Medical devices have revolutionized the field of medicine and continue to do the same today. Whilst using them comes with numerous advantages, there are some materials present in their composition which can harm the human body to a dangerous extent. Phthalates have been used in the industrialization processes for a long time as plasticizing agents and today, they are among one of the most important constituents which are being used in some medical devices. While having this much importance, they are classified under the categories:
- CMR phthalates; where CMR stands for Carcinogenic Mutagenic and toxic to Reproduction
- ED phthalates; where ED stands for Endocrine Disrupting phthalates
As the names suggest, these chemical compounds can cause very serious threats to the human body once they get inside. They can detach from the device since they have weak bonds with their polymers. This physical property leads them to get away from their bonding with polymers easily and thus intruding inside the human body after which they start to disrupt the normal body processes.
The EU with the issuance of its new MDR has made it compulsory for every reality where the composition of the phthalates in a medical device becomes greater than 0.1% w/w then a comprehensive Benefit-Risk Analysis is needed to establish the integrity of phthalates regarding their use in the medical devices as well as to look for their safe and suitable alternatives.
TS Quality and Engineering is an ISO 13485 certified company that offers solutions in the areas of testing, regulation, design, validation, and other quality control processes. We have been performing Benefit-Risk Analysis for the manufacturers of medical devices all across Europe who wants to use phthalates in their medical devices. We are also providing intellectual help to identify alternatives for phthalates (where possible).
It does not matter if you are a manufacturer of medical devices willing to market his medical devices containing phthalates or if you are looking for safe alternatives for your medical devices because we at TS Quality and Engineering will conduct a proper BRA Analysis for your medical device so that you can market your device in the Union without any challenges.
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