Medical devices wiki

Digital health applications (DiGA)

We support DiGA manufacturers in proving the positive healthcare effect, the BfArM listing and the regulatory requirements of the DiGAV.

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Non-interventional studies

Non-interventional studies for medical devices: Real-life observational studies. MEDIACC customers: Observe national regulations, consult authorities.

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Clinical studies - initial knowledge

Clinical studies are necessary when existing data does not prove safety and effectiveness. They require precise assessments of innovations and careful planning.

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Requirements of the BfArM for DiGA

BfArM places high demands on DiGA for listing in the DiGA Directory: Safety, data protection, interoperability and positive healthcare effect.

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Annex XV of the MDR

MDR Annex XV regulates clinical investigations. Medical device manufacturers: draw up trial plans, observe ethical requirements, comply with existing regulations.

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Essential contents of the FDA guidance for DCT:

FDA publishes guidance for DCTs for more efficient trials and diverse participant groups. MEDIACC clients should consider potential for their study designs.

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Medical Device Coordination Group (MDCG) in the context of clinical studies of medical devices

The MDCG is an important EU expert group for medical device regulation. MEDIACC as CRO follows MDCG guidelines and implements them in order to be MDR/IVDR compliant.

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New guidelines for medical software: What manufacturers and users need to know

MDCG publishes guidelines for medical software. MEDIACC supports the generation of evidence through clinical studies.

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Data management in digital clinical investigations

Digital data management in clinical studies: more efficient, higher quality, but with challenges in terms of security and validation. Regulatory guidelines provide orientation.

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Contents of Annex XIV of the MDR

MDR Annex XIV regulates clinical evaluation and follow-up. The following applies to medical device manufacturers: adapt processes, create CEP and PMCF plan, maintain CER and PMCF report.

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Particular risks in the selection and use of electronic data capture (EDC) systems in fully digital studies

MEDIACC uses its many years of experience to select the optimal EDC solutions for your clinical studies. In doing so, MEDIACC takes into account factors such as performance specifications, data security, user-friendliness, validation, cost-benefit ratio and integration into existing systems. The objective is to efficiently collect high-quality data and optimise study processes.

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Ethical principles of all clinical studies

Clinical studies must comply with GCP and the Declaration of Helsinki. Contact us to ensure that your study design meets these standards.

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Additional risk management for digital decentralised clinical investigations or studies with medical devices

Fully digital clinical studies offer benefits such as improved data integrity and more efficient processes when risks such as data loss, cyber-attacks, validation issues, regulatory challenges and digital barriers are minimised.

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The value of clinical investigations - why evidence levels are as exciting as your favourite TV series

The evidence of clinical studies is categorised hierarchically. Different terms describe similar concepts. High levels of evidence are crucial for authorisation procedures.

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How does MEDIACC fit in with service providers (CRO) for clinical studies?

MEDIACC: Specialist for digital clinical studies of medical devices. Comprehensive support from conception to reimbursement. Contact us for customised, efficient solutions.

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What is a clinical research organisation (CRO)?

Contract research organisations (CROs) support the pharmaceutical industry and medical device manufacturers in planning, conducting, monitoring and evaluating drug trials. CROs often specialise in certain regions, indications or services, with only a few specialising in medical devices.

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Clinical investigations of medical devices - if they are necessary in the context of clinical evaluations

Clinical investigations are often necessary for clinical evaluations to provide evidence of safety and performance. Extensive information is required for the design of a clinical or other clinical investigation to ensure the rights, safety, dignity and well-being of all participants.

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Study design in clinical and other clinical investigations of medical devices

The study design is crucial in clinical research. It includes the research question, study type, study population, observation unit, measurement method and calculation of case numbers. Experienced specialists are required for this.

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Structure of a clinical investigation plan

A comprehensive protocol is complex and requires careful planning from the outset with the involvement of experienced experts. Key elements for creating a clinical investigation plan according to EU regulations and ISO standards include general information, rationale, objectives, design, conduct, data management, risk management, consent/ethics, device handling, reporting and compliance.

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Study types in the study design of clinical investigations of medical devices

The choice of study type is a decisive criterion in the study design of clinical investigations of medical devices. It takes into account scientific criteria, regulatory requirements, available resources and feasibility. The choice of the appropriate study type is crucial in order to generate valid and reliable data that meet the legal requirements and contribute to the scientific evaluation of medical devices.

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What elements does a study concept or study synopsis contain for a clinical investigation of medical devices or digital applications?

The study concept is a central document for clinical investigations of medical devices. It includes objectives, design, participants, treatment plan, data collection, statistics, organisation, risk management, quality assurance, data management and reporting. Careful planning is crucial for the success of the study.

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How is a study design to be seen within a study concept?

