Introduction
The introduction of Regulation (EU) 2017/745 (MDR) has brought a seismic shift in how medical device manufacturers must approach clinical evidence. MDR places the burden on manufacturers to provide an adequate level of clinical evidence proportionate to the device’s risk profile.
While traditional clinical trials remain the gold standard, the MDR also recognizes alternative data sources—offering manufacturers flexibility if approached correctly.
This document explores how manufacturers can leverage smart, cost-effective clinical data strategies to meet MDR requirements without defaulting to new clinical investigations. It outlines the regulatory framework, practical approaches, and expert insights to help navigate this complex landscape.
The New Regulatory Landscape
The MDR raises the bar by requiring continuous and systematic clinical data collection throughout the product lifecycle. This evidence is central to demonstrating compliance with the General Safety and Performance Requirements (GSPRs).
Key pillars of the clinical evaluation process include:
- A critical assessment of relevant scientific literature,
- Results from clinical investigations,
- An evaluation of alternative treatment options that constitute the State of the Art.
Post-Market Surveillance (PMS) complements this by requiring manufacturers to proactively gather Real-World Evidence (RWE), which is vital for maintaining continuous compliance within an appropriate risk management process.
What Qualifies as Clinical Data?
MDR Article 2(48) defines clinical data as information regarding the safety or performance of a medical device derived from:
- Clinical investigations,
- Scientific literature,
- Published clinical experience,
- PMS activities.
Crucially, real-world data (RWD)—such as surveys, patient registries, and observational studies—also fall within this definition when collected and analyzed rigorously within a methodologically sound procedure.
The Role of MDCG 2020-6 in Legacy Devices
For Legacy Devices—those previously CE-marked under Directive 93/42/EEC (MDD)—MDCG 2020-6 provides specific recommendations. It confirms that while new clinical investigations may not always be required, manufacturers must justify the level of clinical evidence through a critical evaluation of available data. The guidance encourages the use of alternative sources, such as real-world evidence and structured user surveys, as part of a cumulative clinical evidence strategy—provided they are scientifically robust and well-documented.
Understanding “Sufficient Clinical Evidenceâ€
The concept of “Sufficient Clinical Evidence” is pivotal yet flexible. While the MDR does not define it strictly, MDCG 2020-6 clarifies that it hinges on a holistic assessment of data quality and quantity, relative to the device’s risk class, intended use, and design characteristics.
Even manufacturers of Legacy Devices with no historical safety concerns must now provide solid clinical evidence to maintain market approval. In many cases, robust literature reviews, surveys, and RWE can meet regulatory expectations without requiring new trials—if they are methodologically sound and well-documented.
Alignment with ISO/CD 18969
The draft international standard ISO/CD 18969, not yet published, is expected to reinforce the need for a systematic, lifecycle-based approach to clinical evaluation. Although still under development, this standard defines key principles, terminology, and responsibilities related to the evaluation of clinical risks and benefits. It aims to:
- Ensure safety and performance claims are scientifically verified,
- Establish the credibility of clinical conclusions,
- Define the responsibilities of manufacturers and evaluators,
- Promote benefit-risk assessments grounded in human clinical data.
ISO/CD 18969 will apply across the entire lifecycle of a medical device and is intended to assist both manufacturers and Notified Bodies in the assessment of clinical evidence, aiming to become a benchmark for international best practices.
Practical Strategies for Manufacturers
Practical strategies for clinical evidence collection and assessment should be based on four pillars:
- Optimization of Literature Reviews: Comprehensive, up-to-date literature reviews remain a cornerstone of clinical evaluation. Ensure your methodology meets the applicable standards.
- Leveraging Real-World Evidence: Collecting data from registries, surveys, and PMS activities can offer powerful insights—especially for mature devices or those with niche indications.
- Early Definition of Sufficient Clinical Evidence: Proactively define the level of clinical evidence needed in alignment with MDCG 2020-6 and justify it clearly in your documentation.
- Post-Market Data Assessment: Continuously monitor PMS outputs to ensure your clinical evaluation remains dynamic and reflects current use patterns.
Rethink Your Evidence Strategy
Navigating the MDR’s clinical evidence requirements doesn’t always mean launching costly and time-consuming trials. By adopting smart strategies—rooted in scientific rigor and aligned with regulatory guidance—manufacturers can efficiently maintain compliance and competitiveness. Structured methodologies ensure clinical evaluations are credible, traceable, and aligned with both EU regulatory expectations and emerging global standards.
At 1MED, we specialize in helping manufacturers determine whether a trial is truly necessary or if alternative, more agile approaches can achieve the same regulatory outcomes. Our integrated services combine regulatory expertise, clinical strategy, and real-world data solutions tailored to your device’s unique profile.
Looking to optimize your clinical evidence collection and development plans? Contact us today to explore your options with one of our regulatory experts.