With bioplastics, we create a livable world by developing, manufacturing and marketing products that are sustainable for people and the environment in the long term.

In order to bring functional, reliable and at the same time environmentally compatible materials to the market, care for the quality of our products is always the first priority. With the regular certification of our quality management system and all related product manufacturing processes according to DIN EN ISO 13485, we are expanding the application possibilities of bioplastics to the life sciences.

Medical Grade Plastics (MGP) are polymeric plastics and masterbatches, blends, compounds which [...] are used to produce [...]

>> Medical devices (according to MDR – Regulation (EU) 2017/745)

>> In vitro diagnostics (according to IVDR – Regulation (EU) 2017/746) 

>> Primary packaging (according to the guidelines of the European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) and Committee for Medicinal Products for Veterinary Use (CVMP))

When supplying medical grade bioplastics to our customers, we maintain a certified quality management system “that shall ensure compliance with [the MDR] in the most effective manner and in a manner that is proportionate to the risk class and the type of device” (MDR, Article 10(9)).

It is certified in accordance with the harmonized ISO 13485 standard to support the fulfilment of the ‘General Safety and Performance Requirements’ (MDR, Annex I).

This ensures that products with reproducible quality properties can be produced at any time using our bioplastics.

In the development and manufacture of Medical Grade Bioplastics, we comply with the requirements of Annex I Sections 10.1 and 10.4.1 of the MDR applicable to materials:

>> The mass proportion of carcinogenic, germ cell mutagenic and reproductive toxic substances of category 1A or 1B according to EU Chemicals Regulation (EC) No. 1272/2008 (CLP) of 28.10.2020 is less than 0.1% in our products.

>> The mass proportion of substances of very high concern published in accordance with Article 59(10) of the REACH Regulation (EC) No. 1907/2006 of 18.12.06 is less than 0.1% in our products.

>> Bioplastics in medical grade quality have been subjected to assessment and evaluation in accordance with ISO 10993 to confirm basic biocompatibility.

According to Regulation (EC) No. 1272/2008 (CLP), the bioplastics of BIOVOX are classified as "non-hazardous". According to Article 31 of the REACH Regulation (EC) No. 1907/2006 of 18.12.06, a safety data sheet is therefore not required for them.

In accordance with Article 32, we will provide you with all information necessary for safe handling, to ensure safety or for your risk management measures. In accordance with Article 32, we will provide you with all information necessary for safe handling, to ensure safety or for your risk management measures. Just contact us!

Quality acc. to >>ISO 13485

Biocompatibility according to ISO 10993 product-specific on request.