Medical Device Classification In The European Union — pepgra.com

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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.


Medical Devices Writing Services

Philosophy of Medical Device Classification

In terms of practice it can’t be economically justified neither is it feasible to form all medical devices undergo every stringent assessment in terms of conformity. A system of control which is graduated should be quite enough. Under the tenets of such a system, the degree of control matches with the degree of possible risks innate within a selected device type. This warrants the necessity for a system for classifying medical devices. This ensures that medical devices are applied through the specified process for evaluating conformity (Wheeler, 2018). With a view to make sure that analysis of conformity as per the ecu Union Medical Device Directives operates in an efficient manner, it’s imperative that manufacturers are during a position to work out the category under which their devices will classified right from the very initial developmental phase of the device. Thus, the necessity was felt to determine a system of rules for device classification as under the Directive. this is able to allow all device manufacturers to classify their own devices.
The system of classification of medical devices is predicated on risk on the idea of susceptibility of the physical body while keeping in mind the potential hazards linked with the device. An approach of such kind facilitates the use of a preset criterion that would be amalgamated in diverse manners with a view to work out classification (Global Legal research facility , 2014). For eg., the period of time during which the device is in touch with a person’s body, the extent of the device’s invasiveness and systemic vs. local effect. Such criterions could then be applied to an in depth array of diverse medical devices and technologies. These are commonly termed because the rules for classification and are outlined within Annex IX of Directive 93/42/EEC. To an outsized degree, it matches to the principles of classification setup by the worldwide 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’s mandatory that they adhere to the acceptable medical device directive or regulation as outlined by the ecu Commission (EU). it’s critically very significant to remember of the acceptable medical device classification for a specific product before placing a ‘CE’ mark on the device. Regulatory requirements are impacted through device classification and also the route for approval along side associated costs (French-Mowat & Burnett, 2012).


Medical Device Classification In The European Union

Medical Device Classification in Europe

The initial step within the regulatory process in Europe would be to work out the directive that’s applicable to a specific product. an outsized number of devices fall into the medical device directive 93/42/EEC, however, there are certain high risk devices like implantable devices that must adhere to the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. At an equivalent 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) №2017/745 (for active implantable devices or medical devices), or the In Vitro Diagnostic Device Regulation (IVDR) №2017/746 would be taken under consideration . A rule based scheme of classification is employed by Europe for medical devices which fall into the ambit of MDD. There are around 18 rules which need to be adhered to and these are often mentioned in Annex IX of the MDD. Though the general structure of the principles from MDD is maintained within the MDR, there’s scope for expanding the principles (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.


The 18 rules are further bifurcated into four groups.

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 possess their individual scheme of classification whereas, active implantable medical devices fall into the scope of comparable requirements as that of sophistication 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’s the responsibility of the device manufacturer to work out the proper class for his or her product. Subsequently, the essential responsibility for device classification rests on the manufacturer. The manufacturer is meant to verify classification with a Notified Body (NB) of their preference. just in case there’s uncertainty or any quite difference of opinion between the manufacturer and therefore the NB, it’s essential to refer the difficulty to a competent authority for arriving at a choice (HPRA, 2009). The HPRA also accepts formal requests on the a 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 concerning the register of sophistication I devices. Formal requests for classification also are 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.
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