Pinneberg/Germany, September 11th, 2019 - The health and medical device industry is subject to very strict regulations to ensure the highest quality and safety. Consequently, product development is both complex and time-consuming, and is accompanied by many conformity regulations, long-term tests, quality tests and certifications. ROMIRA is optimally prepared for these special conditions and can provide customised compounds for diagnostic devices in hospitals and laboratories.
Manufacturers of medical devices face a variety of risks and challenges: For instance, once they have selected and tested a material that meets all the stringent regulations and requirements for medical plastics, they must be able to rely on long-term availability and planning. A new material release procedure, including a certification process, is complicated, expensive and often extremely time-consuming.
The fact that medical device manufacturers are not regulated in the selection of polymers and are left to decide for themselves is also problematic. The upcoming EU regulation on medical devices (MDR - 2017/745), which will come into force on May 26, 2020, attaches great significance to risk management and product safety, but does not regulate the selection of materials. In comparison to previously applicable directives, it contains a large number of new articles, rules and requirements - but does not contain any statements on the materials.
The final version of VDI Directive 2017 "Plastics in Medical Technology", published in July 2019, is a meaningful supplement to the existing regulations. The scope of the directive covers the composition and consistency of formulations of plastics, including blends, compounds and masterbatches.
ROMIRA considers itself a partner of the healthcare industry and offers customised compounds for medical and laboratory technology. The extensive product range is based on a multitude of different engineering plastics, selected colorants and high-performance fillers: such as the flame-retardant PC/PBT blend ROMILOY 5130/01 or the flame-retardant PC/ASA blend ROMILOY 8170, both of which are already used in numerous medical device applications.
ROMIRA safeguards these products through uniform formulas, committed change management and support with official approvals. The required raw materials are also secured by a "second source" policy. This has been verified several times in external and internal audits according to ISO 13485 or 21 CFR Part 820. This demonstrates a significant added value which is highly appreciated by ROMIRA customers.