The study design is a key element in the study concept for clinical investigations of medical devices. It defines the details for valid data and compliance with regulatory requirements

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What are the elements of a strategy session to generate clinical evidence?

Strategy development for clinical investigations starts with sound planning. MEDIACC supports you with personalised strategy sessions to meet your objectives and regulatory requirements.

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Contents of Article 61 of the MDR

Clinical evaluation for medical devices in accordance with Art. 61 of the MDR. For manufacturers: Plan early, involve experts, dovetail processes, update documentation.

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Risk-based monitoring

Risk-based monitoring is essential for clinical investigations in order to ensure the rights, safety and well-being of participants as well as data quality. A detailed monitoring plan serves as a guide and regulates monitoring, risk control and responsibilities. Qualified monitors oversee compliance with all requirements.

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Optimal evidence generation: Clinical study planning with DTC-MED® in 6 steps

With DTC-MED® in 6 steps through clinical investigations of medical devices and DiGA (DiPA): from the well thought-out concept to the scientific publication. DTC-MED® offers a physical centre for virtual digital clinical investigations. In 6 steps to recognised 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.

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When is it worth carrying out a DDCT?

Digitalisation offers enormous opportunities for clinical investigations, such as increased efficiency, better data quality and cost savings. Factors such as infrastructure, regulation and competences are decisive. We support you in analysing and deciding on the (partial) digitalisation of your clinical study.

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What can go wrong in a clinical investigation? Risk management at the highest level

Clinical studies are complex and require careful planning and risk management. Challenges include regulatory changes, project coordination, financial risks, data management, participant recruitment and ethical requirements.

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Dealing with adverse and serious adverse events in clinical investigations

Clinical investigations with medical devices require close observation, documentation and reporting of adverse events to ensure safety in accordance with the 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.

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What aspects does a clinical investigation need to demonstrate the positive healthcare effect of a DiGA?

To fulfil the complex requirements for DiGA studies and achieve successful inclusion in the BfArM directory, contact MEDIACC for an initial consultation. Our experts will support you in planning and conducting high-quality clinical investigations that meet the strict criteria and optimally position your DiGA.

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Definitions in Digital Decentralised Clinical Trials (DDCT)

Definitions for elements and processes of digital decentralised clinical trials (DDCT) are listed here.

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What does "sponsor" mean in clinical investigations?

The legally defined sponsor of a clinical investigation of medical devices ensures the quality and integrity of the clinical investigation and the safety of all participants, thus contributing to the validity of the study results.

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Should patient organisations be involved in the design of clinical investigations?

The involvement of patient organisations in clinical investigations 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-centred research.

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What are the ALCOA++ principles?

ALCOA++ principles mean that documents must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.

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Do I need a network of clinicians if I want to conduct a clinical investigation?

Networks with clinicians have the following advantages: Expert knowledge, patient access, expertise 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 investigation.

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Can ChatGPT or another LLM make me a clinical investigation plan for a clinical investigation with a medical device or DiGA?

We asked ChatGPT and Perplexity in the PRO version whether they can create a test plan (12/2023 and 6/2024) and show their answers here:

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Can a clinical investigation according to EU MDR 2017/745 Article 74 have a confirmatory approach?

A clinical investigation according to Article 74 of MDR 2017/745 may also have a confirmatory approach.

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What is an investigational medical device?

Investigational medical devices are medical devices in clinical investigations that are evaluated for safety and performance. They are subject to special regulatory requirements.

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What is a positive healthcare effect of a DiGA?

The positive care effect of DiGA can be demonstrated either by the medical benefits or the patient-relevant improvements of structure and processes in clinical studies.

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What is the difference between clinical investigations of medical devices and drug trials?

Similarities in clinical investigations for medical devices and drug trials include ethical principles, authorisation requirements, patient protection and study phases. Differences relate to product type, trial objectives, regulatory authorities, authorisation procedures and implementation standards.

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What are the special features of DiGA clinical investigations?

Klinische Studien von DiGA sind gesetzlich festegelegt, haben jedoch außerdem hohe Anforderungen durch die Auslegungen des BfArM, die den jeweils aktuellen Fassungen des Leitfadens des DiGA-Fast.Track-Verfahrens und in direktem Kontakt zu entnehmen sind.

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What are DiGA?

The term 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 benefit as a so-called "positive healthcare effect" and their safety in a clinical investigation.

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What is the difference between provisional and final 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; final listing requires additional proof of a positive healthcare effect.

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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 evaluate the safety, tolerability and effectiveness of the product. Voluntary participants (patients and test subjects) play a crucial role in this process.

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How should endpoints be selected for a clinical investigation of a DiGA under the fast-track procedure?

