Medical device CE Certification -MDR
The European Union has enforced the new medical device regulation MDR (EU 2017/745) on 26 May 2021.
According to the new EU medical device regulations "Medical Device Regulation" (2017/745, MDR) and "in Vitro Diagnostic Device Regulation" (2017/746, IVDR), the EU divides medical devices into two categories: medical device MD and in vitro diagnostic device IVD. The MDR regulations will be enforced on May 26, 2021, and the IVDR regulations will be enforced on May 26, 2022.
MD of invasive medical devices is subdivided into categories I, IIa, IIb, and III according to risk grade. Ivds of non-invasive in vitro diagnostic devices are subdivided into four categories: A, B, C, and D according to the risk level from low to high.
The new EU MDR regulations will bring problems such as increased costs, longer certification cycles and increased compliance risks to Chinese exporters. It is suggested that relevant enterprises make corresponding preparations.
First, increase the attention of the new MDR regulations and do a good job of CE certification update. CE certificates issued before the transition period are valid for no more than 5 years and expire on May 27, 2024. Applications for CE certificates after May 26, 2021 must be processed in accordance with MDR regulations and issued by authorized NB;
Second, establish quality awareness and responsibility awareness, comply with the requirements of MDR regulations, and ensure the conformity of products and standards; Third, to strengthen communication with foreign customers, clear production standards and certification requirements to avoid subsequent certification and price disputes.
MDR certification classification:
1.Class I other
2. Class I sterile
3. Class I measurement function
4. Class IIa
5.Class IIb
6. Class III and Class III with medicine
MDR certification process:
1. Receive application form
2. Sign contract
3. Plan factory audit
4. Implement factory audit
5. Issue certificate/re-audit/wait for NC non-conformance items
MDR certification technical file contains elements ：
1.Information about manufacturer (Name and address of manufacturer , Location and addresss of manufacture and design)
2. Decleration of conformity
3.European representative
4.Information about product
5.Product description,if applicable clear definition of the product models and its accessories
6. Intended use of product
7.Product label
8. Classification of the product
9. List of standards used
10. Essential requirement
11. Risk analysis
12.Product lifetime
13.Technical specifications of product
14. List of components ,specifications of used materials including confomity certificates , datasheets, test reports, information about critical suppliers.
15.Technical drawing
16. Description of product manufacturing ,special processe, flowcharts ,used recordes etc.
17. Sterilization validation data,packaging specifications
18.Biocompability conformity data
119. Product test reports
20. Software validation
21.Clinical data
Quanding Medical has submitted the materials of factory inspection and SGS inspection since early 2022, and all Class II medical supplies are about to enter the new MDR certification testing. In September this year, SGS has carried out human experimental tests on disposable negative plates for medical use, and the tests have passed. After China's Class II medical certification will be issued by the end of this year, the MDR certification of Tsuen Ding Medical is expected to pass all the tests and testing experiments in mid-23, and get the certification. The new authoritative certification process is very time-consuming, costly and energy consuming. Quanding Medical will live up to its mission and strive to produce safer and more secure medical supplies and serve our customers well.
Post time: Oct-27-2022
