The article highlights the key points associated with the substantial changes to performance studies in the context of the new regulatory framework.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to substantial modification of performance study under Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, or the IVDR). The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by the parties responsible for performance studies in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations – it is explicitly stated that the document should not be construed as one representing the official position of the Commission. Moreover, the MDCG reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
Under the general rule, a party responsible for a performance study (a sponsor) should submit an application/notification to the regulating authorities of the country in which the investigation takes place, together with the relevant documentation. The said application should be submitted in electronic format. Furthermore, it is also stated that the sponsor of a performance study is required to notify the Member State(s) in which a performance study is being or is to be conducted if it intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the performance study by means of the same electronic system.
The MDCG also describes the approach to be applied due to the limited availability of the European database on medical devices (EUDAMED) – the latter is being launched gradually with the modules becoming operational one by one. In particular, the Group has developed a set of documents to be used by the study sponsors. These documents are described in detail in the respective guidance document issued earlier by the MDCG. Apart from the said document, the Group has developed a template for “Substantial modification of performance study under Regulation (EU) 2017/746” which is provided in the present guidance.
In order to facilitate the processes and reduce the regulatory burden for the parties responsible for performance studies, the additional documents described in the guidance are designed in a way ensuring they have the same data fields as the respective EUDAMED elements that are currently being developed.
As it was mentioned before, the present MDCG guidance provides a template to be used by study sponsors when submitting a notification on substantial modification to a performance study. At the same time, the Group additionally encourages the sponsors to check with the individual Member State in which the performance study is planned to be conducted for any specific national requirements.
Furthermore, the template described in the guidance is expected to be withdrawn, once the respective EUDAMED module (the one related to performance studies) will be fully operational.
According to the notification form template provided in the guidance, the information to be submitted by the party responsible for a performance study conducted or intended to be conducted in one of the EU Member States should include, inter alia, the following details:
- ID of the performance study in question;
- Indication of whether the modification subject to review is related to a performance study that is currently suspended/stopped;
- Information about the number of study participants (subjects) involved within the EU and worldwide respectively (as well as in the particular country where the application for a substantial modification is being submitted);
- Indication of a particular EU Member State where the performance study in question currently takes place;
- Short rationale behind the substantial modification subject to review;
- Indication of a specific sphere impacted by the modification e.g., rights of subjects, safety of subjects, health of subjects, or other (it could also be the case that there is no impact on the subjects;
- Indication on whether the substantial modification proposed is expected to impact the clinical data generated, e.g. its robustness or reliability.
The authority additionally emphasizes that the accompanying documentation should be properly named to ensure correct identification.
The notification form also contains a statement whereby the sponsors certifies that:
- The information and documentation submitted with … substantial modification is correct in detail and all the information requested has been supplied;
- The device for performance complies with the applicable general safety and performance requirements, apart from those covered by the performance study and that every precaution has been taken to protect the health and safety of the patient and/or use;
- All the performance study information collected for … notification has been done in compliance with the European data protection legislation (GDRP).
In summary, the present MDCG guidance describes in detail the approach to be applied by a performance study sponsor when notifying the respective regulating authorities of substantial modification to an ongoing investigation. The document outlines the scope of information to be included in such a notification and also highlights the most important aspects to be considered with respect to the format and content in general.
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