Part 3: Invasive Devices
Definition of Invasive devices
The MDR defines the term “invasive device” as “any device which, in whole or in part, penetrates inside the body,
either through a body orifice or through the surface of the body”
This definition is a bit complex as it covers a combination of several different conditions. Additionally the definition of “body orifice” in chapter 1 of the classification rules as “any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.”
The definition deserves some attention as for example body piercings might penetrate an (permanent artificial) body orifice. No further definition is given. “Such as a stoma” is unclear as it lacks criteria for the equivalence. Hopefully there will be a clarification before the final deadline May, 25th 2020.
Bad news first
In case the invasive device may come into contact with injured mucous membrane the classification is to be done following rule 4!
Please be advised to document your classification accordingly.
Four rules AND a lot of exemptions
Rule 5
Rule 5 is not relevant for devices that penetrate inside the body through the surface of the body. This means that all surgical devices are excluded from this rule. Rule 5 applies to devices that are not intended to be connected to an active device. Additionally rule 5 does apply to devices that are intended to be connected to an active class 1 device.
Rule 5 also contains some quirks that need to be treated carefully. The second and third sub-rule contain exceptions. So if you start reading and think “this is class 2a” you need to continue reading as it might turn out that you have a class 1 device. Similar in the third sub-rule where you might think “a class 2b!” but in case the exception is valid you have a class 2a device.
This is simplified in the MDR classification tool that you can find here.
The good news: There is no class 3 under rule 5.
Rule 6
Rule 6 surprises with six exceptions to one rule. This is a bit unfortunate. I recommend to start with the evaluation of the sub-rules to exclude that one of them applies. Although on first sight it seems a cosmetic change you will soon experience the easier and faster understanding of cleanly rewritten rules here:
- 6.1 Surgical invasive devices that are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body are classified as class 3.
- 6.2 Surgical invasive devices that are reusable surgical instruments are classified as class 1.
- 6.3 Surgical invasive devices that are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system are classified as class 3.
- 6.4 Surgical invasive devices that are intended to supply energy in the form of ionising radiation are classified as class 2b.
- 6.5 Surgical invasive devices that have a biological effect or are wholly or mainly absorbedare classified as class 2b.
- 6.6 Surgical invasive devices that are intended to administer medicinal products by means of a delivery system, if such administration of a medicinal product is done in a manner that is potentially hazardous taking account of the mode of application are classified as class 2b.
- 6.7 All other surgical invasive devices that are intended for transient use are classified as class 2b.
To maintain compatibility with the original MDR you will find the original order in the MDR classification tool but may refer to the above list for simplification.
Rule 7
Rule 7 also consists of one main rule and six exceptions. The recommendations for rule 6 apply as well.
To give a solid reference the single rules are here:
- 7.1 Surgical invasive devices that are intended specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with those parts of the body are classified as class 3.
- 7.2 Surgical invasive devices that are intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system are classified as class 3.
- 7.3 Surgical invasive devices that are intended to supply energy in the form of ionizing radiation are classified as class 2b.
- 7.4 Surgical invasive devices that have a biological effect or are wholly or mainly absorbed are classified as class 3.
- 7.5 Surgical invasive devices that are intended to undergo chemical change in the body and are not placed in the teeth are classified as class 2b.
- 7.6 Surgical invasive devices that are intended to administer medicines are classified as class 2b.
- 7.7 All other surgical invasive devices that are intended for short-term use are classified as class 2a.
Rule 8
Rule 8 is far more complex than rules 6 and 7. Rule 8 consists of one main rule and 10 exceptions. To avoid uncertainty it is vital here to rearrange the rules and start the assessment with the “exceptions”.
Below you find the list of the exceptions and the general rule at the end:
- 8.1 Implantable devices and long-term surgical invasive devices that are intended to be placed in the teeth are classified as class 2a.
- 8.2 Implantable devices and long-term surgical invasive devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system are classified as class 3.
- 8.3 Implantable devices and long-term surgical invasive devices that have a biological effect or are wholly or mainly absorbed are classified as class 3.
- 8.4 Implantable devices and long-term surgical invasive devices that are intended to undergo chemical change in the body and are not placed in the teeth are classified as class 3.
- 8.5 Implantable devices and long-term surgical invasive devices that are intended to administer medicinal products are classified as class 3.
- 8.6 Implantable devices and long-term surgical invasive devices that are active implantable devices or their accessories are classified as class 3.
- 8.7 Implantable devices and long-term surgical invasive devices that are breast implants or surgical meshes are classified as class 3.
- 8.8 Implantable devices and long-term surgical invasive devices that are total or partial joint replacements and are not ancillary components such as screws, wedges, plates and instruments are classified as class 3,
- 8.9 Implantable devices and long-term surgical invasive devices that are spinal disc replacement implants and are not ancillary components such as screws, wedges, plates and instruments are classified as class 3.
- 8.10 Implantable devices and long-term surgical invasive devices that are implantable devices that come into contact with the spinal column and are not ancillary components such as screws, wedges, plates and instruments are classified as class 3.
- 8.11 All other implantable devices and long-term surgical invasive devices are classified as class 2b.
Conclusion for implantable devices
Unfortunately the MDR classification for invasive devices as a document is not as clear in the classification rules as it could be. Finding the way to inconsistencies (mix of rules with non-invasive devices) and exceptions is tricky and an unnecessary burden. To help you find your way as smart and easy as possible we created a tool. This MDR classification tool automatically evaluates the assessment and also contains checks for contradictions and gap.
The classification of devices under MDR is a complex task. Save yourself time and money using the right tools.
The MDR classification tool is in fact the best way to actually perform the classification process and document your justification. Click here to go directly to the tool.