We know this part of the road. Precisely.
Getting a medical device into Europe takes many hands. We are the Research Institute and Clinical Research Organisation for medical devices, based in Berlin to guide you with what MDR asks for clinical evidence: from evaluation to reimbursement.
We know the right people for everything around it, digital or on site, across Germany and the EU.
One contact for medical devices in Europe.
- Strategy
- Clinical evaluation
- Clinical investigation (Art. 62)
- CE marking
PMCF studies
Reimbursement
or call us: +49 30 521 044 80
- Real people, no bots.
- Free and without obligation.
- Personal reply.
Which evidence does your device need in Europe?
Clinical evaluation: The structured review of your existing data. We tell you whether it carries under the MDR or where the gap is.
Authorities. Personal contacts to regulators and ethics committees. We ask early, in person, and we know who answers.
Notified bodies. We know who will review your device and what they expect to see.
Study sites. Clinics and practices across Germany and Europe, and our own Digital Trial Centre (DTC-MED®).
Independent Research Institute and CRO for Medical Devices – Experts in Digital Clinical Investigations
We aim to support you in securing reimbursement for your medical devices by leveraging cutting-edge digital technologies and customised clinical trials. We offer full-spectrum assistance from the initial study concept to the utilisation of the results, across Germany and Europe.
Study design
Work with us to design a well thought-out study and project concept based on the needs and requirements of affected individuals and relevant service providers.
Fully digital or hybrid clinical trials
We are experts in implementing digital and hybrid study designs that meet the needs of your projects.
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Clinical investigations of medical devices
We conduct pre- and post-certification clinical investigations to ensure the safety and efficacy of your medical devices.
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Generate evidence for DiGA
We create the best trials for your digital health applications to provide compelling evidence for your products' reimbursability.
Find out more →Unabhängiges Forschungsinstitut und CRO für Medizinprodukte - Experten für digitale klinische Studien
Wir setzen Ihr Ziel um, mit innovativen digitalen Lösungen und maßgeschneiderten klinischen Prüfungen bzw. Studien den Marktzugang (CE-Kennzeichen) oder die Erstattungsfähigkeit Ihrer Medizinprodukte durch Krankenkassen zu erreichen, sei es durch Erlangung des Nachweises des (Zusatz)nutzens, der Wirksamkeit (RCT), des positiven Versorgungseffekts (DiGA) bzw. pflegerischen Nutzens (DiPA), der anwendungsbegleitenden Erfolgsmessung (AbEM), Anwendungsbeobachtungen, PMCF oder retrospektive Ansätze. Nutzen Sie unser digitales Studienzentrum (DTC-MED®) mit nachweislich überlegenen Erfolgswerten für zentrumsbasierte und dezentrale bundes- oder europaweite Rekrutierung und Durchführung.
Unabhängiges Forschungsinstitut und CRO für Medizinprodukte PMCF
Damit Ihre Medizinprodukte über den gesamten Lebenszyklus konform bleiben, übernehmen wir die notwendigen Arbeiten und maßgeschneiderte Studien zur klinischen Nachbeobachtung nach dem Inverkehrbringen (PMCF), sei es durch systematische Erhebung von Anwendererfahrungen, Literaturrecherchen, Auswertung von Registerdaten, prospektive PMCF-Studien oder retrospektive Ansätze – als belastbare Grundlage für die Aktualisierung Ihrer klinischen Bewertung, europaweit.
What our clients say
client rating
MEDIACC has supported more than one in three successful apps on prescription (DiGA) in Germany.
Our expertise extends far beyond conducting clinical trials
From strategy development to operational implementation to publication — we are here to guide you through the jungle of regulations to market-wide acceptance. We draw on more than 35 years’ expertise in science and regulatory affairs to give you focused advice.
Strategy development and consulting
Join us in a strategy workshop to develop the preliminary framework for your clinical trial. We welcome open dialogue: together we mitigate uncertainties and develop individual solutions for your product.
