Medical Device Classification In The European Union

In Brief

• Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all medical devices to stringent conformity assessments.
• Moreover, the onus of classifying a medical device is the responsibility of the medical device manufacturer. The device manufacturer has to be aware about the class under which their device will fall under, right from the time the device is in the process of development.

Philosophy of Medical Device Classification

In terms of practice it cannot be economically justified nor is it feasible to make all medical devices go through every stringent assessment in terms of conformity. A system of control which is graduated should be more than enough. Under the tenets of such a system, the degree of control matches with the degree of possible risks innate within a specific device type. This warrants the need for a system for classifying medical devices. This ensures that medical devices are applied through the required process for evaluating conformity (Wheeler, 2018). With a view to ensure that evaluation of conformity as per the European Union Medical Device Directives operates in an effective manner, it is imperative that manufacturers are in a position to determine the category under which their devices will classified right from the very initial developmental phase of the device. Thus, the need was felt to establish a system of rules for device classification as under the Directive. This would allow all device manufacturers to classify their own devices.

The system of classification of medical devices is based on risk on the basis of susceptibility of the human body while keeping in mind the potential hazards linked with the device. An approach of such kind facilitates the utilization of a preset criterion that could be amalgamated in diverse manners with a view to determine classification (Global Legal Research Center, 2014). For eg., the time period during which the device is in contact with a human body, the level of the device’s invasiveness and systemic vs. local effect. Such criterions could then be applied to an extensive array of diverse medical devices and technologies. These are commonly termed as the rules for classification and have been outlined within Annex IX of Directive 93/42/EEC. To a large degree, it matches to the rules of classification setup by the Global Harmonization Task Force (GHTF) within the guidance document GHTF/SG1/N15:20063.

Prior to a medical device being legally classified by manufacturers as ‘CE’ within Europe, it is mandatory that they adhere to the appropriate medical device directive or regulation as outlined by the European Commission (EU). It is critically very significant to be aware of the appropriate medical device classification for a particular product prior to placing a ‘CE’ mark on the device. Regulatory requirements are impacted through device classification and also the route for approval along with associated costs (French-Mowat & Burnett, 2012).

Medical Device Classification in Europe

The initial step within the regulatory process in Europe would be to determine the directive that is applicable to a particular product. A large number of devices fall under the medical device directive 93/42/EEC, however, there are certain high risk devices such as implantable devices that needs to adhere to the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. At the same time, the In Vitro Diagnostic Directive (IVDD) 98/79/EC is applicable to In Vitro Devices (IVDs) (HPRA, 2009). In case, a manufacturer opts to project adherence to regulation, the Medical Device Regulation (MDR) No. 2017/745 (for active implantable devices or medical devices), or the In Vitro Diagnostic Device Regulation (IVDR) No.2017/746 would be taken into account. A rule based scheme of classification is utilized by Europe for medical devices which fall under the ambit of MDD. There are around 18 rules which have to be adhered to and these can be referred to in Annex IX of the MDD. Though the overall structure of the rules from MDD is maintained in the MDR, there is scope for expanding the rules (McDonough, 2019).

Segmentation of Medical Devices within Europe

On the whole, every medical devices can be segmented into four key categories. These would include;

• Non-invasive medical devices
• Invasive medical devices
• Active medical devices
• Special Rules (comprising of disinfectant, contraceptive and radiological diagnostic medical devices) or devices comprising of animal tissue or drug-device combination.

The above said 18 rules as specified within Annex IX of the Directive and pertinent regulation lay down the fundamental principles for classification. As per MEDDEV 2.4/1 Rev.8, such rules are additionally elucidated with descriptive samples. The 18 rules are further bifurcated into four groups.

Rules	Device
Rules 1-4	Non-Invasive Devices
Rules 5-8	Invasive Devices
Rules 9-12	Active Devices
Rules 13-18	Special rules e.g. devices containing tissue of animal origin, due-device combinations

Furthermore, the MDR has also framed certain special rules that also cover Nano-materials (Donnell, 2016). Medical devices are further segmented as per the classes as mentioned below. IVDs are known to have their individual scheme of classification whereas, active implantable medical devices fall under the scope of similar requirements as that of class III devices (the MDR also includes active implantable medical devices).

• Class I – Provided non-sterile or devices that are devoid of a measuring feature (low risk)
• Class I – Provided sterile and / or is inclusive of a measuring feature (low/medium risk); to this group reusable surgical instruments as Class I reusable surgical instruments have been added by the MDR.
• Class IIa – (medium risk)
• Class IIb – (medium or high risk)
• Class III – (high risk)

When to apply the Health Products Regulatory Authority (HPRA) for Determining Classification

As mentioned above, it is the responsibility of the device manufacturer to determine the right class for their product. Subsequently, the basic responsibility for device classification rests on the manufacturer. The manufacturer is supposed to confirm classification with a Notified Body (NB) of their preference. In case there is uncertainty or any kind of difference of opinion between the manufacturer and the NB, it is essential to refer the issue to a competent authority for arriving at a decision (HPRA, 2009). The HPRA also accepts formal requests on the part of the manufacturer for classifying a medical device, drug-device combination and borderline product before submitting an application for CE marking to a NB or before notification pertaining to the register of Class I devices. Formal requests for classification are also accepted by the HPRA from other interested parties or individuals. All interested parties can download the relevant form ADV-F0006 for medical device classification, from ‘publications and forms’ section of the HPRA website.

References

1. Donnell, M.O. (2016). Nanomaterials and medical device regulations Nanomaterials. [Online]. Available from: https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/webinars/bsi-md-nanomaterials-presentation-30-nov-2016.pdf.


2. French-Mowat, E. & Burnett, J. (2012). How are medical devices regulated in the European Union? Journal of the Royal Society of Medicine. [Online]. 105 (1_suppl). pp. 22–28. Available from: http://journals.sagepub.com/doi/10.1258/jrsm.2012.120036.


3. Global Legal Research Center (2014). Approval of Medical Devices. [Online]. 6462 (September). pp. 23. Available from: www.law.gov.


4. HPRA (2009). Guide to Classification of a Medical Device. Health Products Regulatory Authority. [Online]. 1 (1). pp. 3–11. Available from: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/adv-g0004-guide-to-classification-of-a-medical-device-v2.pdf?sfvrsn=10.


5. McDonough, C. (2019). Medical devices regulation countdown. [Online]. 2019. Available from: http://www.pharmatimes.com/web_exclusives/medical_devices_regulation_countdown_1277912.


6. Wheeler, M. (2018). Classification Of Medical Devices Under The Eu Mdr. [Online]. 2018. Available from: https://emmainternational.com/classification-of-medical-devices-under-the-eu-mdr/.