The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to the applicable classification rules. The document is intended to provide medical device manufacturers and other parties involved with additional clarifications and recommendations to be considered. However, the provisions of the guidance are non-binding, and the document does not introduce new rules and requirements the parties involved should follow. It is explicitly stated that the guidance should not be construed as representing the official position of the European Commission.
Application of Classification Rules
According to the guidance, first of all, the manufacturer responsible for a medical device in question should determine whether the device is actually subject to regulation under the Medical Devices Regulation 2017/745 (MDR). The types of products subject to regulation include medical devices, accessories thereto, as well as parts and components. Under the general rule, the class of the device under the current classification should be determined depending on the intended use of the device. The MDCG additionally emphasizes that the accidental use of the device does not impact its classification. However, in the case for a significant period of time in the course of a normal clinical practice, the intended use of the device has changed, the manufacturer should take this into consideration. In particular, such use should be considered in the context of a conformity assessment the device should be subject to. As it is mentioned in the guidance, in case several rules, or if, within the same classification rule, several sub-rules, apply to the same device based on the device intended purpose, the strictest rule and sub-rule resulting in higher classification will apply.
The MDCG further provides the details regarding the particular way the classification rules should be applied. In particular, according to the document, the manufacturer shall duly consider any and all applicable rules, while the final classification should be determined on the basis of the highest applicable class. When making such a determination, the manufacturer should consider the intended use of the device in question, as well as its specific features that can impact safety and performance. It is important to mention that apart from the aforementioned Regulation, the manufacturer should also consider the provisions of any other applicable acts and regulations, including the guidance documents providing additional clarifications and recommendations. The rule could be applicable even it is general and is not device-specific.
In order to demonstrate the way the classification rules should be applied when determining the class of the device, the document provides an example of a simple wound drainage system that is composed of three elements. Should the system be supplied without any of the elements, such elements should not be considered when determining the class. The example shows that the addition of one element could change the situation significantly and result in assigning the device in a whole to a higher class. Hence, the manufacturer may decide to supply the element with higher class separately, as the conformity procedures to be applied will be different.
The guidance provides the following table describing the example:
The MDCG acknowledges that certain issues may arise when interpreting and applying current classification rules. In particular, it is stated that interpretation issues may arise with regard to some of the medical devices. The document further describes the way such issues could be resolved.
For instance, in case of a dispute regarding the way the device should be classified between the medical device manufacturer and notified body, such a dispute should be finally resolved by the national regulating authority in the sphere of medical devices in the country the manufacturer is based in. In the case of manufacturers based outside the EU, the competent regulating authority should be determined depending on the country where an authorized representative of a foreign manufacturer is based. At the same time, if the notified body involved is based in another Member State, the competent authority should also consult with the respective authority of the Member State where the notified body is based.
Hence, under the general rule:
- The initial classification of a new medical device should be determined by the manufacturer on the basis of existing classification rules;
- A conformity assessment body (notified body) should verify whether the medical device subject to review is classified in a correct way;
- In case of any disputes regarding the classification of a medical device, such disputes should be resolved by a competent national regulating authority determined as described hereinabove.
It is also important to mention that outside this regulatory procedure, competent authorities may refer on an ad hoc and voluntary basis complex classification cases for discussion at the Borderline and Classification Working Group of the MDCG.
Additional Classification Rules
Apart from the specific aspects described hereinabove, the guidance provides additional details regarding the particular classification rules and the way they should be applied. In particular, the document contains flowcharts describing the decision-making process for different types of medical devices. The flowchart outlines the most important criteria to be taken into consideration when determining the class of the device under the existing classification. For instance, in the case of an invasive medical device, the manufacturer shall consider the period during which the device should be used. Other important aspects to be considered include, inter alia, the following ones:
- Whether the device is intended to contact intact skin or wound area;
- Whether the device is intended to administer medicines;
- Whether the device is intended to supply energy or ionizing radiation;
- Whether the device is intended to be used in the context of critical systems of the human body (e.g. central circulatory system or central nervous system).
Special rules should be also applied in the case of dental devices (e.g., implants) or surgical mesh devices.
In summary, the present MDCG guidance provides detailed recommendations and clarifications regarding the applicable classification rules for medical devices, and also on the way the class of a new medical device should be determined. The document also explains the way the disagreements regarding the classification should be settled.
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