It covers medical devices and their accessories, including any instrument, apparatus, equipment, material and other articles (including software, whether used alone or in combination), whose intended purpose for human beings 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 the anatomy or of a physiological process;

• Control of conception.

Note: Products intended to be used solely as medicinal products 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 medicinal product legislation.

In accordance with Annex IX-XI of the MDD and guidance document (MEDDEV 2.4), medical devices are classified into the following categories based on risk level, and different categories correspond to different conformity assessment routes:

1. Class I

• Class I other: Lowest risk, such as non-sterile general medical face 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 incorporating measuring functions, such as clinical thermometers.

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

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

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

*Class III with medicine: Class III devices containing medicinal ingredients, such as orthopaedic implants with antimicrobial 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 Authorized Representative (mandatory for non-EU manufacturers).

2. Product Information

• Product name, model, specification and description of differences within the product family;

• 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: Statement that the product complies with MDD and relevant harmonized 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 tests, electrical safety tests (if applicable), performance verification reports, etc.;

• Clinical evaluation data: Provide clinical literature and clinical trial reports (where applicable) according to the product risk class to demonstrate product safety and performance.

5. Quality and Production Control

• Quality management system documents (e.g. ISO 13485 certificate and relevant procedural documents);

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

6. Labelling and Instructions for Use

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

• Instructions for Use (clearly specifying operation methods, contraindications, maintenance requirements, etc.).