MEDICAL | MATERIALS
Peter Mapleston looks at developments from materials producers working to meet the medical sector’s tough demands
Suppliers help moulders in regulation and performance
There is probably no industry of importance to the plastics injection moulding community that is more regulated than medical and healthcare. And it is just about to get more regulated. The European Union Medical Device Regulation will be fully implemented in May next year after coming into force in 2017. It will replace two existing directives on medical devices, the Medical Devices Directive from 1993 and 1990’s Active Implantable Medical Device Directive [90/385/EEC]. The European Commission expects the Medical
Device Regulation (MDR) to improve the quality, safety and reliability of medical devices, while also strengthening the transparency of information for consumers, and enhancing vigilance and market surveillance. The MDR fundamentally changes the way medical devices will be regulated in the future. The changes to legislation it involves could impact the entire supply chain. Under the MDR, all of the actors in the supply chain will, for the first time, have potential responsi- bility for defects in devices – previously the regula-
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tions focused solely on manufacturers. In addition, manufacturers outside the EU will need EU-based authorised representatives. Materials companies try to keep in tune with changes in regulations like the MDR, of course. A typical example is Borealis and its joint venture Borouge (which handles business in Middle East, Asia Pacific, the Indian sub-continent and Africa), which recently introduced Bormed BJ868MO, a high flow, heterophasic polypropylene copolymer intended for production of medical and diagnostic devices. Borealis says the new product is “an important extension of the dedicated Borealis Bormed portfolio of polyethylene and polypropyl- ene products.” Validation of Bormed BJ868MO was carried out in co-operation with Premix, a leading producer of electrically conductive plastics, some of which are used in healthcare applications, and a leading medical diagnostics company. Borealis says that Premix compounds have been used in automated liquid handling applications since the early 1990s.
Main image: Thermoplastics with very good friction properties are critical for such products as insulin pens
� March 2019 | INJECTION WORLD 15
PHOTO: SABIC
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