Software under the medical devices regulations

The Guidance (MDCG 2019-11) provides for a wealth of new interpretative principles to qualify software products and classify them in accordance with the new EU Regulations.

What is the scope of the new guidelines?

The document MDCG 2019-11 is primarily addressed to manufacturers of software products falling in scope of the MDR and IVDR. However, all economic operators having software-driven products in their medical devices portfolio should be mindful of the new principles.

Unlike the current MEDDEV 2.1/6 (July 2016), which focuses essentially on standalone software, the new guidelines broadly apply to "Medical Device Software", defined as software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a "medical device" in the MDR or IVDR, “regardless of whether the software is independent or driving or influencing the use of a device”.

Are the former decision trees for software qualification still valid?

It is expected that MDCG 2019-11 will replace the current MEDDEV 2.1/6 (and existing decision trees) with regard to software products qualified under the MDR, from 26 May 2020, and IVDR, from 26 May 2022. Although partly based on the current MEDDEV 2.1/6 (notably, with regard to the examples provided in Annex II and existing concepts), the logic behind the new guidelines is fully MDR- and IVDR-based and requires new software qualification strategies.

For MDR products, the new decision tree clarifies from the outset that any software which is (i) an Annex XVI medical device, (ii) an accessory for a medical device, or (iii) a software driving or influencing the use of a medical device, shall be covered by the MDR although it doesn’t achieve a medical purpose on its own. The new decision tree further addresses software products falling under the definition of a "medical device" / "in vitro diagnostic medical device".

Under the IVDR, manufacturers should consider whether the intended purpose is “substantially driven by data sources” coming from an IVD medical device (IVDR) or a medical device (MDR). In case of doubt (for instance, because the intended purpose appears to fulfil both the MDR and IVDR definitions), manufacturers are encouraged to weight data sources based on the significance of the information “in relation to fulfilling the intended purpose” to determine which Regulation applies.

When is a software “driving or influencing the use” of a (hardware) medical device?

Software that is driving or influencing the use of a (hardware) medical device is covered by the Regulations either as "part or component" of a device or as an "accessory" for a medical device.

The definition of this concept is three-fold:

• The software does not have or perform a medical purpose on its own.
• The software does not create information on its own for one or more of the medical purposes described in the definition of a "medical device" or an "in vitro diagnostic medical device".
• It can, but is not limited to:
  • operate, modify the state of, or control the device either through an interface (e.g., software, hardware) or via the operator of this device; or
  • supply output related to the (hardware) functioning of that device.

How should software manufacturers apply classification rules?

The MDCG 2019-11 clarifies that Rule 11 of the MDR is not the only rule which manufacturers should be considering to qualify their Medical Device Software. It further provides that a Medical Device Software that both (i) achieves its own intended purpose and (ii) drives or influences the use of a (hardware) device for a medical purpose, is classified on its own based on the intended purpose achieved.

The MDCG also considers sub-rule 11(b) (for Medical Device Software intended to monitor physiological processes or parameters) as a specific rule for Medical Device Software intended “only” for monitoring purposes, considering that in most cases such software provides information governed by sub-rule 11(a) (Medical Device Software providing information which is used to take decisions with diagnostic or therapeutic purposes).

With regard to the IVDR, the MDCG 2019-11 provides limited additional guidance. Examples of software which may fall in scope of the IVDR are included in Section 5 and Annex II of the new guidelines.

Is placing on the market relevant for Medical Device Software qualification or classification?

Yes. Unlike the current MEDDEV 2.1/6, the MDCG 2019-11 adds "placing on the market" and "putting into service" to the equation by drawing a difference between medical devices placed on the market in their own right versus those embedded as an integral part or component of a (hardware) medical device, with consequences for conformity assessment decisions. The guidelines further warn manufacturers in case of changes to an existing Medical Device Software, as such changes may lead to (re-)qualification and (re-)classification, impacting route-to-market strategies.

What about claims?

Manufacturers must ensure that all regulatory requirements for placing on the market and conformity assessment have been fulfilled. This includes compliance with Article 7 (of the MDR and IVDR) which, according to the MDCG, “entails that any claims, relating to the intended medical purpose of their [Medical Device Software] are supported by clinical evidence”. Importantly, Article 7 does not solely apply to product information listed in Annex I to the Regulations, but extends to the advertising of medical devices and any making available or putting into service of a medical device on the Union market.

What’s next?

The MDCG 2019-11 refers to the following upcoming MDR / IVDR guidance, which may be of interest for manufacturers:

• Further horizontal guidance concerning the concepts of “serious deterioration of a person’s state of health” and “surgical intervention” (Rule 11 of the MDR);
• Further horizontal guidance on the application of (non-software-specific) qualification, classification and implementing rules under the MDR and IVDR;
• The transposition of the “Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices” (Manual) under the MDR and IVDR.

In light of technological progress, the MDCG announced that further examples will be regularly published in both the Manual and in the MDCG 2019-11.