How can a manufacturer sell their medical devices in the European Union (EU)? This is an easy question. You need to show conformity of your device with the EU’s regulatory requirements, which are primarily governed by the Medical Device Regulation 2017/745 (EU MDR).
Sounds easy right!! Unfortunately, this is not an easy process. Clinical evaluation forms the core of your conformity assessment. EU MDR defines ‘clinical evaluation’ as a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
The primary goal of clinical evaluation is to demonstrate performance and safety of the device in accordance with the relevant General Safety and Performance Requirements (GSPRs). To this end various data need to be evaluated. The two main type of data included are:
- Data held by the manufacturer which includes premarket clinical investigations, verification and validation test reports, post-market data etc.
- Data retrieved from literature is used to identify data not held by the manufacturer that are needed for the clinical evaluation.
The data retrieved through literature is used to establish the current knowledge or state-of-the-art as well to collect relevant clinical data. Clinical data is a term that you will frequently come across. So what is clinical data? ‘Clinical data’ means information concerning safety or performance that is generated from the use of the device under evaluation or a device for which equivalence to the device. From the state-of-the-art, we need identify suitable parameters that can be used to evaluate the performance and safety of the device under evaluation, and establish acceptance criteria. These parameters and the acceptance criteria are then used to evaluate the performance of your device.
Risk-benefit analysis is another critical element of clinical evaluation for medical devices, ensuring that the device’s benefits to patients and users outweigh the associated risks. Under the EU MDR risk-benefit analysis is a core requirement for demonstrating compliance with the GSPR. This analysis underpins the device’s approval process and its ongoing market viability.
Clinical evaluation under EU MDR
The MDR emphasizes a lifecycle approach to clinical evaluation, requiring continuous monitoring and updates. Key differences from the previous Medical Device Directive (MDD) include:
- Greater focus on clinical evidence for all devices, including those already on the market.
- Stricter requirements for demonstrating equivalence when using data from similar devices.
- More comprehensive post-market surveillance and PMCF activities.
Challenges in Conducting Clinical Evaluation
- Demonstrating Equivalence: Ensuring the device is technically, clinically and biologically comparable to an equivalent device can be complex. Learn more.
- Data Gaps: Insufficient clinical data may necessitate new clinical investigations, increasing time and cost.
- Regulatory Scrutiny: Notified Bodies have become more stringent, especially for high-risk devices, making detailed and well-supported evaluations critical.
How can RNCS help?
- Plan and execute a thorough literature search
- We leverage various tools to gather and manage data efficiently
- We can help you meet the regulatory requirements as per EU MDR.
Clinical evaluation isn’t just about ticking regulatory boxes—it’s the cornerstone of crafting medical devices that transform patient care while keeping risks at bay. By embracing a forward-thinking and meticulous approach, manufacturers can not only meet compliance standards but also carve out a competitive edge in the fast-paced world of healthcare innovation.
Whether you’re just stepping into the game or fine-tuning your approach, mastering clinical evaluation principles is your golden ticket to thriving in the medical device industry.
For more details, Contact RN Consulting Solutions MedTech Compliance Experts
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