In the world of medical devices, clinical evidence is the bedrock of safety, effectiveness, and market readiness. But why is clinical data so vital and what exactly does clinical development require?
Clinical data forms the foundation for every phase of a medical device’s lifecycle, from the initial concept through post-market surveillance.
Clinical data and their sources are defined as follows:
„Clinical data“ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
– clinical investigation(s) of the device concerned,
– clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
– reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
– clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;Regulation (EU) 2017/745 (MDR) Article 2, paragraph 48
This data, gathered from literature, preclinical testing, and dedicated clinical investigations, drives the conformity assessment essential for market authorisation. According to the MDR, manufacturers must create and follow a Clinical Development Plan. This plan contains your strategy how you intend to systematically collect data both before and after the device enters the market. This plan is a core requirement of the Clinical Evaluation Plan mandated in Annex XIV of the MDR.
With the MDR, standards for clinical data and studies have intensified. This affects not only new devices but also established products transitioning to meet MDR criteria. This emphasis ensures that only devices meeting high safety and efficacy standards reach patients. Yet, these more rigorous standards bring challenges especially start-ups and SMEs, and manufacturers of innovative products.
So, what types of clinical studies exist, and how do you determine which is most suitable for your medical device?
In this blog, we’ll look at the diversity of clinical study types, showing how they serve as a cornerstone for ensuring safe and effective medical devices.
„Finding the Right Fit“- Which Type of Clinical Studies Best Supports Your Medical Device?
To determine the best type of clinical study for your medical device, it’s essential to consider two key factors: the stage of clinical development and the specific purpose of data collection.
1. The Stage of Clinical Development
The stage of clinical development aligns with the product development phases, from initial concept through validation, comprehensive safety & performance testing, and subsequent post-market surveillance
2. Purpose of Clinical Data Collection
Defining the purpose of the clinical data beforehand is crucial. Do you need data for research to support the state of the art, particularly if the product is novel? Do you need the data to calculate an appropriate effect size for a robust performance demonstration, or to substantiate the product’s clinical performance, effectiveness, safety, and clinical benefit for conformity assessment? Or do you need additional data on a marketed device to address specific performance, clinical benefit, or safety questions?
Table 1 provides an overview various types of clinical studies and investigations in accordance with the stage of development and the purpose of data collection.
This broad selection of study types allows manufacturers to gather meaningful evidence on safety, performance, and benefits through tailored, often more cost-effective study designs beyond traditional pivotal trials. This enables the generation of additional clinical data that supports not only conformity assessment but also product development, treatment methodologies, reimbursement strategies, and strategic decision-making.
Conclusion: Different Types of Clinical Studies Unlock Multiple Paths to Strengthen Medical Device Evidence
Well-planned clinical development secures market authorisation, supports long-term success and ensures patient safety.
Clinical studies and investigations are critical for demonstrating a medical device’s safety, performance, and benefits—a requirement that the MDR has reinforced with higher standards. Particularly for high-risk products and innovations, clinical investigations are often essential when existing data is insufficient.
But “clinical investigation” encompasses a range of study approaches beyond traditional, often costly, pivotal trials, offering effective ways to gather valuable clinical evidence on safety, performance, and benefits with reduced effort and cost.
You want to dive deeper into the topic? Then stay tuned for the upcoming articles!
Meanwhile you can find guidance in the following documents:
MDCG 2020-5 Guidance on clinical evaluation – Equivalence (April 2020)
https://health.ec.europa.eu/document/download/575a0f79-e3a0-4a96-9ce0-930576c12aa2_en?filename=md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf
MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence (December 2023)
https://health.ec.europa.eu/document/download/1b5f9cc0-cea0-4459-921f-eaf4b4f80983_en?filename=mdcg_2023-7_en.pdf
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices (April 2020)
https://health.ec.europa.eu/document/download/a6d29444-b5d5-4afb-8024-10be85256aa7_en?filename=md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en.pdf
MDCG 2021-6 – rev. Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation (December 2023)
https://health.ec.europa.eu/document/download/f124f630-389e-4c45-90dc-24ec0a707838_en?filename=mdcg_2021-6_en.pdf
References:
- European Committee for Standardization. ISO 14155:2020Clinical investigation of medical devices for human subjects — Good clinical practice. Brussels: CEN-CENELEC Management Centre, 2020 ↩︎
Need assistance with planning and executing your clinical study or investigation?
Our team guides you through all steps of your clinical study—from selecting the optimal study design to compliant implementation. This way, you can save time and costs without compromising on quality. Use clinical studies as a strategic tool to advance your product development effectively and establish a strong foundation for a successful market launch.
We are here to help and support you in developing an optimal clinical strategy for safe, effective, and market-ready products. Our expert team ensures smooth planning and execution of clinical studies that meet both, regulatory requirements and your project goals.
Explore our website to learn more about how we can support you as a medical device manufacturer. Feel free to contact us at studien@vascage.at.
