Biological Evaluation from the Perspective of Clinical Evaluation According to the MDR
18/12/2023
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The clinical evaluation of a medical device is an essential part of the Technical Documentation, assessing compliance with the General Safety and Performance Requirements outlined in Annex I of the Medical Device Clinical Evaluation
The identification and detailed description of the medical devices under evaluation and their clinical application are found at the beginning of each Clinical Evaluation Plan (CEP) and the accompanying Clinical Evaluation Report (CER). These initial sections specify the document's scope concerning the covered products, explaining the composition (structure) and peculiarities of the application of the medical devices under evaluation.Starting Point for Biological Evaluation
According to point 1.1k) in Annex II of the MDR , listing substances that come into direct or indirect contact with the human body is also part of the product description. These, along with the respective tissue type and contact duration and type, are listed in the early chapters of the clinical evaluation plan. This information serves, among other purposes, as the starting point for the biological evaluation strategy, which is defined in the biological evaluation plan.The ingredients of the medical device are cross-referenced with the list of substances of very high concern for authorization under the REACH regulation (SVHC list) and checked for the safety of application for medical purposes during material characterization. Annex A ofBiocompatibility
For all medical devices intended for direct contact with the human body, proof of the biocompatibility of ingredients or used materials is essential. The tests provide, as required by Annex A ofHolistic Biological Evaluation
From the perspective of clinical evaluation creators, documenting the biological assessment in the form of a biological evaluation plan and its corresponding report for the product group under evaluation is much more manageable than dealing with individual reports according to different parts ofBiological Evaluation and Equivalence of Medical Devices
Another part of the clinical evaluation where data from biological evaluation are relevant is the comparison of biological characteristics to demonstrate equivalence between two medical devices. The relevant biological characteristics for equivalence are specified in- Same materials or substances in contact with the same human tissue or body fluids
- Similar type and duration of contact
- Similar release properties of substances, including breakdown products and leachable substances
Conclusion
The interfaces between biological and clinical evaluation are outlined above, highlighting their close interconnection. In practice, it is crucial to complete the biological evaluation before commencing the creation of the clinical evaluation. If this sequence is not followed, it can lead to unnecessary efforts, for example, if the biological evaluation reveals obvious safety gaps in the used substances.Do you need assistance with creating the clinical evaluation or biological evaluation for your medical device? Or are you currently dealing with another complex issue related to Clinical Affairs or Technical Documentation and are in search of experienced professionals? Please feel free to contact us anytime. Together, we will find the best solution for your specific needs.Best RegardsOleg Repp
Oleg Repp |
Medical Device Expert Clinical Affairs & PMCF |
oleg.repp@metecon.de |