten Dokumente in der Technischen Dokumentation gemäß der EU-MDR.
Unser neuer Praxisleitfaden richtet sich an Hersteller von Medizinprodukten, Regulatory- und Clinical-Affairs-Manager, die nicht nur die Anforderungen kennen, sondern sie auch methodisch sicher umsetzen wollen.

Was Sie erwartet:
📋 Regulatorischer Rahmen & strategische Einordnung
📄 Der Clinical Evaluation Plan als Kerndokument
🔍 Evidenzrouten & systematische Literaturrecherche
📊 Bewertung klinischer Evidenz & State of the Art
🔄 Integration von Post-Market-Surveillance-Daten
⚠️ Typische Findings – und wie man sie vermeidet
✅ Best Practices aus der Praxis

Praxisnah. Kostenlos.
👉 https://www.medxteam.de/leistungen/klinische-bewertungen/praxisleitfaden

01/06/2026

⏰ Why your CER update is always late – the real reasons behind the delay

Most manufacturers know their CER needs to be updated regularly.
And yet, in our experience, late CER updates are one of the most common compliance issues we encounter when we start working with a new client.
The reasons are rarely about capability. They're almost always about process.

Here are the patterns we see most often:
🔔 No clear trigger system:
Without a defined system for monitoring update triggers, urgency creeps up unexpectedly.
👥 Unclear ownership:
Clinical evaluation sits at the intersection of regulatory affairs, clinical, quality, and sometimes R&D. When everyone is partially responsible, updates fall through the cracks between teams.
📋 Underestimating the scope:
CER updates are often planned as a quick refresh. In practice, new PMCF data needs integrating, new literature needs screening, the benefit-risk analysis needs revisiting. What was planned as two weeks becomes two months.
📂 Documentation debt from the previous CER:
If the original CER wasn't structured for easy updating – inconsistent formatting, missing search documentation, unclear evidence links – every update starts with a clean-up exercise before the actual work begins.
⏱️ No dedicated resource:
CER updates compete with new product development, audit preparation, and daily regulatory workload. Without protected time and clear prioritisation, they get pushed.
The result is always the same: a rushed update under time pressure, with higher risk of gaps – and a Notified Body review that reflects that.

💡 Need support with clinical investigations, clinical evaluation or post-market activities?
👉 Learn more at https://www.medxteam.de/en/services/clinical-evaluations

27/05/2026

📋 New standard, real deadline – what the DIN EN ISO 10993-1:2026 means for your biological evaluation

A new version of ISO 10993-1 was published in November 2025. The European and German adoption as DIN EN ISO 10993-1 followed in March 2026.

So what has actually changed – and why does it matter?

🔄 Complete restructuring around ISO 14971
The norm has been fully rebuilt around the risk management framework of ISO 14971. Biological safety is no longer assessed in isolation. It must be embedded in a structured risk management process covering hazard identification, exposure assessment, risk estimation, risk evaluation, and risk control.

⏱️ New approach to exposure duration – contact days, not hours
One of the most practically relevant changes: exposure duration is now calculated using contact days – the number of calendar days from first to last use – rather than accumulated hours or minutes.
Intermittent use is systematically addressed: only the actual days of contact are counted, regardless of how long the device is used on each day.

📊 Revised biological effects framework
The term "biological endpoints" has been replaced by "biological effects." The contact categories have been restructured into four groups: intact skin, intact mucous membranes, compromised surfaces or internal tissues, and circulating blood.

🔬 Biological Evaluation Plan (BEP) now formally required
The standard requires a documented Biological Evaluation Plan before any assessment begins. This plan must define scope, contact classification, hazard identification, acceptance criteria, and the strategy for the full evaluation report.

22/05/2026

How to scope your literature search for a CER update vs. a new CER

🆕 New CER – build the complete evidence base
When you're writing a CER for the first time, the literature search needs to be established from scratch.
Your search scope should be broad enough to capture the full landscape of available evidence. Date range typically covers the last 10 years as a minimum – often longer for established device types with a long clinical history and complying with the state of the art.
The objective: a complete, defensible evidence base that supports every clinical conclusion in the CER.

🔁 CER Update – close the gap, don't repeat the work
A CER update has a different objective: identifying new evidence that has emerged since the last search and assessing whether it changes any conclusions.
This means:
✔ Search from the cut-off date of your last search to today
✔ Use the same databases and search terms as the original – consistency is essential for comparability
✔ Focus on what's new – but don't ignore signals that might require revisiting earlier conclusions
✔ Document explicitly that this is an update search and reference the original

⚠️ When an update isn't enough
Sometimes a CER update search isn't sufficient – and a full new search is required. Triggers include:
🔸 Significant change in intended purpose or indication
🔸 New safety signals that require broader evidence review
🔸 Major changes to the device design

The decision between update and full search isn't just administrative. It has direct implications for the quality and defensibility of your CER.

21/05/2026

📚 New blog post just published.

The literature process is one of the most time-intensive parts of clinical evaluation under MDR – and one of the most frequently underestimated.
Not because good literature is hard to find. But because the process around it is often missing the structure it needs.
In our latest article, we break down what a compliant, audit-ready literature process actually looks like – from search strategy to CER conclusions.

What we cover:
➡ Why the CEP has to come before the first database search
➡ How to maintain screening quality when you're facing many results
➡ Where AI can help in screening – and where it can't
➡ How structured extraction improves decision quality
➡ What full-text appraisal needs to cover to hold up to scrutiny
➡ How literature feeds the benefit-risk analysis – and why the connection is often too weak
➡ The three documentation mistakes that consistently trigger findings from Notified Bodies
➡ When a literature update is sufficient – and when it isn't

One thing that stands out from our project work:
👉 The literature is not a section of the CER. It is the foundation of the entire document.

📖 Read the full article here: https://www.medxteam.de/en/medxteam-blog/from-search-to-certification-how-to-make-your-literature-review-process-smarter-in-clinical-evaluation

20/05/2026

⚖️ AI in MDR screening – compliant if done right

Using AI in clinical evaluation is not prohibited under the MDR.
But we regularly speak with teams who are unsure how to implement it in a way that holds up to scrutiny – and that uncertainty is understandable.
The core requirement is unchanged: your screening process must be reproducible, transparent, and fully justifiable.

Three questions we use to test compliance readiness:
1. Can your process be reproduced? Could a different evaluator follow your methodology and reach the same results? If not, the documentation needs work.
2. Is the role of AI explicitly defined? AI as a support tool is defensible. AI as a decision-maker is not. This distinction must be clear in your process description.
3. Is human oversight documented at every stage? Not implied. Documented.

What auditors will look for:
✔ Clear description of the AI tool and its function
✔ Defined scope of AI use across screening stages
✔ Evidence of human review and sign-off at each step
✔ Full traceability of inclusion and exclusion decisions

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