What changes in the classification of medical devices with the new EU Reg. 2017/745 (MDR)?

One of the first activities that the manufacturer has to carry out is to decide whether, in the light of the new MDR, a product falls within the definition of a medical device and, if so, whether the risk class of the medical device has changed.

Definition of medical device

The MDR does not substantially modify the current definition of medical device contained in the MDD (Medical Devices Directive) and AIMDD (Active Implantable Medical Devices Directive). However, taking into account that the two directives have been merged into a single regulation, the current art. 2 lett. 1) presents a broader formulation, which is in line with the definition contained in the In Vitro Diagnostic Regulation (IVDR). In fact, the standard includes concepts as "implant", "reagent", "forecast", "prognosis".

The same article also clarifies that products specifically intended for the cleaning, disinfecting or sterilizing of medical devices are considered medical devices as well.

Scope expansion

The MDR will have a much wider scope of application than the MDD, and will apply also to many products that are not currently classified as medical devices.

More precisely, the MDR will apply to:

• a series of products listed in Annex XVI, which are included in the MDR for safety reasons, even if they do not have the same medical use (art, 1 paragraph 2, 3, 4, 5). This Annex includes aesthetic products or other implantable or invasive products such as non-corrective contact lenses, equipment used for liposuction or laser products for hair removal. The European Commission will have the power to add new product groups to Annex XVI through delegated acts (Article 115 MDR). 
• devices using non-vital human cells or tissues that support the action of medical device (Article 1 paragraph 10)

Moreover, the MDR better defines what is meant by nanomaterial (art, 2 Rule 18) and regulates the risk class of the devices that incorporate nanomaterials in greater detail (Annex VIII, Rule 19). This is a significant change, since such products do not fall within the MMD at the moment. 

Reclassification of products that have already been classified as medical devices

The MDR maintains the division of medical devices into four risk classes (Class I, IIa, IIb and III). The rules for defining the risk classes are contained in Annex VIII.

However, some of the rules contained in Annex VIII have changed significantly, thus leading to a possible re-classification of some devices (mostly in higher risk classes). For example, spinal cord replacement implants or implantable devices that come into contact with the spinal column (except for screws, wedges, plates and tools) will all be classified in Class III (Rule 6). Similarly, all active implantable devices and their accessories will be considered Class III (Rule 8) while today they may be in lower classes.

Rule 21 also raises the risk level of all devices that are composed of substances or combinations of substances intended to be introduced into the human body through a body orifice or to be applied on the skin; they will no longer be included in class I (as they are now), but will always fall within one of the higher risk classes.

Furthermore, it is likely that the new Rule 11 will heavily affect the classification of software. In fact, most of the software is now in Class I, while Rule 11 envisages much more stricter requirements, which will probably cause lots of software to be included in higher risk classes. This will imply the involvement of the Notified Body and the application of different conformity assessment procedures, which will represent a greater burden for software producers in terms of budget and time planning.

This will have a strong impact on the field of medical applications.

Review of the mechanisms for determining borderline products

The mechanism of analysis of the so-called borderline products will undergo a radical change.

At present the situation is as follows:

• According to Recital 13 of Directive 2007/47 EEC (which envisages the establishment of a decision-making procedure between Member States to determine whether or not a product falls within the definition of medical device), a working group has been set up at the EU Commission called Borderline and Classification Medical Devices Expert Group to discuss controversial cases: this Group publishes a manual with the (non-binding) decisions taken. The last one is the Manual on borderline and classification in the community regulatory framework for medical devices (version 1.18 - 12-2017)
• Article 13 (1) (d) of the MDD Directive then establishes that the EU Commission, when seised by a Member State, can decide whether or not a specific product falls within the definition of ‘medical device’. The first (and only) decision on the basis of this rule was the Decision of August 2017 on the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry (Vaccinium macrocarpon), is to prevent or treat cystitis.

Instead, Article 4 of the MDR, entitled Regulatory status of products, introduces a much stronger legal mechanism: it establishes that the European Commission can act not only on input from a Member State, but also autonomously (Article 4 paragraph 2), while always remaining subject to the opinion of the Medical Device Coordination Group (MDCG - Article 103): this is to ensure a more consistent classification of borderline products in the EU.

It is noted that some of the positions taken in the Manual of borderline devices could change, due to the potential reclassification introduced by the MDR, which not only slightly broadens the definition of medical device (for example, including the "forecast" and "prognosis" of a disease as envisaged functions), but also qualifies certain aesthetic products as medical devices (Annex XVI).