How to Authenticate the CE of Medical Equipment and What Materials Are Needed?

  Author:MeCan Medical–ultrasound machine manufacturers

What do you need to do for medical device CE certification? It is clearly stipulated in EU laws that all imported medical devices must be carried out by medical device CE certification. This must be passed, but there are many types of medical equipment. The equipment is roughly divided into three categories of "1, 2A, 2B, and Class 3" categories of medical devices. "CE logo can be adopted by the CE logo; The CE logo must be verified by the verification agency designated by the European Union, and the prerequisite for these types of products to obtain CE certification is that the manufacturer needs to pass the ISO9000ISO13485 quality system certification, that is, obtains the ISO9000issued by the EU's certification agency, issued by the EU, issued by the EU, issued by the EU9000 ISO13485 Quality System Certification Certificate. If you want medical device products to pass CE certification, which materials need to be prepared?

1. Do a good job in the standards and certification materials required by EU regulations on their products.

2. The technical requirements of the manufacturer are different from the EU technical regulations and EN standards.

3. The manufacturer's standard parts and maintenance quality systems are performed according to the ISO9000ISO13485 and have ISO9000ISO13485.

Medical equipment related to the health of the human body, so the European Union regulations have always been rigorous, and now there are strict regulations on the certification of medical device certification and compliance evaluation procedures that each announcement agency can engage in. When choosing an announcement agency, you must be very cautious to avoid unnecessary losses, draft a compliance statement, and add the CE logo.

How to Authenticate the CE of Medical Equipment and What Materials Are Needed? 1

recommended articles
Case Info Center AI Blog
  Author:MeCan Medical–ultrasound machine manufacturersNucleic acid automatic extraction instrument is a necessary medical device for PCR laboratory. The use of supp...
  Author:MeCan Medical–ultrasound machine manufacturersColor Doppler ultrasound is one of the important image equipment in the hospital. Color ultrasound machines ar...
  Author:MeCan Medical–ultrasound machine manufacturersMany people do not know the differences between these two kinds of non -invasive ventilator and ventilator, an...
  Author:MeCan Medical–ultrasound machine manufacturersWith the improvement of people's material living standards and the growth of population aging, the incidence o...
  Author:MeCan Medical–ultrasound machine manufacturersIn fact, we are not unfamiliar with the two equipment of color Doppler ultrasound and B -ultrasound. As people...
  Author:MeCan Medical–ultrasound machine manufacturersThe color Doppler and B -ultrasound are the way of ultrasound. Ordinary B -ultrasound is a two -dimensional ul...
  Author:MeCan Medical–ultrasound machine manufacturersAs a medical device, the "home ventilator" has gradually entered the families of many people in recent years. ...
  Author:MeCan Medical–ultrasound machine manufacturersHousehold ventilator can effectively help patients with sleep apnea. At the same time, for some patients with ...
  Author:MeCan Medical–ultrasound machine manufacturersWith the improvement of modern living standards, the proportion of fruits and vegetables in people's daily die...
  Author:MeCan Medical–ultrasound machine manufacturersThe fully automatic biochemical instrument is applied to the test of large -scale biochemical projects in the ...
no data
One-stop medical & laboratory equipment supplier,focus on medical equipments over 10 years
Contact us

If you have a question, please contact at contact info@mecanmedical.com

+86 020 8483 5259
no data
Copyright © 2021 Guangzhou MeCan Medical Limited  | Sitemap
Contact us
contact customer service
Contact us