ZhongZai Learning Club|CE Certification Process-"Introduction to CE Certification for Medical Devices in the EU“

1. according to the EU MDR , brief exposure (60 minutes), short-term exposure (60 minutes - 30 days), long-term exposure (more than 30 days).

2. under the EU MDR regulation, medical devices are mainly divided into four categories: Ⅰ, Ⅱa, Ⅱb, Ⅲ.

3. different certification paths are available according to different product categories.

4. CE certification requires a European representative and application to the notified body for CE certification.

5. Before certification, all work on product performance studies and verification must be completed, and the requirements of the regulations to prepare CE technical documentation.

6. need to improve the quality management system in accordance with the requirements of the MDR regulations before certification.

Group learning experience sharing.

1. on the ce certification process, the key process lies in the purpose of obtaining certification, according to different purposes to choose different announcement bodies, because different announcement bodies assessment capabilities and assessment process is not consistent, the speed and ease of obtaining certification is not the same. For example, the sales region is Southeast Asia or some less developed regions of Europe, you can choose some less well-known, cost-effective announcement agencies for review, such as sales in economically developed regions of Europe, you need to choose a higher visibility, competitive announcement agencies.

2. The classification of medical devices in these three certification methods are different, so the R & D team needs to be based on their own product classification and according to the requirements of registration and certification to further improve the information, any registration process need to learn and follow the requirements to do so to continuously improve their level.

3. CE certification process and overview, is the first contact and understanding, this class learned the classification of medical devices and different standards in different countries, but also learned the refinement of medical devices under different classifications.

Message from the Principal:

Apply what you learn, transform what you learn into your own behavior, improve your skills, implement them into your work, and ultimately improve your personal income with the amoeba way of thinking about business.