A Q&A document for sponsors of clinical investigations of medical devices under the European Union (EU) Medical Device Regulation (MDR) has been released by the Medical Device Coordination Group (MDCG).
The document begins with a series of general questions, outlining the differences between the EU MDR and the previous directives it replaces along with what is considered to be a clinical investigation under the MDR. Further questions detail the regulatory pathway that a sponsor should follow depending on whether a clinical investigation is done to support the conformity assessment procedure of the investigated device or whether the clinical investigation is being conducted in the pilot stage. A summary of the regulatory pathway determination process is summarised in a flow chart included at the end of the document in Annex I. Other key questions in the first section detail the definition of burdensome/invasive procedures, how sponsors can assess if the planned use of a medical device in the clinical investigation is covered by the intended purpose and what the safety reporting requirements for clinical investigations are.
The next section of the document covers modifications to clinical investigations. A substantial modification of a clinical investigation is defined as “a change to the clinical investigation which is likely to have a substantial impact on the safety or health or rights of the subject or on the robustness or reliability of clinical data generated by the investigation.” A non-exhaustive list of substantial modifications is included at the end of the document in Annex II. The remaining questions in this section outline the timelines and procedures for implementing a substantial modification.
A section on timeline considerations details that whilst the reporting of the study start date is not a requirement of the MDR, it is required by national legislation in some Member States and should be indicated in the EUDAMED database. The end of a clinical investigation is deemed to be the date of the last visit of the last subject unless another point is set out in the clinical investigation plan. Further questions detail the timelines for reporting the end of a clinical investigation and submitting the summary results to Member States.
The content of the clinical investigation report must meet the minimum requirements outlined in the MDR. Sponsors are also encouraged to include the following information in addition to the mandatory minimum; clinical investigation background, outcome measures, clinical investigation conduct, clinical investigation subjects and deviations and amendments.
The final section details the arrangements for the transitional period. The first question in this section outlines how to submit an application for a clinical investigation or fulfil the safety reporting requirements of the MDR during the period in which the MDR applies but EUDAMED is not yet fully functional. The final questions relate to clinical investigations started prior to the application date of the MDR and detail certain provisions (such as serious adverse event reporting) from the new legislation that will apply after the implementation date.
A key takeaway from the guidance document is that the application of the MDR in regards to the clinical investigation of a device varies between Member States. In addition, it is important to properly define the investigation with regards to the CE marking and the use in relation to the intended purpose of a device prior to commencing the clinical investigation.
If you need more guidance on conducting a clinical investigation of a medical device under the MDR, contact Regulis today.