What capabilities should a CRO for medical device clinical studies possess?

A Contract Research Organization (CRO) for medical devices supports manufacturers as an outsourced research partner in the planning, execution, and evaluation of clinical investigations and PMCF activities. Because a CRO specializing in medical devices is more familiar with the specific MDR, ISO 14155, and practical requirements of MD studies, it reduces regulatory risks and avoids costly detours stemming from a 'pharma mindset'.

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A CRO with medical device DNA understands the specific characteristics of these types of studies to generate clinical evidence efficiently and in compliance with regulations.

This can be illustrated by the following points:

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1. Regulatory and Standards Expertise

• Proficient handling of the EU MDR (Regulation (EU) 2017/745) and its national implementations, e.g., the MPDG in Germany, especially the requirements for clinical investigations and "other clinical studies" or PMCF. This applies equally to the respective local regulations in other major regions such as the USA, China, and others.
• In-depth knowledge of ISO 14155 for clinical investigations of medical devices (Good Clinical Practice) and ideally other relevant standards, such as ISO 13485 for quality and medical device quality management systems, and other standards relevant to the specific medical device.
• Understanding the intended benefits/claims and intended purpose of a medical device and requirements for closing evidence gaps in the clinical evaluation.
• Familiarity with current MDCG guidelines on clinical investigations, study protocols, and investigator brochures, such as MDCG 2024‑3 and MDCG 2024‑5, which specify requirements for clinical investigation plans and design.
• Ensuring the use of clinical data throughout every development cycle of an innovative, data-driven medical device, compliance with regulations, and leveraging transformative opportunities.
• Knowledge and experience in the use of digital medical devices and those with Artificial Intelligence (AI) and their associated regulations.
• Knowledge of the requirements of ethics committees, regulatory approvals (e.g., BfArM/PEI in Germany), as well as European or other internationally relevant procedures for the coordinated assessment of multinational studies.

2. Study Design and Planning

• Ability to develop an appropriate study design (retrospective, pre- or post-market, interventional or observational, PMCF) based on the clinical evaluation and risk class.
• Support in formulating study objectives, hypotheses, primary and secondary endpoints, selection of appropriate measurement instruments, inclusion and exclusion criteria, and statistical assumptions.
• Creation or co-creation of key documents such as study protocols, investigator brochures, patient information, and informed consent forms in accordance with MDR, MPDG, ISO 14155, and the relevant MDCG guidelines.
• continuous risk management.
• Experience with digital patient-centric studies.
• Established, robust, and fair contract structures

• Practical feasibility analyses, site screening, and recruitment planning, potentially utilizing digital and analog tools for efficient patient engagement.

3. Operational Execution and Monitoring

• Established quality management system with clearly defined processes for site initiation or own decentralized study center with innovative technologies (incl. AI support), monitoring, safety reports, protocol deviations, and CAPA management.
• Experienced monitors/CRAs who are familiar with the requirements of ISO 14155, MDR, and national regulations and support study sites in implementing regulatory and ethical requirements in daily practice.
• Expertise in handling national procedures, e.g., monitoring of the study by state authorities after approval.
• Ability to support even complex, multinational studies in coordinated EU assessment procedures (or in other regions), including harmonization of requirements of various member states.
• Trained and experienced in-house study personnel and regulatory affairs specialists or competent selection of suitable sites for hybrid studies.

4. Data Management, Biostatistics, and Analysis

• Professional clinical data management with validated systems (e.g., eCRF, EDC), defined data flow architecture, query management, and ensuring data integrity and protection.
• Biostatistical expertise for sample size calculation, randomization, definition of analysis populations, and execution of statistical analysis according to protocol and regulatory expectations.
• Creation of tables, listings, and figures, as well as statistical reports that can directly feed into clinical study reports and technical documentation according to MDR.
• Ability to place study results in the context of clinical evaluation and the benefit-risk profile and to prepare them comprehensibly for Notified Bodies and authorities.
• Retrospective data analyses and work with and on registries.

5. Quality and Compliance Structure

• Certified or at least formally established QM system that demonstrably covers regulatory requirements for clinical investigations (MDR, ISO 14155, GCP, ISO27001).
• Traceable SOP landscape for all study-specific processes (monitoring, safety management, data management, audit, training), including regular training and documentation of employee qualifications.
• Internal and external audits, risk management processes, and quality controls that ensure studies are auditable at all times and compliant with regulatory expectations.

6. Medical, Regulatory, Biostatistical, and Therapeutic Expertise

• Interdisciplinary teams with expertise in medicine, biostatistics, data management, project management, and regulatory affairs to competently support manufacturers throughout all study phases.
• Experience with various medical device classes and technologies, as well as specific indications, to appropriately adapt study designs to product characteristics and clinical practice.
• Availability of consultation on specific issues such as PMCF strategies, post-market studies, Real-World Evidence, or registry solutions.

7. Transparent collaboration with the sponsor and all other stakeholders

• Clear distribution of roles and responsibilities between sponsor and CRO, e.g., through contracts and delegation logs, as the sponsor retains regulatory responsibility.
• Transparent cost structures, e.g., traceable unit or line items, as well as disclosure of passed-through third-party costs, to avoid later budget surprises.
• Regular communication regarding project status, milestones, and risks within a structured project management framework.

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Important: It's not just about knowing the individual points, but about the seamless and efficient combination of all aspects — to legally ensure the dignity of our patients and to obtain robust and reliable results that are recognized by all involved parties.

Interested? Contact us for an initial consultation!

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