Requirement Mapping
| Medical Device Regulation (MDR) | Document Section |
|---|---|
| Annex VIII | (All) |
Associated Documents:
- Intended Use
- SOP Product Certification and Registration
Overview
| Product: | (Enter content) |
|---|---|
| Version: | (Enter content) |
| Classification: | (Enter content) |
| Rule: | (Enter content) |
Justification for classifying the product as a medical device (per MDR Annex II, Section 1.1.e):
Refer to the Intended Use Statement.
Chapter 1: Relevant Definitions
Ensure all rows below are reviewed thoroughly. Some have been pre-filled under the assumption of standalone software as a medical device. However, verifying each detail carefully is essential for compliance.
1. Duration of Use
| Term | Definition | Applicable |
|---|---|---|
| Transient | Intended for continuous use for less than 60 minutes. | |
| Short-term | Intended for continuous use of no more than 30 days. | |
| Long-term | Intended for continuous use exceeding 30 days. | |
2. Invasive and Active Devices
| Definition | Applicable |
| ———- | ———- |
| 2.1 Body orifice: Any natural opening in the body, including the eyeball surface, or any permanent artificial opening such as a stoma. | No |
| 2.2 Surgically invasive device:
(a) Penetrates the body via the surface or mucous membranes during surgery.
(b) Produces penetration other than through a body orifice. | No |
| 2.3 Reusable surgical instrument: A surgical tool for cutting, drilling, or similar functions, intended for reuse after sterilization. | No |
| 2.4 Active therapeutic device: Used to support or restore biological functions for treatment or alleviation of conditions. | |
| 2.5 Active diagnostic and monitoring device: Supplies information for detecting, diagnosing, or treating physiological conditions. | |
| 2.6 Central circulatory system: Includes blood vessels such as the aorta and vena cava. | |
| 2.7 Central nervous system: Includes the brain, spinal cord, and meninges. | |
| 2.8 Injured skin or mucous membrane: Areas with pathological changes due to disease or injury. | |
Chapter 2: Implementation of Rules
| Rules | Applicable |
|---|---|
| 3.1: Classification is governed by the device’s intended purpose. | Yes |
| 3.2: Devices used in combination are classified separately, including accessories. | |
| 3.3: Software driving or influencing a device inherits its classification; standalone software is classified independently. | |
| 3.4: Devices not limited to specific body parts are classified by their most critical use. | |
| 3.5: If multiple rules apply, the strictest one resulting in a higher classification is used. | |
| 3.6: Continuous use includes interrupted use for cleaning or similar reasons, considered cumulatively. | |
| 3.7: Devices allowing direct diagnosis must provide conclusive diagnostic information. |
Chapter 3: Classification Rules
4. Non-Invasive Devices
| Rule | Applicable |
|---|---|
| Rule 1: Non-invasive devices are Class I unless specified otherwise. | |
| Rule 2: Non-invasive devices for channelling or storing body fluids are Class IIa if used with active Class IIa or higher devices. | No |
| Rule 3: Devices altering biological or chemical compositions for implantation or administration are Class IIb, except in certain cases (e.g., filtration). | No |
| Rule 4: Devices for contact with injured skin are Class I, IIa, or IIb, depending on use. | No |
5. Invasive Devices
| Rule | Applicable |
|---|---|
| Rule 5: Non-surgically invasive devices are classified based on duration and connection to active devices. | No |
| Rule 6: Surgically invasive devices intended for transient use are generally Class IIa, with exceptions (e.g., heart contact devices). | No |
| Rule 7: Surgically invasive devices for short-term use follow similar classifications as Rule 6. | No |
| Rule 8: Implantable devices are Class IIb, with exceptions for critical body parts or specific functions. | No |
6. Active Devices
| Rule | Applicable |
|---|---|
| Rule 9: Active therapeutic devices are Class IIa unless they administer energy hazardously (Class IIb). | |
| Rule 10: Diagnostic active devices are Class IIa unless involving immediate patient danger or certain functions (Class IIb). | |
| Rule 11: Software for diagnostic or therapeutic decisions is Class IIa, IIb, or III depending on the impact of its use. | Yes |
| Rule 12: Devices administering substances are Class IIa unless the method is potentially hazardous (Class IIb). | |
| Rule 13: All other active devices are Class I. |
7. Special Rules
| Rule | Applicable |
|---|---|
| Rule 14: Devices incorporating medicinal substances are Class III. | No |
| Rule 15: Contraceptive devices are Class IIb, with implantable ones as Class III. | No |
| Rule 16: Devices for disinfecting medical equipment are Class IIa or IIb. | No |
| Rule 17: X-ray diagnostic image recorders are Class IIa. | No |
| Rule 18: Devices utilizing non-viable human/animal tissues are typically Class III. | No |
| Rule 19: Devices with nanomaterials are classified based on exposure potential (Class IIa to III). | No |
| Rule 20: Inhalation devices for administering medicinal products are Class IIa or IIb based on impact. | No |
| Rule 21: Devices absorbed or dispersed in the body are Class IIa, IIb, or III, depending on their effects. | No |
| Rule 22: Therapeutic devices with integrated diagnostics influencing patient management are Class III. |