The conduct of Clinical investigations, or Clinical trials involving investigational devices, is another area in which the new European Union Medical Device Regulation (EU MDR) brings current Medical Device Directive (MDD) up to date. Not only up to date with the European Authorities current expectations for the conduct of clinical investigations, but also brings the European Union requirements into line with the requirements for clinical trials involving investigational devices elsewhere in the world.
The MDD’s sole article on the subject, Article 15 “Clinical investigation” is replaced by twenty articles in new EU MDR, Articles 62 through 82. This global alignment extends to both the requirements and the terminology. For example, the requirements in the new EU MDR are addressed to the “Sponsor”, not the “Manufacturer” as is currently the case in MDD. While the MDD’s current requirement to “notify” the Health Authorities of an intention to perform a clinical investigation, is being replaced with the requirement to submit an application to conduct a clinical investigation. However, for lower risk devices the sponsor can still proceed to start the investigation if the application is not refused. Meaning that in practice, at least for developers of lower risk devices, the new application procedure is unlikely to result in any new delays to starting clinical investigations in the EU.
The new EU MDR Articles 62 through 82 address all the familiar topics related to clinical investigations; the need for informed consent, considerations for vulnerable populations, the application process, requirements for the conduct of the investigation, Adverse Event reporting etc. But while the majority of the requirements are new for clinical investigations conducted in the European Union, sponsors conducting investigations in other regions will find no surprises in these new Articles.
While the new Articles 62 through 82 describe “what” is required, they must be read in conjunction with the more detailed “how” to do of the new Annex on “Clinical investigations”, Annex XV. The new Annex XV updates and extends part 2. of the current MDD’s Annex X “Clinical evaluation”. This new and expanded Annex XV specifies the information to be considered in; (a) the Clinical Investigation Application form, (b) the Investigator’s Brochure, (c) the Clinical Investigation Plan, (d) Sponsors obligations and (e) the Clinical Investigation Report. However, the new MDR’s Annex XV is still far less specific than either ISO14155 or ICH GCP. It therefore appears to be setting only the minimum requirements for conducting clinical investigations in the EU. Meaning that sponsors should still anticipate that the Authorities will judge their applications by the higher standards of ISO14155 or ICH GCP.