Some major changes include: 1. Expansion of product range. The definition of medical devices and active implantable medical devices will be greatly expanded to include devices that do not have a medical purpose and devices designed to predict "disease or other health conditions."
1. Expansion of product range. The definition of medical devices and active implantable medical devices will be greatly expanded to include devices that do not have a medical purpose and those that are designed to predict. Equipment for disease or other health conditions;
2. Reclassify equipment according to risk, contact time and invasiveness. The MDR will require device manufacturers to review updated classification rules and update their technical documentation accordingly, taking into account that class and implantable devices will have higher clinical requirements and regular review procedures;
3, more stringent clinical evidence for class III and implantable medical devices. If the manufacturer does not have sufficient clinical evidence to support the safety and performance requirements of the specific device, the manufacturer will be required to conduct clinical studies;
4. Systematic clinical evaluation of Class IIa and Class IIb medical devices. Manufacturers will need to reprepare their clinical assessments by considering new wording of the regulations that address when an equivalent approach is applied and under what circumstances a clinical study is justified;
4, more stringent documentation;
5, confirm ” People responsible for compliance ” ;
6, implement unique equipment identification to achieve better traceability and recall;
7, more stringent monitoring by notified bodies to reduce the risk of unsafe equipment;
8, strengthen the review of notified bodies;
9, no ” Grandfather rules. All currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements.
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