May I ask what are the testing items for medical devices (electronic blood pressure monitors) applying for FDA and CE registration and certification?

With the huge EU medical market year by year in recent years, there are more and more Chinese manufacturers who are targeting the market to the EU. Medical device products are divided into class I, II, III, class I products do not need to announce the agency involved in the issuance of certificates, only need the EU authorized representative of the enterprise to the EU authorities to do a product registration, the enterprise can be exported, class IIA and above need to announce the agency involved in the issuance of certificates (including ISO13485) and the product through the testing and issuance of CE certificates.

Medical device CE certification specific you can consult a professional testing and certification organizations, they will be based on the products you provide a specific analysis and reasonable offer, I hope the above can help you.