BioScience GmbH Receives the European Commission Approved CE Mark Extension for All Their Ranges of Hyaluronic Acid based Dermal Fillers
The extension is another exciting step in BioScience’s consistent journey of providing the safest solutions for doctors and patients around the world.
Dümmer, Mecklenburg-Vorpommern- 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 that can be used in achieving a varied number of treatment goals.
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.
This extension for BioScience Products is based on the results of the post-market clinical follow-up (PMCF).
Following previous evaluations, BioScience conducted the PMCF aiming to maintain an active collection of data on clinical experience with their dermal fillers. The new Medical Devices Regulation ties 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 increase and intensify under the new EU Medical Devices Regulation (MDR) (*), necessitating actions by companies planning to certify or gain re-certification.
The PMCF was run by BioScience for a year. 70 patients received treatment with BioScience products for a set of indications, including buttocks, hands, and calves to evaluate the safety and efficacy of the dermal fillers. The PMCF was conducted by 5 plastic surgeons from Italy and Spain, with the final report issued in June 2020.
“The extension of the CE mark is not only an important milestone for our company but also a validation to the critical need for verified products 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 ensure that.”
Other Requirements
The company also went through the full conformity assessment procedure to determine the class of its medical devices. All products receiving the declaration of conformity further established that its manufacturing adhered to all required standards.
