Biological evaluation
All medical devices in the EU are subject to a conformity assessment. This begs the questions “conformity with what?”. For this, the MDR presents a generally valid catalogue of requirements, whose application and implementation has to be discussed for each individual product – the General Safety and Performance Requirements (GSPR) from MDR Annex I.
GSPR 10.4.1 demands from the manufacturers to discuss the biological risks of their own products. Fortunately some (but not all) parts of the extensive series of standards ISO 10993 has been added to the harmonized standards.
To evaluate the biological risks of a product in context of a norm and MDR conforming “biological evaluation” the following questions have to be answered:
- Which materials are the components of my product made from?
- What kind of (body) contact do these materials/components have?
- How long is this contact and is a cumulative contact relevant to the evaluation?
From a combination of these factors the so called “Endpoints” for the biological evaluation become clear. It’s important to know that a plethora of argumentative approaches and data sources are available to discuss these endpoints. These can be practical tests, e.g. cytotoxicity, irritation, toxicity, hemocompatibility and genotoxicity. However, it is also possible to use data from literature, material databases and clinical applications.
Together (with you) we apply these rigid and vague terms and norm requirements to your products, combine the endpoints to be taken into account with the available data and identify if possible gaps have to be addressed by specific tests.
Our services for the biological evaluation consists of:
- Transfer of knowledge: Normative requirements are brought down to earth (your product reality) in a workshop format.
- Document creation: Together with you we develop the biological evaluation and discuss how far the available data can carry us.
- Follow-Up: The interpretation of requirements is rarely an exact science – Together we tackle the notified bodies inquiries.
