By Evangelia Manika Associate LL.B MSc.
Nowadays, it is very common for healthcare professionals and especially for oncologists to use medical devices in order to administer cancer treatments. In particular, medical devices are used in hospitals not only in the fields of radiotherapy and medical imaging, but also in the field of surgical oncology, in which oncologists perform conservative or reconstructive surgery with the assistance of a medical device whenever possible. In order to treat and/or cure a patient as effectively as possible, it is essential to have medical devices that are both safe and certified.
In this context, it is very important for a medical device to be in compliance with the new EU Regulations (MDR & IVDR). These regulations include, among other things, a number of obligations for all economic operators (manufacturers, distributors, importers, authorized representatives). Among these obligations, there is a crucial obligation for manufacturers to conduct a clinical evaluation. According to MDR’s provisions, clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacture. In the context of the clinical evaluation, it is necessary for a number of medical devices to undergo a clinical investigation in order to obtain the CE marking and meet the general requirements of MDR. In this regard, Article 62(1) of the MDR stipulates that the clinical investigations carried out, as part of the clinical evaluation for conformity assessment purposes, shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of Articles 62 to 80 of the MDR. It is the sponsor’s responsibility to determine the correct regulatory pathway (medical devices with CE marked – medical devices not yet CE marked – medical devices not to be CE marked) for their clinical investigation.
In light of the above, a prior clinical trial may be required for a medical device to be legally marketed in the field of oncology. In the context of clinical trials, in addition to the obligations of the manufacturer, there are also obligations on the part of the oncologist to conduct the clinical trial properly and in accordance with the rules of medical ethics (good clinical practice) and legislation. Among other things, oncologists should strictly follow the protocol of a clinical trial and ensure the privacy of the participant. With regard to the protection of the participant’s data, healthcare professionals are responsible for “explaining” and “simplifying” the Informed Consent Form (ICF) to the participant. The ICF is necessary for a patient’s legal participation in a clinical trial and contains all the necessary information, such as information about the disease and the investigational medical product, the participant’s rights and obligations, adverse events, etc.
In conclusion, medical devices are now widely used in the context of oncology and, in order to be safe for patients, they must comply with the provisions of the legislation and meet basic provisions, such as the performance of clinical trials as part of the technical dossier to obtain CE marking. In addition, in the context of clinical trials of medical devices, it is very important that healthcare professionals are well-aware of their responsibilities and comply with the legislation, always with the ultimate aim of ensuring the safety of clinical trial participants. It remains to be seen how the use of artificial intelligence will affect the medical device clinical trial sector in the future, and whether or not oncologists’ obligations will be affected.