With the regulations MDR (2017/745) and IVDR (2017/746), which 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 for their transition to clinical application.
In this article, we aim to provide an overview of the 'Impact of the Medical Device Regulation on the Development of Biomaterials,' based on the findings of a scientific study published by Jurczak and colleagues in 2024 in the journal Bioengineering & Translational Medicine.
“The new regulations not only entail compliance obligations but also structural changes concerning clinical safety and data standardization.”
— Jurczak et al., 2024
Before delving deeper, let us first familiarize ourselves with the terms MDR and IVDR.
What are MDR and IVDR in brief?
| Criterion | MDR (2017/745) | IVDR (2017/746) |
| Scope | All Medical Devices | In Vitro Diagnostic Medical Devices |
| Innovation | Clinical Evaluation, UDI System | Performance Evaluation, Reclassification |
| Objective | Enhancement 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 placing their products on the market. Within the scope of the study, this is interpreted as preliminary uncertainty for technologies not yet widely adopted, such as biomaterials.
Barriers to Clinical Implementation
A closer examination of the study reveals several barriers to clinical implementation, necessitating the development of clear solutions. These can be summarized as follows:
- Insufficient Data Standardization
The authors highlight that the available research data do not comply with MDR criteria:
- Incompatibility between Preclinical Animal Models and Human Clinical Outcomes
- Absence of Standardized Data Exchange Protocols
“Most studies concerning biomaterials do not adhere to the mandated data formats, and preclinical data are highly fragmented.”
— Jurczak et al., 2024
- Disparities in Implementation Among Member States
As noted in the article:
- Local variations in risk classification complicate the CE certification process.
- A product deemed suitable in one jurisdiction may be assigned to a more stringent classification in another.
- Innovation Impediments for Small Enterprises
- Elevated regulatory costs deter start-ups.
- Specifically, the ongoing lack of standardization for novel and composite biomaterials introduces significant uncertainty.
What solutions are proposed in this domain?
Proposed Solutions: What is Recommended?
- Safe-by-Design Approach
According to Jurczak and colleagues, product safety must be paramount:
- Biocompatibility and risk analysis must be conducted concurrently throughout the design process.
- Clinical application scenarios must be simulated during product development.
- Early Stakeholder Engagement
- Clinicians, engineers, regulatory bodies, and investors must collaborate within the same developmental process.
- This integrated approach allows for the simultaneous optimization of clinical utility, technical design, and regulatory compliance.
- Data-Driven Decision Mechanisms
- Clinical study protocols should be established in advance, aligning with regulatory expectations.
- Instead of a "one-size-fits-all solution," specific data strategies should be developed for each device class.
References
- 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