The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the applicable classification rules. At the same time, the MDCG emphasizes that the document contains non-binding clarifications and should not be construed as an official EC document.
According to the guidance, the classification of medical devices is based on the risks associated with devices used for their intended purpose. In order to determine the particular class a medical device in question should be assigned to, a set of specific criteria should be applied. These criteria include the following: duration of contact with the body, degree of invasiveness, local vs. systematic effect, potential toxicity, the part of the body affected by the use of the device, and if the device depends on a source of energy. These criteria are universal enough to be applied with regard to various medical devices based on various technologies. The particular way the determination of a class should be performed is prescribed by the classification rules set forth in Annex VIII of the Medical Devices Regulation 2017/745 (MDR).
The document further demonstrates how the classification of a medical device corresponds to the regulatory requirements with which it should comply. However, the MDCG emphasizes that the clarifications provided in the guidance are to a certain extent simplified and should not be construed as exhaustive ones. Hence, interested parties should refer to the Regulation itself, as well as to the relevant device-specific guidance documents.
Basics of Classification
Under the general rule, any and all medical devices should comply with the applicable regulatory requirements set forth by the MDR. At the same time, the particular scope of requirements to be applied depends significantly on the class of the device under the risk-based classification.
In particular, the medical devices intended to be marketed in the EU should:
- Meet the general safety and performance requirements, including the requirements regarding the information to be supplied by the manufacturer (Annex I of the MDR);
- Be subject to the reporting requirements under the medical device vigilance system;
- Be CE marked (except custom-made devices and devices intended for clinical investigation, in which case they should comply with the provisions of respectively Art. 52.8 and Annex XIII or Articles 62 – 80, 82 and Annex XV);
- Be assigned a Unique Device Identifier (UDI) number and be registered in the electronic system, in accordance with MDR Article 29;
- If the device is implantable, be supplied with an implant card and information to the patient in accordance with Article 18.
Existing risk-based classification divides medical devices into four classes: I, IIa, IIb, and III, respectively. As mentioned, the particular class the device should be assigned to would be determined depending on the device’s intended purpose, as well as the risks associated thereto. Moreover, there is an additional classification for Class I medical devices to be applied for those that are supplied sterile, have measuring functions, or could be reused.
Initially, the class of a new medical device should be determined by a medical device manufacturer and indicated in the technical documentation associated thereto. In this documentation, a manufacturer should provide clarifications regarding the grounds for the classification.
Another important concept the document refers to is a conformity assessment which stands for the process demonstrating whether the requirements of the MDR relating to a device have been fulfilled. The guidance states that the medical device manufacturer should be the party responsible for demonstrating compliance with the applicable regulatory requirements. In certain cases, a duly designated notified body should be involved in order to carry out a conformity assessment. The MDCG further emphasizes that for medical devices of the higher class under the risk-based classification, additional requirements could be applied. At the same time, some of the requirements are general and should be applied for any and all medical devices intended to be marketed in the EU. These requirements are set forth by:
- Annex I (general safety and performance requirements);
- Annex II (technical documentation); and
- Annex III (technical documentation on post-market surveillance).
As mentioned, the scope of conformity assessment a medical device should be subject to will depend on its class. In certain cases, several pathways are available, and the manufacturer may decide on the one to be followed.
The MDCG explicitly states that there are specific requirements to be applied for custom-made or investigational medical devices irrespectively of the class to which they are assigned.
Clinical Evaluation and Post-Market Surveillance
Apart from the general principles described above, the guidance also covers specific aspects associated with clinical evaluation. According to the existing regulatory requirements, the applicability of clinical investigation depends on the class of the device and its intended purpose – for instance, it is mandatory for implantable and Class III medical devices. Should the manufacturer decide to demonstrate conformity without collecting additional data by virtue of clinical trials, such a decision should be duly justified.
The MDCG further states that for Class III implantable devices and Class IIb active devices intended to administer or remove a medicinal product, the notified body must also follow the clinical evaluation consultation procedure where certain documentation, including the clinical evaluation report, is submitted for review by expert panels as per MDR Article 54 and Section 5.1 of Annex IX. Additional requirements should also be applied in the case of implantable devices and Class II devices.
With regard to post-market surveillance, the guidance states that it is the responsibility of the medical device manufacturer to supplement the clinical evaluation with the additional information collected in the course of activities related to post-market surveillance. As in other cases, the reporting requirements would also be different depending on the class of the device. In particular, the following approach should be applied:
- In the case of Class I medical devices, it would be sufficient for the manufacturer to prepare a post-market surveillance report to be provided to the regulating authority once requested; the In case of medical devices assigned to higher classes, the appropriate reports should be submitted to the regulating authority on the annual or bi-annual basis (depending on the class of a medical device in question).
Moreover, in order to ensure traceability of Class III medical devices, the parties involved in operations with such devices should duly keep the records containing information on UDIs of the devices placed on the market.
In summary, the present MDCG guidance provides a brief overview of the classification of medical devices and applicable regulatory framework. The document outlines the most important differences in the approach to medical devices depending on their class, including the ones related to the scope of information to be submitted by the party applying for the marketing approval.
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