The materials used in the production of medical devices play a critical role in the quality of the final product. Substances that are directly in contact with the human body pose many questions regarding safety and adaptability, which are targeted by the new RDM (Regulation (EU) 2017/745), the latest European regulation on medical devices.
Effective from the 26th of May 2021 (initially 2020) this decision to delay gives medical device manufacturers another year to comply with the new European regulations. As a reminder, this aims to standardize the legislation on the marketing of medical devices between the members of the European Union. Alongside bringing in new rules, a strengthening of the scope of post-marketing surveillance and control as well as an expectation on the traceability and impact of the materials and substances used, particularly on those of the physicochemical characterization.
What are the main stakes in the management of the materials used for the manufacturing of medical devices?
Which materials are affected by this change ?
A vast array of materials and complex polymers are used in the manufacturing of medical devices. Among the most important and impacted by the new regulation changes are polymers and plastics, including polyethylene PE and polyetheretherketone PEEK. Highly used metal alloys (steel, titanium, cobalt alloy, ceramics, and composites) are also affected by this regulation change.
Biocompatibility: the main issue for materials in the manufacture of medical devices
There are many issues that are of concern to the management of materials for medical devices. The protection of patients linked to potential biological risks is currently regulated by the new European standard 2017/745. The main point of vigilance is the biocompatibility of MDs, in other words, the compatibility between medical devices and the human body. Physicochemical characterization helps limit risks by having full knowledge of all the risks that may arise, from the manufacturing of the MD to its packaging and storage.
Regarding the composition of medical devices, it is important to know precisely what the characteristics of your materials are in order to limit the risks as much as possible. With the multiplicity of data sources on your materials, it can sometimes be difficult to trace the risks. Therefore, we can only advise you to find out about a solution for managing your material data in order to best limit the risks on the composition of your MDs.
Compliance with ISO 10993
The aim of the ISO 10993 series of standards is to ensure consumer safety on medical devices. Recently updated, this series of standards specifically require MD manufacturers to set up measurement tools to confirm the absence of any biological risk for the MD user, in particular part 18 (ISO 10993-18) relating to the chemical characterization of materials mentioned above. In addition, this (relatively comprehensive) standard covers many other topics such as potential degradation products (polymers, ceramics, metals, and alloys), ethylene oxide sterilization residues, or nanomaterials.
Again, we can only advise you to equip yourself with a material data management solution. This type of solution allows complete traceability on the materials used for the manufacture of your medical devices and facilitates the selection of samples for the biological tests to be carried out on your MDs. A large part of the ISO 10993-3 standard relates to the tests and biological tests to be carried out on your samples, in particular on toxicity (genotoxicity, in vitro toxicity, systemic toxicity), and interactions with the human body (reaction in interaction with the blood, local effects after implantation of the MD).
We invite you to explore TEEXMA Materials, a materials data management software package that covers all the principles of this standard and facilitates compliance with it. By interacting with TEEXMA LIMS, our laboratory test management solution, you will be able to integrate all the technical reference points linked to the ISO 10993-3 standard and benefit from full compliance with this standard.
For more information, feel free to contact us to discuss your project, our materials experts will be able to advise you.
The BASSETTI company with its Technical Expertise Department is committed to implementing IT methods, tools, and processes to structure, archive and disseminate this high added value knowledge within the company.
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