Find out more →Clinical trial concept
Together, we create a customised study and project concept in a kick-off meeting. Your clinical trial is our priority; we will connect you with our trusted network of partners. Exploring digital trial methodologies? Our team offers expert advice on implementing digital solutions.
Find out more →Planning & Preparation
Together, we will transform your clinical trial concept from vision to reality. Our team prepares essential study documents for submission to the competent authority (e.g. BfArM) and ethics committee and supports you in preparing for regulatory consultations. From standard operating procedures to pocket synopses and certificates - we prepare everything you need to succeed. This takes us the most time at the outset: about two to three months.
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Conducting your clinical trial
We will ensure the smooth conduct of your clinical trial, including training of study personnel and monitoring of study progress.
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Publications and Medical Writing
With completed data collection, we move to database closure and in-depth analysis. Our experts will compile a clinical study report and collaborate with you to present your results internationally, ensuring your evidence makes a powerful impact.
Find out more →View the full Catalogue of Services →
We clarify regulatory questions early and in person, with contacts we know by name: committees at EU level, DIN and ISO, the Federal Joint Committee (G-BA) and BfArM. And we point out the hidden costs at the beginning, not at the end.
“Our mission is to improve the lives of patients worldwide, recognising robust clinical trials as an essential pathway to advancing future medicine.”
Managing Partner
PD Dr. med. Caroline Schmidt-Lucke
Behind every trial is a permanent team of more than 25 specialists: medical lead, project management, study physicians and study assistants.
Get to know MEDIACC →Where we are the right choice, and where we are not
We tell you early when a project is better placed elsewhere, and refer you on within our network. That saves you months.
We do it ourselves
Where we are strong
- Preparing clinical evaluations
- Gap analysis of clinical evaluations and identification of the evidence gap
- Clinical trials of medical devices, from strategy to reimbursement
- Digital and decentralised trial conduct
- PMCF
- DiGA and evidence for reimbursement, through to listing in the DiGA directory
- Scientific and market-oriented concepts
- Approval studies
- Personal contact with authorities, notified bodies, study sites and clinics
- European and international partnerships
We refer you
For these, we work with qualified partners
- Phase I to IIb drug trials
- Classification of medical devices
- Manufacture of medical devices
- Development of software as a medical device
- Technical validation
- Advice on medical device law
- Usability testing
- Laboratory work
- Notified body activities
We know the people and put you in touch. In doing so, we also take care to maintain consistently high quality and client satisfaction.
25+
specialists in the permanent team
European and international partnerships
The dots on the map show our partners worldwide. Behind every trial is a permanent team of more than 25 specialists.
Your DiGA in the DiGA directory of the BfArM
Our expertise aids innovators of digital health applications in generating evidence of positive healthcare effects and navigating DiGA directory listing. Our approach is informed by our ongoing dialogue with BfArM, ensuring a clear understanding of their criteria and evidence requirements.
Literature research and evaluation
We conduct comprehensive systematic literature reviews to substantiate sound rationale for the chosen study design and all elements.
Evaluation concept
We support you in the development of an evaluation concept that meets the requirements of the BfArM and details the approach and justification for substantiating the medical benefit.
Systematic data evaluation
Our expertise in systematic data evaluation supports you in reviewing the effectiveness of your DiGA.
Randomised controlled trial
With the appropriate RCT, we support you in proving the positive healthcare effect for listing in the directory and reimbursement by health insurance companies.
Demonstrate the medical benefits of your product
With our many years of experience and expertise, we offer effective solutions to demonstrate the medical benefits of your medical device. From the design to the implementation of registry studies to randomised controlled digital trials, we support you with tailored services.
Find out how MEDIACC can support you in achieving reimbursement of your medical device. Free and without obligation. Write to us: a member of our team will receive your message personally.
Arrange a free initial consultation+49 30 521 044 80You will speak to us directly.