The approach to biological evaluation for medical devices has significantly changed in the late years. Regulation (EU) 2017/745 (MDR), entered into force in 2017 and which will apply this year on May 26, stresses the importance of generating compliant, pre-clinical, biocompatibility data. Within the new regulatory framework, the release of ISO 10993-1:2018 also puts a stronger emphasis on biological safety planning, including physical and chemical characterization of medical devices.
1MED experts have just released a White Paper, now available for download, focusing on the generation of reliable data sets to support medical device biological safety.
The White Paper is intended to provide medical device manufacturers with an overview of a schematic and planned approach to biocompatibility for their products, in accordance with the requirements of the MDR and applicable standards.
The document discusses smart approaches for the generation of compliant, pre-clinical, biocompatibility data during characterization of medical devices, and strategies to minimize the unforeseen events that may occur during the laboratory phase, which may increase the risk of unnecessary and expensive repetition of tests, especially those involving laboratory animals.
Key topics discussed in this White Paper are summarized below and further addressed in the full text of the document:
- An introduction to MDR requirements for pre-clinical data, requirements regarding the responsibilities of the Manufacturer and the role of the Notified Bodies;
- The Biological Evaluation Plan as the first step in medical device characterization;
- The importance of the chemical characterization and toxicological evaluation;
- An overview on laboratory testing;
- Useful tips on how to accurately generate reliable pre-clinical data.
Interested in understanding more? Download now your free copy of 1MED’s White Paper.
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Complying with MDR provisions, where chemical, physical and biological properties of medical devices became of central importance, requires significant investments for manufacturers, as well as adequate resources and proper competencies that need to be allocated – both for initial CE-marking and for certification maintenance.
In 1MED, thanks to our extensive experience in the certification processes and to our multidisciplinary team and skilled personnel specialized in the definition of the pre-clinical and regulatory pathways for medical devices, we can help you establish an efficient strategy for the generation of reliable data sets to support the biological safety of your medical devices.
Thanks to our collaboration with 1LAB, we can also support you in the design and conduction of several pre-clinical tests.