BioScience GmbH announced the extension of the CE mark for all of the ranges of their hyaluronic acid dermal fillers: HYAcorp, Genefill and Hyaprof.
This achievement continues to set the Germany-based organization apart as the only manufacturer in the world holding the CE mark for the body dermal fillers in addition to face products. The certified complementary portfolio gives a whole spectrum of options of monophasic (monodensified and polydensified) and biphasic dermal fillers for face and body. They can be used in a varied number of non-invasive augmentation and contouring treatments, with the ensured efficacy, tolerability, easiness of injection and long-lasting effect.
The CE Mark Extension for BioScience
Issued by the European Commission, the CE mark signifies that a product sold in the European Economic Area has been assessed to meet the highest safety, health, and environmental protection requirements.
The extension of the CE mark for BioScience is based on the results of post market clinical follow-up (PMCF).
Following previously done clinical evaluations, BioScience conducted the PMCF with the aim of an active collection of data on clinical experience with their dermal fillers. The requirements of the new Medical Devices Regulation tie the PMCF data more closely to post-market surveillance and clinical evaluation report requirements. Requirements for manufacturers to provide clinical data obtained via the PMCF are set to both increase and intensify under the new EU Medical Devices Regulation (MDR) , necessitating additional activities by companies planning to certify or gain re-certification under the new regulation.
The post market clinical follow-up was run by BioScience over the course of one year. 70 patients received treatment using BioScience products for a set of indications including buttocks, hands and calves in order to evaluate the safety and efficacy of dermal fillers. The PMCF was conducted by 5 plastic surgeons from Italy and Spain; the final report has been issued in June 2020.
“The extension of our CE mark is not only an important milestone for the company, but it also validates the critical need for verified dermal fillers in the aesthetics industry,” said Dr. Eyad Al Mchrif, CEO of BioScience. “We believe that the growth of our industry should be primarily about the quality, not quantity and only demanding legislation and tight regulations can boost confidence in it.”
In the process of obtaining the CE mark, BioScience also fulfilled a set of regulations required for their complete ranges of products.
The company went through the full conformity assessment procedure to determine the class of their medical devices. Declaration of conformity has been received for all the products and states that all dermal fillers have been manufactured under consideration of the respective directive and applicable standards.
Moreover, according to the requirements of the new MDR, the quality management system of the manufacturing standards used during the production of BioScience products has been accredited by a notified body with DIN EN ISO 13485.
The intended purpose for all of the BioScience dermal fillers, which decided on the application of regulations and directives, is set as soft tissue augmentation. It has been confirmed for all hyaluronic acid formulas in the products, both biphasic and monophasic, including non-modified (non-cross-linked) hyaluronic acid gel, modified hyaluronic acid gel, cross-linked hyaluronic acid gel with dextranomer, cross-linked cohesive hyaluronic acid gel.
The intended use of BioScience dermal fillers has been also confirmed to further define the user context, environmental conditions, storage and transportation conditions, cleaning, updates, maintenances – so included the entire product lifecycle.
BioScience received the initial CE mark in 2006 and has been renewing it regularly since then.
“CE mark confirms our commitment to producing high-quality products and ensures that our customers will continue to have a safe, non-invasive treatment option for both face and body,” added Dr. Eyad Al Mchrif.
(*): According to the EU Medical Devices Regulation (MDR), which entered into force on 26th May 2017 and replaced the EU’s Medical Devices Directive (MDD) (93/42/EEC) and Active Implantable Medical Device Directive (AIMDD) (90/385/EEC) with a 3-year transitional period, all dermal fillers are now being classified as medical devices. The new directive classifies injectable dermal fillers with hyaluronic acid as the highest risk class – III, which refers to medical devices with absorbed ingredients.