What is the difference between CE MDR and CE MDD?
 2023/12/21 | View:166


MDR is a regulation, MDD is a directive. Because it is an upgrade from directive to regulation, EU member states will implement stricter control over the certification process and results.

Mainly reflected in the following aspects:

1) Enhanced manufacturer's responsibility:

a) Manufacturers must have at least one compliance officer with professional knowledge in the field of medical devices (as not explicitly required by the MDD directive);

b) Manufacturers should establish and continuously update technical documents, and ensure that they can be provided when required by national regulatory authorities.

c) Manufacturers should always respond to flight inspections by notified bodies to ensure the updating of technical documents and the maintenance of the system; (Second class products)

d) Applying for CE will be more difficult for high-risk products from trading companies


2) Increase in regulatory provisions and stricter certification review

a) Classification rules increased: from 18 in MDD to 22 in MDR;

b) Basic requirement checklist items increased: from 13 in MDD to 23 in MDR;

c) The structure of CE technical documents has changed, divided into product technical documents and post market documents (MDD only requires product technical documents);

d) Clinical evaluation report. MDR requires companies to provide the fourth version of the clinical evaluation report, which is more stringent than the third version;


3) Expanding the scope of application

a) MDD is only applicable to products with medical purposes, while MDR includes some non medical devices in its scope of application, such as vegetable colored contact lenses, 

beauty products, etc;

b) In MDD, reusable surgical instruments are classified as a type of medical device and do not require the intervention of the notified body, while MDR requires the notified body to conduct 

compliance evaluations of repetitive surgical instruments;


4) MDR requires higher transparency and traceability

a) Introduced unique device identification (UDI) to increase product traceability;

b) The relevant information of the enterprise will be collected in the European Medical Device Database (EUDAMED);

c) Establish a post market supervision (PMS) system;

d) The announcement agency will conduct flight inspections.

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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.

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