Huizhou Foryou Medical Devices Co., Ltd.
North Shangxia Rd. Dongjiang Hi-tech Industry Park,
516005, Huizhou, PEOPLE’S REPUBLIC OF CHINA
工商备案号：粤工商备P131904000303 | 互联网药品信息服务资格证书（粤）—非经营性—2020—0083
Congratulation: Foryou Medical won the MDR certificate issued by TÜV
Congratulations to Foryou Medical for receiving the first EU CE MDR certificate for its star product Silicone Foam Dressing. This is also the first MDR certificate for Class Ⅱb Non-active non-implantable devices issued by the German Notified Body TÜV SÜD (NB 0123) (hereinafter "TÜV SÜD") to China's Advanced Wound Care Dressing industry.
On May 5, 2017, the Official Journal of the European Union published the EU Regulation on medical devices (REGULATION (EU) 2017/745, also known as MDR Regulation). The MDR regulation replaced the EU Medical Device Directive (MDD, 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD, 90/385/EEC) on May 26, 2021. After the MDR is implemented, the EU will no longer issue MDDCE certificates for new products, and the MDD certificates for old products (legacy devices) will expire on May 25, 2024, during the validity period of the certificate; that is, after that date (from May 26,2024), all products sold on the EU market will be certified in accordance with the MDR.
From "Directive" to "Regulation," the EU has increased the binding force on medical devices, and the MDR goes into effect immediately and becomes a binding law in EU member states. Compared to the old MDD regulation, the MDR has strengthened oversight, increased the difficulty and cost of certification, placed a greater emphasis on product quality and safety, and placed a greater emphasis on the compliance and technical gold content of enterprises, which has presented new challenges to businesses entering the EU.
Not only has Foryou Medical always placed a premium on regulations and quality management systems, but it also has long-term strategic plans. Since the 2017 publication of the MDR regulations, Foryou Medical has assembled an MDR conversion project team. After four years of research, exploration, and transformation, it is now well-positioned for the years to come. During the TÜV SÜD audit process, the Foryou Medical project team (Quality Department, Clinical Medicine Department, and R&D) was praised for its high level of professionalism and initiative, and TÜV SÜD recognized the team's many years of experience in the wound dressing industry.
Obtaining MDR certification is of considerable importance for Foryou Medical, which has been working in the area of advanced wound dressings for many years and has a solid reputation on the European market. It is the first crucial step for Foryou Medical to transfer all of its goods to MDR, as well as a very strong and resolute move for Foryou Medical to grow its presence on the European market and serve clients worldwide.
After that, Foryou Medical will continue to convert all goods sold on the European market to MDR compliance and provide European consumers with a rigorous quality control system.
For you, for me, for life!
*On May 22, 2019, TÜV SÜD (NB 0123) (hereinafter referred to as "TÜV SÜD"), a third-party testing and certification agency from Germany, officially obtained the new EU medical device regulation MDR [REGULATION (EU) 2017/745 ] of notified body status. TÜV SÜD Greater China can provide conformity assessment services (CE certification) under the new regulatory framework for Chinese medical device products exported to the EU. The detailed information and the scope of authorized products can be found on the EU NANDO website: http://ec. europa.eu.