CRO for medical devices: from clinical evaluation and clinical investigations to PMCF
We facilitate reimbursement eligibility for your medical devices. We conduct your clinical trial ourselves or with qualified partners, digitally, across Germany and Europe, physician-led.
or call us: +49 30 521 044 80
- Real people, no bots.
- Free and without obligation.
- Personal reply.
For manufacturers of medical devices, digital health applications (DiGA) and in vitro diagnostics
Across disciplines, covering all indications and risk classes I to III, with a focus on class IIa and above.
- Implantable and long-term invasive medical devices
- Active therapeutic devices, including those with an integrated diagnostic function such as closed-loop systems or AEDs
- Active devices for diagnosis and monitoring
- Software and AI as a medical device
- DiGA, with evidence of the positive healthcare effect for DiGA listing
- In vitro diagnostics under the In Vitro Diagnostic Medical Devices Regulation (IVDR)
Data analysis for the clinical evaluation, clinical investigation (Art. 62) for CE marking, trial for reimbursement or DiGA, PMCF after market entry
The four most common reasons why manufacturers come to us. In the initial consultation, we tell you which of them applies to you, and whether you need a trial of your own at all.
Clinical evaluation
The structured review of your existing clinical data, which you use to demonstrate the benefit and safety of your device. We tell you honestly whether your existing data are sufficient or where a gap remains.
Approval study: clinical investigation of medical devices (Art. 62)
Literature or equivalence data are no longer sufficient. You need clinical data of your own for CE marking or an extension of indication. We first establish what scope the investigation actually requires, and then conduct it.
Reimbursement eligibility through service providers
Evidence for NUB and G-BA procedures, the German Medical Technical Aids Register, added benefit, positive healthcare effect for DiGA listing. This is precisely where many manufacturers get stuck.
PMCF
Not optional, but mandatory: to systematically demonstrate safety and performance with clinical data even after CE marking. So that the certificate remains valid. We plan the PMCF study, conduct it digitally and deliver the PMCF evaluation report the notified body expects.
Why manufacturers of medical devices work with MEDIACC
Trial conduct under one roof
Concept development, submission, trial conduct and analysis are coordinated by one dedicated contact: physician-led, with our own study team.
A coordinated network
Where specialists are needed, we bring them on board. The partners keep their tasks, and we coordinate the handovers. For you, it remains one contact, not five.
Digital, across Germany and Europe
Our Digital Trial Centre (DTC-MED®) replaces many scattered study sites. How decentralised trials are regulated →
Exclusively medical devices
No parallel pharmaceutical division drawing away capacity and focus. Experience from over 650 clinical studies.
Direct lines to authorities and committees
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.
Human expertise plus technology
We use AI where it adds value and keep the regulatory framework around it under control: data protection, the AI Act and medical device law work hand in hand so that, in the end, the patient is safe.
What clients and partners say about MEDIACC
“On a substantive level, I have nothing to complain about and always felt very well taken care of at Mediacc. [...] The longer we worked together, the more successful the collaboration became.”
“The collaboration with Mediacc was consistently characterised by high professionalism, methodical diligence, and remarkable flexibility. [...] What stands out is the team's ability to proactively guide complex regulatory processes — especially in the context of coordination with the BfArM — [...].”
Repeatedly evaluated and funded by the German Federal Ministry of Research for over 20 years.
The clinical trial process: from first enquiry to clinical study report
Five steps, plainly named. Expand any step for more detail.
1Free initial consultation
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Free initial consultation
A no-obligation discussion to understand your project: which device, which research question, how much time pressure. You receive an initial assessment of whether you need a trial at all and, if so, which type.
So that we know how we can support you. Tried and tested several hundred times.
Arrange a free initial consultation →2Strategy workshop
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Strategy workshop
This is where we go into depth: classification, evidence requirements, regulatory framework, risks. We say early on what will be difficult and what it will cost, instead of surprising you with it later.
For the success of your trial from the very start.
3Concept development and planning
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Concept development and planning
In the kick-off meeting, we decide together whether the trial will be conventional, hybrid or fully digital as a decentralised trial (DDCT-MED®). We work through a few rounds with you until the concept is settled, and then plan in detail how the trial will be conducted.
So that your concept is robust before it is submitted.
4Submission and trial conduct
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Submission and trial conduct
Submission to the competent authority and the ethics committee, then trial conduct with monitoring. You do not need to master regulatory affairs to get your trial up and running.
So that you can focus on your product.
5Analysis and clinical study report
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Analysis and clinical study report
Database closure, data analysis, report writing. On request, we support you through to scientific publication.
In any case, we stand behind your study report.
What does a clinical trial cost? We point out the hidden costs before they arise
We can only quote a reliable price once we know your project.
Professionals know this, and we do not pretend otherwise. What you can expect from us is something else: that we know where the hidden costs lie, that we can name them, and that we point them out at the start instead of springing them on you later.
What makes a trial more expensive:
- Recruitment takes longer than planned
- More study sites than necessary
- Protocol amendments during the trial
- Requests for additional information from the competent authority or the ethics committee
- A longer trial duration
How we keep costs down:
- We plan recruitment realistically, with experience from over 650 clinical studies
- Fewer sites thanks to digital or hybrid trial conduct
- A carefully designed protocol from the outset, so that amendments remain rare
- A responsibility matrix defines who takes on what
We have already conducted such trials. What we say at the start therefore has substance.
Set up to be audit-ready
Regulations
All processes in accordance with ISO 14155 and ICH-GCP, in line with the MDR, IVDR and MPDG and the German regulations BÄO and BMV-Ä.
Data protection and information security
Our own in-house data protection officer. Our company and processes are audited against GCP. ISO 27001: recertified three times in a row without nonconformities, recertification process under way.
Trial operations
Site initiation visit with training of study personnel, ongoing monitoring with progress and vigilance reports, verification of complete documentation after the last participant, close-out visit.
Responsibilities
A responsibility matrix defines which processes we, our partners or you take on. This keeps budgeting flexible.
Associations and standardisation
Member of the BVMA. We work with partners who meet the BVMA’s quality standards. Contributed to drafting ISO 14155.
Available when it matters
Reports of serious adverse events and serious incidents reach you within the statutory time limit.
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.
What prospective clients really ask
How long does a clinical investigation under Article 62 of the MDR take in practice?
The statutory timelines of the ethics committee and the federal higher authority account for the smaller part. In practice, based on over 300 approval studies across all risk classes, a clinical investigation usually takes two to five years from preparation to database closure, plus around six months for analysis and reporting. Recruitment, site contracts and the number of study sites account for the largest share. Detailed timelines in Wiki_MEDIACC →
Is a clinical investigation of a CE-marked device less expensive?
Sometimes. If the investigation remains within the certified intended purpose and no additional invasive or burdensome measures are added, the MDR treats it as a post-market clinical follow-up (PMCF) investigation, with a lighter regulatory burden. Outside the intended purpose, the full requirements of Articles 62 to 81 apply. What matters are the study objective, intended purpose, risk profile and patient access. We first clarify whether the protocol stays within the intended purpose, and then calculate a study-specific cost model.
What does a DDCT-MED® trial cost compared with a conventional one?
Fewer sites, fewer on-site visits, shorter duration, higher retention rates – the cost advantages of a DDCT-MED® trial come mainly from time savings, not from compromises on data quality.
Let us talk about your trial
An initial, no-obligation discussion, free of charge. 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.
Still unsure which trial you need? See strategy development and consulting