With the regulations MDR (2017/745) and IVDR (2017/746) that came into force in 2021, the European Union significantly tightened the safety and transparency criteria for medical devices. This introduced a series of new demanding conditions for researchers developing biomaterial-based products to transition to clinical application.
In this article, we would like to give you an overview of the „Impact of the Medical Device Regulation on the Development of Biomaterials“, based on the results of a scientific study published by Jurczak and colleagues in 2024 in the journal Bioengineering & Translational Medicine.
„The new regulations not only bring compliance obligations but also structural changes regarding clinical safety and data standardization.“
— Jurczak et al., 2024
Before we delve deeper into this, let us first familiarize ourselves with the terms MDR and IVDR.
What are MDR and IVDR in a nutshell?
| Criterion | MDR 2017/745 | IVDR (2017/746) |
| Scope | All medical devices | In-vitro diagnostics |
| innovation | Clinical evaluation, UDI system | Performance demonstration, reclassification |
| Objective | Improvement of patient safety | Ensuring diagnostic accuracy and traceability |
According to the latest regulations, clinical data collection is now an indispensable prerequisite for the approval of medical devices. Furthermore, manufacturers must submit systematic risk analyses and performance data before market introduction of their products. Within the study, this is interpreted as provisional uncertainty for not yet widely spread technologies such as biomaterials.
Barriers to clinical implementation
Upon closer examination of the study, it becomes clear that clinical implementation is confronted with some barriers and that clear solutions need to be found in this regard. These can be summarized as follows:
- Lack of data standardization
The authors emphasize that the existing research data do not meet the MDR criteria:
- Incompatibility between preclinical animal models and clinical results in humans
- Lack of common protocols for data exchange
„Most studies on biomaterials do not correspond to the prescribed data formats, and the preclinical data are very fragmented.“
— Jurczak et al., 2024
- Differences in implementation between member states
As mentioned in the article:
- Local differences in risk classification complicate the CE certification process.
- A product classified as suitable in one country may be assigned a stricter class in another country.
- Innovation barriers for small businesses
- High regulatory costs have a deterrent effect on start-ups.
- In particular, the not yet completed standardization of new and composite biomaterials represents an uncertainty.
What solutions are proposed in this area?
Proposed solutions: What is recommended
- Safe-by-design approach
According to Jurczak and colleagues, product safety must come first:
- Biocompatibility and risk analysis must be promoted in parallel in the design process.
- Clinical application scenarios must be simulated in product development.
- Early involvement of stakeholders
- Clinicians, engineers, regulators and investors must come together in the same process.
- In this way, clinical benefits, technical design and legal conformity can be jointly optimized.
- Data-based decision-making mechanisms
- Clinical study protocols should be determined in advance in accordance with regulatory authorities' expectations.
- Instead of a “unit solution”, specific data strategies should be developed for each device class.
Sources
- Jurczak, B., Dankers, P.Y.W., Blokzijl, M.M., & Van Rijn, C.J.M. (2024). Recent regulatory developments in EU medical device regulation and their implications for the clinical translation of biomaterials. Bioengineering & Translational Medicine, E10721. https://doi.org/10.1002/btm2.10721
- MDR 2017/745 & IVDR 2017/746: eur-lex.europa.eu
- European Commission: health.ec.europa.eu