Endpoints for demonstrating the positive healthcare effect of a DiGA in a clinical investigation should be relevant and meaningful to 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.

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Retrospective analyses

Retrospective analyses examine existing data and are often faster and simpler than prospective studies. They can provide new medical findings or generate hypotheses.

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What is a medical device?

Medical devices are diverse - from simple bandages to high-tech appliances. They are used to prevent, recognise, treat or alleviate health problems in humans. The EU MDR regulations and the German MPDG set standards for safety and performance. Clinical investigations ensure effectiveness and safety before and after market launch.

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What different forms of clinical investigations of medical devices are there?

Clinical investigations of medical devices include conformity assessment, PMCF studies, other clinical investigations and performance studies for in-vitro diagnostics.

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What is a clinical study?

A clinical study 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.

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What are the differences between a usability test and a clinical investigation?

Usability tests analyse the user-friendliness of products. Clinical investigations test the safety and effectiveness of medical devices under medical and regulatory supervision.

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Scientific analyses

Scientific analyses are systematic investigations to gain new insights and test theories in all disciplines.

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Performance evaluation of in-vitro diagnostics (IVD)

In vitro diagnostics (IVDs) require a performance evaluation in accordance with EU Regulation 2017/746, which analyses the scientific validity, analytical and clinical performance of the product.

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Clinical studies with cosmetic products

Clinical studies with cosmetic products ensure their safety, effectiveness and tolerability and are essential for product development.

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From planning to authorisation: clinical evaluation of medical devices ‍

Before launching a medical device on the market, manufacturers must demonstrate its clinical performance, safety and clinical benefit by means of a clinical evaluation. This evaluation is based on data from specialised literature or clinical studies and is part of the technical documentation for CE marking.

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What is a performance study?

Clinical performance studies examine the ability of a device to deliver clinically relevant results and evaluate various diagnostic parameters in accordance with the IVDR.

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Tests according to AMG

AMG trials assess the quality, effectiveness and safety of medicinal products through clinical investigations. They follow a strictly regulated, multi-phase process from laboratory to patient application.

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Case studies

Clinical case reports present unique medical findings. Case studies and case series describe observations from practice.

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Observational study

Observational studies collect data on the use of authorised medicinal products and provide information on clinical follow-up and post-marketing surveillance.

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Food supplement studies

Food supplement studies test benefits according to GCP. Health claims require scientific evaluation by EFSA and FDA prior to authorisation

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Decentralised digital clinical studies (DDCT)

Decentralised digital clinical studies digitise and decentralise processes. They are cost-efficient, patient-centred, diverse and less error-prone.

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"Other clinical investigation" for medical devices

"Other clinical investigations" refers to various clinical investigations of medical devices. The requirements from Art. 74 and Art. 82 of (EU) 2017/745 (MDR), or in Germany §3 (4) and §47 of the MPDG, must be taken into account here

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EU Recommendations on Decentralised Elements in Clinical Trials - The most important points in brief

The European Union has published its first guideline on digitalised trials. These recommendations concern digital and decentralised elements in clinical studies. The security and protection of data is the top priority. Each case must be assessed individually and the risks carefully weighed up. Particular attention must be paid to consent and data management.

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Human studies

Human studies test the safety and effectiveness of treatments in humans.

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Clinical studies (trials) with medical devices

The EU Medical Device Regulation (EU MDR 2017/745) brings significant changes: no recognition of equivalence, more clinical investigations, data collection and evaluation, expanded areas of application and database, higher product qualifications, UDI assignment, new person responsible for regulation (PRRC), changes to notified bodies.

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Annual conferences of professional associations - why should you keep an eye on them?

Annual conferences promote the exchange of knowledge and innovation. Manufacturers present new products to raise awareness and forge partnerships.

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Investigator-initiated studies (IIT)

Investigator-initiated studies serve to gain knowledge. MEDIACC supports doctors in planning, conducting and publishing this research.

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Cross-sectional studies

Cross-sectional studies collect data at one point in time to analyse the prevalence of characteristics or diseases without showing causal relationships.

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Clinical investigations of medical devices with CE mark, regulatory categorisation

Clinical investigations of CE medical devices in intended purpose without invasive or stressful procedures: Ethics committee necessary, authority not necessarily. Regulations depending on initiator. Only for risk classes I and IIa.

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Therapeutic trials

Therapeutic trials test new treatments for effectiveness and safety in order to improve existing therapies. They are strictly regulated and ethically investigated.

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When is consultation by an ethics committee sufficient?

Ethics committees consult research projects on ethical standards. Authorities must be involved in the testing of medicinal products and medical devices.

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What is randomisation in clinical studies and why is it used?

Randomisation in studies randomly assigns participants to groups to ensure objective treatment results without systematic differences.

