Covering medical devices and their accessories, including any instruments, apparatus, equipment, materials and other articles (including software, whether used alone or in combination), whose intended purpose for the human body is as follows:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease;

• Diagnosis, monitoring, treatment, alleviation or compensation for an injury or disability;

• Investigation, replacement or modification of an anatomical or physiological process;

• Control of conception.

Note: Products intended solely for medicinal use are excluded. However, where a device is combined with a medicinal product (e.g. drug-device combination product), it shall comply with both the requirements of MDD and relevant pharmaceutical regulations.

In accordance with Annexes IX-XI of MDD and guidance document MEDDEV 2.4, medical devices are classified into the following categories based on risk levels, with different conformity assessment routes applicable to each category:

1. Class I

• Class I other: Lowest risk, such as non-sterile general medical masks, non-sterile medical examination gloves, etc.;

• Class I sterile: Class I products subject to sterilization treatment, such as sterile medical gauze;

• Class I with measuring function: Class I products equipped with measurement functions, such as clinical thermometers.

2. Class IIa: Medium risk, such as sphygmomanometers, hearing aids, etc.;

3. Class IIb: Medium-high risk, such as dialysis equipment, electrocardiographs, etc.;

4. Class III: High risk, such as heart valves, implantable defibrillators, etc.;

*Class III with medicinal products: Class III devices containing medicinal ingredients, such as orthopaedic implants with antibacterial agents.

Technical documentation is the core of MDD certification and shall contain the following key contents (to be compiled in an official EU language):

1. Manufacturer Information

• Name and address of the manufacturer, addresses of design and production sites;

• Name and address of the EU Authorized Representative (mandatory for non-EU manufacturers).

2. Product Information

• Product name, model, specifications and description of differences across the product series;

• Description of intended purpose, target population and operating environment of the product;

• Product design drawings, bill of materials and manufacturing process documents.

3. Proof of Compliance

• Declaration of Conformity: a statement certifying that the product complies with MDD and relevant harmonised standards;

• Risk analysis report: assessment of potential product risks and control measures in accordance with ISO 14971.

4. Performance and Safety Data

• Test reports, including biocompatibility test, electrical safety test (if applicable), performance verification reports, etc.;

• Clinical evaluation data: clinical literature and clinical trial reports (where applicable) shall be provided based on the product risk class to demonstrate product safety and performance.

5. Quality and Production Control

• Quality management system documents (such as ISO 13485 certification certificate and relevant procedure documents);

• Production process control records, inspection specifications and batch test reports of products.

6. Labelling and Instructions for Use

• Product labels (must bear CE marking, product reference number, manufacturer information, etc.);

• Instructions for Use (shall clearly specify operating methods, contraindications, maintenance requirements, etc.).