Combination studies are clinical trials in which the clinical trial of medicinal products in accordance with the Austrian Medicinal Products Act (AMG) and Regulation (EU) No. 536/2014 (CTR) is conducted together with a clinical investigation of a medical device in accordance with the Austrian Medical Devices Act (MPG) and Regulation (EU) No. 2017/745 (MDR) or a performance study of an in-vitro diagnostic in accordance with Regulation (EU) No. 2017/746 (IVDR).

A typical example is the joint investigation of the efficacy and safety of a medicinal product and the performance evaluation of a companion diagnostic.

These combination studies must be submitted and authorised in parallel in accordance with both the CTR and the MDR or IVDR:

• CTR: Centralised submission via the Clinical Trials Information System (CTIS) with coordinated assessment by the authority and the concerned ethics committee.

• MDR/IVDR: National submission with subsequent assessment by the concerned Ethics Committee, followed by the authority

These parallel processes often lead to delays in the start of trials.

The amendment to the MPG, Federal Law Gazette I No. 102/2024, has stipulated since 28 February 2025 that the ethics committee responsible for combination studies in accordance with the CTR is also responsible for the MPG/MDR/IVDR part.

Relevant legal text (Section 17 para. 5 MPG)

“Bei klinischen Prüfungen, die sowohl den Vorschriften dieses Bundesgesetzes als auch jenen des Arzneimittelgesetzes unterliegen, ist die für die Beurteilung gemäß Arzneimittelgesetz zuständige Ethikkommission auch im Rahmen dieses Bundesgesetzes zuständig. Für multizentrische Studien gilt dies nur, sofern diese Ethikkommission gemäß § 17 Abs. 2 kundgemacht wurde; andernfalls gilt Abs. 4. Das Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz veröffentlicht die zuständigen Ethikkommissionen auf seiner Website.”

The following procedure is recommended to ensure a smooth and speedy process:

1. Submission of the medicinal product part via CTIS in accordance with CTR.

2. The responsible ethics committee is assigned automatically and can be requested the next working day from the Federal Office for Safety in Health Care (BASG) at clinicaltrials@basg.gv.at.

3. Submission of the MPG/MDR/IVDR part after completion of the validation of the CTR dossier in CTIS to the responsible ethics committees with the CTR ethics committee as the evaluating ethics committee (formerly "lead ethics committee"), even if this is not responsible for a trial site. The respective submission deadlines of the ethics committees should be taken into account. However, the clear aim is to assess both parts of the study - medicinal product and medical device/IVD - together wherever possible.

4. A preliminary ethics vote in accordance with the MPG should be available by the time the CTR assessment is completed (between day 26 and day 38 after validation). This can already be used for submission to the Federal Office.

5. After submission to the Federal Office, the regular MDR/IVDR deadlines for validation and assessment apply.

The aim is to treat both parts of the study together.

The Federal Office endeavours to complete both procedures in a coordinated manner so that the CTR and MDR/IVDR authorisations can be granted at the same time.

The stated deadlines are to be understood as official target values. Only the legal requirements of the CTR, MDR and IVDR and the official decisions based on them are authoritative and legally binding.

The information provided to the persons concerned in combination studies must also be designed in such a way that it is clear, concise, complete, relevant and understandable for medical laypersons.

Since in most cases the clinical trial according to the CTR is the main aspect and the clinical trial or performance study according to the MDR or IVDR is complementary, a joint information document is recommended.

If separate documents can achieve better fulfilment of the above-mentioned requirements, this approach is also permissible.