MDCG 2021-6 Rev. 1 is available: HERE
Examples of newly added Q&As are provided below, along with short extracts of the answer.
Please refer to the MDCG document for the complete list of new & revised Q&As, and to read the full answers to each question.
Is there legislation other than the MDR that needs to be considered when conducting clinical investigations as defined by the MDR?
“The MDR allows, and for some aspects requires, Member States to have national legislation in place…consult the websites of national competent authorities and ethics committees.
Further, in addition to the MDR there is other European Union legislation that may be applicable, depending on whether other products than devices are being studied in the same clinical study , such as the EU Regulation 536/2014 (CTR)…”
Complying with the MDR does not remove the obligation of sponsors to comply with other relevant legislation, issued by the European Union or Member States, which is not specifically mentioned above.”
Are all clinical studies that involve use of devices considered clinical investigations as defined by the MDR?
“No, there are situations when devices are used in clinical research but where the scope is not to make a systematic investigation involving one or more human subjects, to assess the safety or performance of the device(s) used. For example, a clinical trial of a medicinal product may involve determining blood pressure or oxygen saturation. This will require the use of devices but since the safety or performance of the devices used for blood pressure/oxygen saturation are not being assessed, such studies would not be considered clinical investigations and devices used in these studies are not investigational devices as defined by the MDR.
Note that in these situations, the devices in question will have to be placed on the market or put into service in a manner which is compliant with the MDR. Other national and EU legislation regarding aspects such as clinical research, ethical review and personal data protection may also be applicable.”
According to the MDR, are usability tests considered clinical investigations?
“Manufacturers should document the usability of a medical device, and various types of usability test may be conducted for this purpose. Depending on the overall test design, usability testing may or may not fall under the definition of clinical investigation in Article 2(45) of the MDR…
Factors to be considered when determining whether a usability test is also a clinical investigation should include the scope and purpose of testing, as well as how the human subjects are exposed to the device. Note that prototypes or parts of a future device may have a medical purpose which is evaluated in the usability test and they would thus be considered as investigational devices, whereby the test could be a clinical investigation, in particular when the usability test involves exposing users to risk related to the device or where poor usability may lead to patient or user safety risks.”
When will EUDAMED allow applications for clinical investigations?
“The use of EUDAMED for Clinical Investigation and Performance Studies becomes mandatory at the end of the 6 months transitional period after the publication of a notice in the Official Journal of the European Union that EUDAMED has achieved full functionality following the outcome of an independent audit. It will not be possible to submit applications via EUDAMED before it is mandatory to use.”
What is the role and responsibility of the sponsor’s legal representative?
“Where the sponsor of a clinical investigation is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative. Such legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this regulation and shall be the addressee for all communications with the sponsor provided for in this Regulation.
Per the Regulation, the legal representative is responsible for ensuring compliance with the sponsor’s obligations pursuant to the MDR…It is acknowledged that responsibilities and tasks contracted to the legal representative may expand beyond the legal requirements of the MDR, which is a business decision between the parties. In situations where the legal representative also functions as a CRO, it is recommended that the agreement between the sponsor and the CRO clearly defines what responsibilities are assigned in terms of the legal representative capacity and what tasks are assigned to the CRO capacity.”
Annex III is newly added: “Does my combination product study require an MDR clinical investigation submission?”