From May 2024, all devices placed on the European market must conform with the EU Medical Device Regulation (MDR)
Rousselot, the health brand of Darling Ingredients and producer of collagen products, has launched Quali-Pure, a range of gelatins for biomedical applications with controlled endotoxin levels. The range has been designed for applications including embolisation, wound healing, drug delivery, vaccines and hemostatics. The product delivers biocompatibility, biodegradability, controlled endotoxin levels and batch-to-batch consistency, the company says, and supports medical device compliance with ISO 22442 and the EU Medical Device Regulation (MDR) standards.
The gelatins also reportedly come with full traceability, documentation and viral safety.
“We are excited with this new product in our portfolio”, says Tanja Vervust, Director at Rousselot Biomedical. "It will give peace of mind to our customers who can rest assured knowing the quality, batch-to-batch consistency and purity of our Quali-Pure gelatin range will contribute to overcoming the challenges they may face on the pathway to approval of their biomedical applications.”
From May 2024, all devices placed on the European market must conform with the EU Medical Device Regulation (MDR). This regulation has replaced the existing medical devices directive (93/42/EEC) (MDD) and the active implantable medical devices directive (90/385/EEC) (AIMDD). In addition, the ISO standard 22442 has been updated to bring it further in line with global requirements for medical devices.
Quali-Pure provides supporting documentation for compliance of medical devices with the updated MDR requirements and with ISO 22442. “We design all of our biomedical gelatins with safety in mind. We aim to pro-actively support our customers towards regulatory compliance with full and documented traceability up to the farm (ISO 22442-2), validated viral inactivation (ISO 22442-3) and IPEC GMP compliance,” said Kathleen Jacobs, Regulatory Affairs Director at Rousselot Biomedical.
Quali-Pure gelatins are available from October 2021, and hydrolysed gelatins are expected to be added to the range in the near future.