Johanna Fugelstad and Anna Sahlholm, Clinical Development, GBA Key2Compliance
It is not uncommon that manufacturers think of the required structured literature search as yet another checkbox and that it is performed very late in the process of finalizing the technical documentation. Or it is performed once and never updated. Thinking ahead, the literature search can provide highly valuable insights, streamlining the road to market.
The introduction of the EU Medical Device Regulation (MDR) has placed stricter demands on manufacturers when it comes to clinical evidence, risk management, and post-market surveillance. Meeting these requirements can be challenging, especially for companies transitioning from the more lenient Medical Device Directive (MDD).
One of the most effective ways to navigate these challenges is through a structured literature search. A well-planned and methodically conducted literature review can provide manufacturers with:
- A strong foundation of clinical evidence to support regulatory submissions
- A clearer understanding of potential risks and safety concerns
- Key insights to guide the design of clinical studies when additional data is required
- Less tedious questions from Notify Bodies during technical file review
In this post, we’ll break down why a structured literature search is an essential tool for manufacturers working toward MDR compliance.
A Strategic Tool for MDR Compliance
Under MDR, manufacturers must demonstrate that their medical device is safe, effective, and backed by sufficient clinical evidence. This requirement applies not only to new devices but also to legacy products that were originally approved under MDD.
With a structured literature search the manufacturer can:
- Identifying existing clinical data – Reviewing published studies, systematic reviews, and meta-analyses to find relevant evidence supporting the device’s safety and performance, especially useful for devices where article 61.10 (clinical data is deemed not appropriate), is applied or for manufacturers of medical device software which rely on algorithms based on knowledge published in the scientific literature.
- Benchmarking against similar devices – Understanding how a product compares to competitors or predicate devices already on the market. This data can also be used to develop good performance and safety objectives for the clinical evaluation and be used as input for the clinical development plan and study design.
- Avoiding unnecessary clinical investigations – If high-quality evidence is already available, manufacturers may be able to reduce or refine the scope of additional clinical investigations.
By systematically gathering and analyzing scientific literature, manufacturers can build a well-supported Clinical Evaluation Report (CER)—a crucial component of MDR compliance where comparison to State-of-the-Art has been emphasized.
Identifying and Addressing Potential Risks
Risk management is a key pillar of MDR, requiring manufacturers to continuously assess and mitigate risks throughout a device’s lifecycle. A structured literature search plays a critical role in this process by:
- Detecting risks – Reviewing case studies, post-market surveillance reports, and adverse event databases to identify safety concerns.
- Spotting emerging safety issues – Keeping up with the latest research to uncover new risks that may not have been previously documented.
- Enhancing post-market surveillance – Ensuring that risk assessments remain up to date with the most current data.
By integrating literature search findings into risk management processes, manufacturers can anticipate potential regulatory challenges and take proactive steps to address them.
Input to Design of Clinical Studies
If existing literature does not provide enough evidence to support MDR requirements, a manufacturer may need to conduct a clinical investigation. A structured literature search is invaluable in this phase, as it helps to:
- Define relevant study endpoints – Understanding what clinical outcomes have been used and accepted in previous studies.
- Optimize study design – Learning from past trials to determine the best methodologies, patient populations, and study durations.
- Justify study requirements – Providing a solid scientific rationale for sample sizes, inclusion/exclusion criteria, and follow-up strategies.
A well-informed study design increases the chances of a smooth regulatory approval process while minimizing unnecessary costs and delays.
Literature Search as a Strategic Asset for MDR Compliance
For medical device manufacturers, a structured literature search is much more than a compliance exercise—it’s a strategic tool that strengthens clinical evidence, improves risk management, and informs smarter study designs. By adopting a structured, data-driven approach to literature review, manufacturers can better support MDR compliance efforts, enhance patient safety, and streamline MDR submissions.
At GBA Key2compliance Clinical Development, we specialize in conducting comprehensive literature searches that align with MDR requirements. We also offer trainings, enabling manufacturers to acquire the competence in-house.
If your team needs expert support in clinical development, get in touch with us to learn how we can help.