Chemical safety of medical devices is essential. Topics such as biocompatibility in accordance with DIN EN ISO 10993-18

The chemical safety of medical devices is essential to protect patients and users from potential risks. The EU MDR has significantly tightened the requirements for manufacturers; chemical testing is therefore essential in order to comply with legal requirements.

In particular Biocompatibility including chemical characterisation in accordance with DIN EN ISO 10993-18, is crucial. This involves analysing medical devices and materials used therein on a risk basis in order to rule out undesirable biological reactions. Early testing prevents late changes in the development process and is also a crucial source of evidence in the event of any changes in the production process.

Further, perfluorinated and polyfluorinated alkyl substances (PFAS) are in the spotlight as they are increasingly regulated due to their environmental and health risks. In addition to existing regulations on the use of certain groups of PFAS, EU-wide restrictions on the use of all PFAS could be introduced in the near future.

Regulatory restrictions similar to those in the European Union also exist in other markets. In addition, Canada and the USA have specific reporting requirements for PFAS for certain product groups. These regulations aim to collect information on the use of PFAS and prepare for possible bans.

Manufacturers should therefore analyse their products for PFAS residues in order to demonstrate compliance with existing legislation and prepare for future restrictions.

Chemical testing not only ensures compliance with regulations, but also sustainably strengthens the quality and safety of medical devices and reduces the risk of product recalls.

Further information can be found here.