Major good news | The first high -flow MDR CE certificate in China
On April 14, the four products independently developed by Hunan BYOND Medical Technology Co., Ltd. were obtained by the EU CE MDR certificate issued by the TüV Nande will Group (TüV Nande), which was allowed to be sold in the EU market. This is the first MDR certificate to be the first high -flow respiratory and humidized therapy instrument, and it is also the first new MDR certificate in Hunan Province
The scope of this authentication includes high -flow respiratory and wetting therapy instruments and three respiratory diagnosis and treatment consumables. This also indicates thatBYONDMedical's products will represent domestic brands first to land in the European market.
The CE certification as a "access permit" as a product entering the European market is the compulsory requirement of the EU market for product access. The MDR regulations officially took effect on May 26, 2017, and forced execution on May 26, 2021, and officially replaced the current European Union's current medical device instructions (MDD, 93/42/EEC) and active implant medical device instructions (AIMDD，90/385/EEC) , After the MDR is enforced, the EU will no longer issue a MDD CE certificate for new products. From May 26th, the products sold to the EU market will be certified according to MDR. After the implementation of the MDR regulations, it will comprehensively improve the entry threshold for the EU market.