Ce-mark-medical-device In order to market medical devices in the EU, a CE mark certificate is required. This certification confirms that a product has met all regulations in place for medical devices. When the regulations come into play on May 2020, only those who comply with the MDR will attain this certification. However, given that a CE accreditation lasts for 5 years, the last ones to expire under the MDD regulations will do so on 25 May, 2024.
The changes introduced in the MDR affect a variety of aspects in the CE marking process. Some of these processes include device classification, technical file documentation, and post-market activities. The goal of this is to increase the qualitative standards of medical devices within the EU, ensuring improved levels of safety whilst encouraging innovation (kolabtree, 2017).
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