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Sustainability of DDCT

Digital studies increase efficiency and reduce CO2. MEDIACC study shows 90% CO2 savings. Use DDCTs for more sustainable clinical research.

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Participant recruitment and retention: an insight into a key variable

Participant recruitment and retention are crucial for clinical studies. They include the identification, inclusion and retention of suitable subjects.

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Basic requirements for medical devices

Basic requirements of the MDR ensure the safety and performance of medical devices and are essential for CE marking.

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Authorisation studies

Regulatory studies evaluate the safety and performance of medical devices to enable their marketing authorisation in Europe.

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Wie ist mit interkurrententen Ereignissen in klinischen Studien umzugehen?

The estimand concept precisely defines the treatment effect in studies to ensure transparent and comprehensible results for physicians and authorities.

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Advantages of digital clinical studies: evidence-based decision support

In an analysis of comparative clinical studies, we compared key performance indicators (KPIs) of clinical studies in hybrid and fully digital decentralised (possibly also "virtual") clinical studies.

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Improving the quality and reliability of clinical investigations / MDCG recommendations

MDCG 2024-3 provides guidance on the preparation of clinical investigation plans for medical devices based on MDR and ISO 14155:2020 to prevent regulatory issues.

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Xenotransplantation

Xenotransplantation uses animal organs for humans. In Europe, studies are regulated by the EMA and national authorities such as the PEI.

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Under what circumstances can an EDC system be used as a source of health data in a clinical investigation of medical devices?

An EDC system can be used as a source of data in clinical investigations if it is validated and fulfils safety and regulatory requirements.

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Differences between medical technology and medical devices

Medical technology and medical devices are central components in the healthcare system are intended for use in humans to diagnose or treat diseases and are subject to strict legal requirements to ensure safety and effectiveness.

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What are hybrid clinical studies?

Hybrid clinical studies combine on-site and digital methods, improving efficiency, accessibility and data quality in clinical research.

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What does application-related performance measurement mean?

The application-accompanying performance measurement evaluates digital health applications on usage, satisfaction and health data with the objective of quality assurance and pricing.

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Indicators for the quality of clinical studies

Quality and key indicators for clinical studies: Highest data quality, efficient recruitment, strict compliance. Digital solutions for better results.

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Medical and regulatory writing: an overview

Medical and regulatory writing are crucial for scientific publications and the approval of medical devices by health authorities.

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Quality assurance systems in clinical investigations

MEDIACC's quality assurance system ensures efficient, compliant clinical investigations with the highest standards of patient safety and data integrity.

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Good clinical practice - what is it?

GCP principles ensure the ethical and scientific quality of clinical studies. Focus on participant protection and data integrity

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Scientific publications for rapid and deep market entry of innovative medical devices

A targeted publication strategy is crucial for the market success of innovative medical devices in order to gain trust and scientific acceptance.

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Yeti in research

The Yeti of research stands for mysterious studies. Distinguish between myths and real results to make informed decisions.

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Draft of the Medical Research Act of 29 May 2024

Bundestag consults on medical research law to strengthen the research centre. Simplifications for clinical investigations and amendments to existing laws are planned.

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General requirements and principles of clinical investigations / recommendations of the MDCG

MDCG 2023-1 bietet Leitlinien zur Ausnahme von Gesundheitseinrichtungen gemäß MDR für individuell angefertigte Medizinprodukte.

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Allgemeine Anforderungen an klinische Prüfungen zur Konformitätsbewertung von Medizinprodukten

Klinische Prüfungen zur Konformitätsbewertung von Medizinprodukten: Ziele, Anforderungen und wichtige Aspekte gemäß EU-Verordnung 2017/745 (MDR).

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Allgemeine Anforderungen an klinische Prüfungen zur Konformitätsbewertung von Medizinprodukten gemäß EU-Verordnung 2017/745 (Medical device regulation, MDR)

MDR-konforme klinische Prüfungen: Essenziell für Medizinprodukte-Konformität. Fokus auf Sicherheit, Leistung und Ethik. Detaillierte Anforderungen erläutert.

Procedure for clinical investigations of medical devices that already bear the CE marking

The MDR regulates clinical investigations of CE-marked medical devices involving invasive or burdensome procedures. Special requirements for sponsors and authorities apply.

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How are "other clinical investigations" defined in the EU Regulation 2017/745 (Medical device regulation, MDR) and what requirements apply to them?

MDR defines "other clinical investigations" as non-conformity related studies. Ethical and scientific standards apply despite reduced requirements.

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How do research organisations ensure that personal information about individuals remains confidential?

Anonymisation removes personal identifiers, pseudonymisation replaces identifying characteristics. IDAT are identifying data, MDAT are medical data of patients.

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