What is the difference between MDD and MDR classification?
 2023/12/27 | View:264

From MDD to MDR, instruments are still divided into four categories: 

Class I, Class IIa, Class IIb, and Class III.

The classification related MDD is Annex IX in 93/42/EEC and the corresponding guidelines MEDDEV 2 4/1 Rev. 9; 

Article 51 and Annex VIII in the new MDR provide detailed product classification information. The main change is from "18 items" in MDD to "22 items" in MDR.

Rule1-Rule 4: Non Invasive Devices

Rule3: Added Class III instruments for directly removing human cells, tissues, and trachea from the human body or embryo for external use, and then implanting or injecting them into the body.

Rule 5-Rule 8: Invasive Devices

Rule 8: On the basis of the original, active implant instruments or their related accessories, breast implants or heart repair mesh fabrics, complete or partial joint replacements, and intervertebral disc 

replacement implants directly in contact with the spine have been added as Class III.

Rule 9-Rule 13: Active Devices

Rule9: On the basis of the original, "active devices for releasing ionizing radiation for mitigation purposes" and "active implantable devices for controlling, monitoring, or directly affecting" have been added,

 both of which are Class IIb devices.

Rule11: Newly added, proposing software for providing diagnostic or mitigation purpose decision information and monitoring physiological processes, all of which are Class IIa; Other software classes are 

classified as Class I.

Rule 14 Rule 22: Special RULES

Rule14: Further improved the classification requirements for medical products derived from human blood or plasma.

Rule 18: Further improve the classification requirements for devices made from inactive or processed human or animal derived tissues, cells, or other derivatives.

Rule19: Add classification requirements for nanomaterial instruments.

Rule20: Added classification of invasive instruments related to body orifices through inhalation.

Rule 21: Added instruments that introduce absorbable substances into the human body.

Rule22: Added classification of active relief devices with integrated or merged diagnostic functions.

In addition, the separate classification of blood bags in MDD has been removed.


Get In Touch

Quick Response within 24 hours!


Contact Us

  • 电话Tel: (+)86-519-88168398

  • whatsappWhatsApp: +86-13961432323

  • 邮箱Email: sale01@lelun.com

  • 地图HengShanQiao Town, out of East Gate, Changzhou ,Jiangsu, China

About Us

Changzhou Medical Appliances General Factory Co., Ltd. was built in 1988, it is a modern factory specialized in producing the disposable medical appliances in China. The factory is only 1km to Hengshan entrance of Huning high-speed road and is about 20 miles to Changzhou airport. So the traffic is convenience.
The area of the factory is 40000㎡, the area of purifying workshop is 7000m, and fixed assets are about 5,000,000USD. Our main products are Disposable infusion sets, Disposable blood transfusion sets, Disposable Sterile syringe sets, latex glove, disposable infusion set, simple oxygen mask, nebulizer mask, urine cup, hernia mesh, urine bag etc. Now we can manufacture more than 200,000,000 sets per year.

CopyRight © 2023-2024   Changzhou Medical Appliances General Factory Co.,Ltd  All rights reserved   Sitemap   All tags   Designed by Zhonghuan Internet
Get The Latest Product Information
From the beginning, we puts customer service first around the world, the most professional processor and supporters you can trust. This is our comprehensive commitment to quality.
Company Name
This field is required
This field is required
Email format error
This field is required
Telephone information is wrong!
This field is required
Send Message