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Kontaktinformationen, Karte und Wegbeschreibungen, Kontaktformulare, Öffnungszeiten, Dienstleistungen, Bewertungen, Fotos, Videos und Ankündigungen von medXteam GmbH, Medizin und Gesundheit, 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

12/08/2026

Clinical data, clinical evaluation, clinical evidence – three terms that sound similar but mean different things. Article 2(51) defines the one that ties it all together: clinical evidence.

👉 Swipe for the breakdown.

10/08/2026

You've chosen your strategy – now, where does the actual clinical data come from?
Many manufacturers underestimate how many sources they already have at hand – and overlook the ones a Notified Body expects to see. Here's how to map them systematically.

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05/08/2026

Performance, clinical performance … and finally the following results from clinical performance: clinical benefit. Under MDR, it's not enough for a device to work – it has to benefit the patient. And that has to be defined too.

👉 Swipe for the breakdown.

03/08/2026

💡 Did you know?

Only the manufacturer can assign a UDI – never the distributor. The MDCG has just clarified a practice that's more widespread than you might think.
In its new Position Paper MDCG 2026-5 (July 2026), the MDCG addresses a recurring issue: distributors obtaining UDI-DI codes in their own name from EU issuing entities. Here's what you need to know 👇
The scenario
A distributor markets a device under its own brand name (permitted under Art. 16(1)(a) MDR), while keeping the manufacturer's details on the label. The problem? Some distributors then request their own UDI-DI codes directly from an issuing entity – linked to them, not the manufacturer.
The clarification ✅
Assigning two different UDI-DIs for the same device sold under two brand names is fine – but the assignment must be made solely by the manufacturer.
Per Annex VI, Part C:
🔹 2.2 – The manufacturer shall assign and maintain unique UDIs for its devices.
🔹 2.3 – Only the manufacturer may place the UDI on the device or its packaging.
So the manufacturer registers both groups of UDI-DIs in EUDAMED – the ones for its own brand and the ones for the distributor's brand – all linked to the manufacturer.

29/07/2026

💡 Did you know?

The EU expanded the list of "well-established technologies" under the MDR – and for some implantable and class III devices, that means real regulatory relief.
On 29 June 2026, two Commission Delegated Regulations were published in the Official Journal, both amending Regulation (EU) 2017/745:
📄 (EU) 2026/1451 – expands the list of implantable and class III devices exempted from the obligation to perform clinical investigations (Article 61(6)(b)).
📄 (EU) 2026/1359 – expands the list of class IIb implantable devices exempted from the per-device technical documentation assessment (Article 52(4)).

⚠️ One important clarification
Exemption from clinical investigations does not mean exemption from clinical evaluation. Manufacturers of the listed devices still have to plan, conduct and document a full clinical evaluation under Article 61.

27/07/2026

Performance. Clinical performance. These two terms get used interchangeably all the time – but they're distinct levels that build on each other.
Mixing them up is one of the most common reasons clinical evidence doesn't hold together. Here's how they connect.
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22/07/2026

If "performance" is the ability to fulfil the intended purpose – what makes it clinical? This is where medical impact and patient benefit come in.

👉 Swipe for the breakdown.

20/07/2026

"Performance" sounds self-explanatory – but under the MDR it has a very precise meaning. And it's the foundation for everything that follows.

👉 Swipe for the breakdown.

16/07/2026

Everyone talks about "clinical data" – but MDR is very specific about what actually counts.

Article 2(48) names exactly four sources.

👉 Swipe for the breakdown.

13/07/2026

💡Before you collect a single data point – decide on your strategy.
One of the most expensive mistakes in Clinical Evaluation? Choosing the wrong route to clinical evidence – and only realising it months in.
Equivalence? Own clinical data? Existing literature? The right strategy depends on your device, your data, and your classification.
👉 Swipe through for a practical way to decide.

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

Website

https://www.medxteam.de/

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