Medical Devices Wiki
Clinical trials with medical devices made easy.
Understand medical and study-specific jargon with the MEDIACC glossary.
NOTE: All information is of a general nature and covers many questions and aspects that we are frequently asked. Of course, it does not replace regulatory or scientific advice. The contents of the website are compiled with the greatest care. Nevertheless, we cannot guarantee that it is up-to-date and complete.
Digital health applications (DiGA)
The Digital Health Care Act (DVG) introduced the "app on prescription". We support manufacturers in developing scientific concepts for proving the positive supply effect and in adding their digital health apps (DiGA) to the BfArM directory. We also provide advice on regulatory requirements according to DiGAV. Benefit from our experience in clinical trials!
Read more >Non-interventional studies
Non-interventional studies investigate drug use under real-life conditions. They include observational studies, efficacy trials and post-approval safety studies.
Read more >Clinical trials
Clinical trials are necessary when existing data do not demonstrate safety and efficacy. They require accurate assessments of innovations and careful planning.
Read more >EU recommendations on decentralized elements in clinical trials - The most important points in brief
The European Union has published its first guidance on digitized trials. These recommendations address digital and decentralized elements in clinical trials. The safety and protection of data is paramount. Each case must be assessed individually and the risks carefully weighed. Particular attention is paid to consent and data management.
Read more >Clinical trials with medical devices
The EU Medical Devices Regulation (EU MDR 2017/745) brings significant changes: no equivalence recognition, more clinical trials, data collection and evaluation, expanded scope and database, higher product qualifications, UDI assignment, new Regulatory Responsible Person (PRRC), changes to Notified Bodies.
Read more >"Other clinical trial" for medical devices
The term "other clinical investigations" refers to various clinical investigations of medical devices. Here, the requirements from Art. 74 and Art. 82 of (EU) 2017/745 (MDR), or in Germany § 3 (4) of the MPDG, must be taken into account
Read more >Investigator-initiated studies (IIT)
Freedom of research is enshrined in the German Basic Law. Investigator-initiated trials (IIT) serve to gain knowledge in order to improve diagnoses and therapies. But commercialization in hospital operations limits space for these non-commercial trials and publications. (138 characters)
Read more >Case studies
Clinical case reports present unique observations from practice and provide new data for the medical literature. We are happy to help you publish your interesting case or case series. Contact us!
Read more >Tests according to AMG
Trials under the AMG assess the safety and efficacy of drugs through clinical trials. They follow a strictly regulated, multi-phase process from laboratory to patient application.
Read more >Decentralized digital clinical trials DDCT
Decentralized digital clinical trials digitize and decentralize processes. They are cost-efficient, patient-centric, diverse and less error-prone.
Read more >Application monitoring (AWB)
Adverse drug reactions (ADRs) collect data on the use of approved drugs and inform clinical follow-up and post-marketing surveillance.
Read more >Dietary supplement studies
Dietary supplement studies test benefits according to GCP. Health claims require scientific evaluation by EFSA and FDA before approval.
Read more >In Vitro Diagnostics
In vitro diagnostic (IVD) devices require a performance evaluation according to EU Regulation 2017/746, which analyzes scientific validity, analytical and clinical performance of the product.
Read more >Clinical trials with cosmetic products
Clinical trials test cosmetic products for safety and efficacy in accordance with GCP guidelines. MEDIACC provides support from conception to implementation.
Read more >Implementation of clinical evaluations of medical devices
Clinical evaluation confirms the safety, performance and benefit of medical devices before they are launched on the market. It is an important part of quality management and risk management.
Read more >Scientific analyses
Scientific analyses help with product development for the healthcare market. They analyze data, evaluate the clinical situation and define medical needs.
Read more >Retrospective analyses
Retrospective analyses examine existing data and are often faster and simpler than prospective studies. They can provide new medical insights or generate hypotheses.
Read more >What is a clinical trial?
A clinical trial is a scientific investigation in which new medical treatments, drugs or therapeutic approaches are tested. People take part voluntarily in order to evaluate the effectiveness and safety of these interventions and thus advance medical research.
Read more >What is a clinical investigation?
A clinical investigation is a detailed examination of a medical device on humans. It is carried out in accordance with strict scientific guidelines and legal requirements in order to assess the safety, tolerability and efficacy of the product. Volunteers (patients and test subjects) play a crucial role in this process.
Read more >What are the differences between a usability test and a clinical investigation?
Usability tests examine the user-friendliness of products. Clinical investigations test the safety and efficacy of medical devices under medical and regulatory supervision.
Read more >What is a medical device?
Medical products are diverse - from simple bandages to high-tech devices. They are used to prevent, detect, treat or alleviate health problems in humans. The EU regulations MDR and the German MPDG set standards for safety and performance. Clinical trials ensure efficacy and safety before and after market launch.
Read more >What different types of clinical investigations of medical devices are there?
The MDR, IVDR and the German MPDG set standards for medical devices and require clinical investigations. There are various forms, e.g. performance, safety and comparative studies, multi-center studies and post-market clinical follow-up (PMCF) after market launch. These ensure the safety and performance of medical devices.
