EU MDR Risk Classification: Guide and Case Study

Manufacturers are responsible for determining the appropriate EU MDR risk classification for devices within their portfolio. Several types of medical devices have been up-classified when transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). The MDR introduced four additional rules, to bring the total number of rules to 22, to help enforce a more conservative approach to classification by considering long-term use, safety, efficacy, invasiveness, pharmacological effect, software as a medical device, etc. Additionally, proper classification is important to determine the conformity assessment route for approval in Europe. The classification impacts labeling, IFU, Post Market Surveillance (PMS), and Clinical Evaluation Report (CER) requirements among other things. For example, manufacturers of Class III devices need to update their PMS and CER documentation on an annual basis and draw up a Summary of Safety and Clinical Performance (SSCP). In addition to covering the standard medical devices under the definitions from Article 2 and Chapter I of Annex VIII, the EU MDR provides a list of six product types that may not have a medical purpose but still come under the MDR regulation via Annex XVI (ex. Contact lens, liposuction equipment, etc.).  

A common question posed by manufacturers of procedure packs and systems or devices with accessories is how their devices would be classified and applied to their products. For medical devices that can be used in combination with other medical devices, each medical device must have its own classification. This also applies to accessories that have an intended medical purpose. Should a combination of medical devices be packed together then it would typically come under a procedure pack or system. 

Considerations and guidelines for determining EU MDR risk classification

Within this article, we provide considerations and guidelines for navigating EU MDR risk classification for medical devices including answering the following questions:

• • D.I.E.M? 
  • Which of the 22 Rules in Annex VIII apply to a medical device?

D.I.E.M?

Based on the Intended Use and Mechanism of the medical device, via the definitions listed in Article 2 and Chapter I of Annex VIII in the MDR, it would be useful for manufacturers to determine their devices’ D.I.E.M: 

D: Duration

I: Invasiveness

E: Energy Source

M: Measurable

Duration

Duration helps manufacturers classify based on how long their medical device is used in treatment without interruption as ‘transient’, ‘short term’, or ‘long term’. For example, surgical instruments can be used throughout a long 8-hour procedure, though the duration is considered transient since their continuous usage is perhaps a few seconds or minutes each time. 

Invasiveness

A medical device can be determined by the manufacturer based on (1) how much of the medical device enters the human body and (2) how long it stays inside the human body after the procedure. These two factors help classify the device as implantable or otherwise. Typically, devices that are implantable attract a more stringent conformity assessment. Medical devices which are placed within the human body for over 30 days are easily classified as Invasive – however, manufacturers of partially implantable medical devices, need to take greater care to properly understand the inference of the 22 Rules and determine whether the device is implantable or not.

For example, catheters used to provide temporary vascular access and removed from the patient in 7-10 days are considered not implantable while bio-absorbable sutures may be considered implantable within the guidelines of the EU MDR.

Energy Source

If an external energy source is required to operate the medical device, manufacturers must consider their device as ‘Active’. Interestingly software is considered an active device and hence cannot be reviewed only in the context of Rule 11 (an updated rule introduced into the MDR to formally classify software).

Measurable

Manufacturers making medical devices that are used for any kind of quantification (including syringes or spoons used to quantify the amount of medical product delivered), must define their devices as measurable.

Which of the 22 Classification Rules in Annex VIII apply to a medical device?

Once manufacturers have a clear understanding of the D.I.E.M of their medical devices, it becomes easier to go through the 22 Classification Rules as set out in Annex VIII of the MDR and select the most appropriate Rule to apply. In cases where several rules apply to the same device, the manufacturer has to select the strictest rule and sub-rule to place the device in the highest risk category. 

Case study: EU MDR risk classification route for a standard adhesive tape

In the table below, we share an example analysis for the classification of a generalized adhesive tape device, to illustrate the expected approach. It is important to first qualify the product as a medical device with an appropriate rationale. 

Rationale for the qualification of the product as a medical device 

Adhesive tapes designed for specified continuous glucose monitors (CGMs) and insulin pumps are considered a medical device due to their intended purpose of securely attaching the CGM or insulin pump to the body. Since these tapes have direct contact with the surface of the body of the patient, they fall under the definition of a non-invasive medical device according to the MDCG Guidance on classification of medical devices (i.e. MDCG 2021-24, October 2021). Adhesive tapes designed for specified continuous glucose monitors (CGMs) and insulin pumps are considered a medical device due to their intended purpose of securely attaching the CGM or insulin pump to the body. Since these tapes have direct contact with the surface of the body of the patient, they fall under the definition of a non-invasive medical device according to the MDCG Guidance on classification of medical devices (i.e. MDCG 2021-24, October 2021). 

Applying the 22 Classification Rules in Annex VIII for standard adhesive tape

Prepare for your MDR transition

While the EU Commission has extended the transition period for the majority of medical devices under the MDR, it is still important that manufacturers begin their preparations for transition, especially with determining the classification of their products, as that impacts the duration of the transition period. The availability of Notified Body resources and constraints on these resources are expected to remain for some time. Medical device manufacturers that choose to leave their transition to the last minute may be in a situation where they are unable to obtain CE certification for their devices. Subsequently, they’ll be unable to place devices on the market. Device classification is one of the first steps in this transition. 

Learn more about the EU MDR risk classification with MedEnvoy 

This article briefly touches on some of the considerations for manufacturers when deciding what MDR risk classification their device fits under the EU MDR. Contact MedEnvoy today to ensure your device meets clinical evaluation performance standards under the MDR. MedEnvoy also provides consulting services, learn more about our subject matter experts by clicking here. 

Related articles:

• • Annex II Under the MDR: What is a Technical File?
  • Medical Device Risk Management: Hazards and Controls