Read more >What is the difference between clinical investigations of medical devices and drug trials?
Commonalities in clinical trials for medical devices and drug trials include ethical principles, approval requirements, patient protection and study phases. Differences relate to product type, trial objectives, regulatory authorities, approval procedures and implementation standards.
Read more >What are DiGA?
DiGA refers to digital health applications, so-called "medical apps on prescription". These are medical devices with a CE mark and a low risk class which, in addition to high requirements for data protection and data security, must also have demonstrated their benefits as a so-called "positive care effect" and their safety in a clinical trial.
Read more >What is an investigational device?
An investigational device is a product that is evaluated for its health and safety aspects as part of clinical trials. Special legal requirements apply to investigational devices
Read more >What is a performance study?
A clinical performance study evaluates the ability of a diagnostic tool to correlate results with a specific health condition. Parameters such as disease detection, accuracy and probabilities are examined.
Read more >What is the difference between provisional and permanent listing of a digital health application (DiGA) in the DiGA directory?
Provisional inclusion of digital health applications (DiGA) in the DiGA directory takes place if safety standards are met, without sufficient proof of a positive healthcare effect; permanent inclusion also requires proof of a positive healthcare effect.
Read more >What is a positive supply effect of a DiGA?
The positive care effect of DiGA can be demonstrated either by the medical benefit or the patient-relevant structural and procedural improvements in clinical studies.
Read more >What are the special features of DiGA clinical investigations?
Clinical studies of DiGA are defined by law, but also have high requirements due to the interpretations of the BfArM, which can be found in the current versions of the DiGA Fast.Track procedure guidelines and in direct contact.
Read more >How should endpoints be selected for a clinical investigations of a DiGA under the fast-track procedure?
Endpoints for demonstrating the positive health care effect of a DiGA in a clinical investigation should be relevant and meaningful for patients, measurable with validated measurement instruments, cover a relevant time period, reflect the standard therapy and target population and also have an unmet medical need or economic benefit.
Read more >Definitions in Digital Decentralized Clinical Trials (DDCT)
Definitions for elements and processes of digital decentralized clinical trials (DDCT) are listed here.
Read more >What are the ALCOA++ principles?
ALCOA++ principles mean that documents must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
Read more >Can ChatGPT or another voice bot make me a clinical protocol for a clinical investigation with a medical device or DiGA?
We asked ChatGPT about this (12/2023) and show his answer here, which is repeated again and again in a similar format:
Read more >May a clinical trial according to EU MDR 2017/745 Article 74 have a confirmatory approach?
A clinical trial according to Article 74 of MDR 2017/745 can also have a confirmatory approach.
Read more >What is the role of a lead investigator in a clinical trial?
The LCP fulfills a legally defined central role to ensure that clinical trials are conducted in accordance with legal requirements and ethical standards and deliver meaningful results.
Read more >What does "sponsor" mean in clinical trials?
The legally defined sponsor of a clinical trial of medical devices ensures the quality and integrity of the clinical trial and the safety of all participants, thereby contributing to the validity of the trial results.
Read more >Do I need a network of clinicians if I want to conduct a clinical trial?
Networks with clinicians have the following advantages: Expert knowledge, patient access, competence in ethical aspects, contacts with authorities and practical experience. Challenges such as time resources, shortage of specialists and conflicts of interest must be taken into account. Nevertheless, the advantages outweigh the disadvantages and improve market entry and presence even after the clinical trial.
Read more >Should patient organizations be involved?
The involvement of patient organizations in clinical trials offers clear advantages, such as risk and cost reduction, patient-relevant research, improved study conduct, early risk identification, easier recruitment, increased trust and acceptance through patient-centered research.
Read more >Definitions for clinical trials with medical devices
Here you will find the most important definitions for your clinical investigation of medical devices or performance evaluations from EU Regulation 2017/745 (MDR), defined in Art. 2 and from the Medical Device Law Implementation Act (MPDG), which regulates medical devices in Germany.
Read more >And what if something doesn't go as planned? Dealing with adverse and serious adverse events in clinical trials
Clinical trials with medical devices require close observation, documentation and reporting of adverse events to ensure safety in accordance with MDR 2017/745 and the MPDG. Reporting obligations and deadlines vary depending on severity and causality and are subject to the guidelines of the MDCG.
Read more >6 simple steps to recognized evidence
With DTC-MED through clinical trials of medical devices and DiGA (DiPA) in 6 steps: from the well thought-out concept to the scientific publication. DTC-MED offers a physical center for virtual digital clinical trials. In 6 steps to recognized evidence: well thought-out conception and planning, compliance with European regulations, focused patient management, highest data quality, legally compliant archiving and scientific evidence generation for approvals, reimbursement by service providers and well-founded conviction of professional and guideline societies.
Read more >Show 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 product.
From the conception to the execution of preclinical and clinical investigations, we support you with customized services.
Find out how MEDIACC can help you achieve reimbursability for your products.