Euro Roundup: MDCG answers questions on running diagnostic performance studies under IVDR

The Medical Device Coordination Group Document (MDCG) has published a question-and-answer document about running performance studies under the In Vitro Diagnostic Regulation (IVDR).

IVDR requires diagnostic developers to run studies to establish or confirm the analytical or clinical performance of their devices. However, the regulation does not specify details about performance studies. MDCG, an expert panel set up to support the harmonized implementation of medtech regulations, has provided additional information to help sponsors in a Q&A.

“As a general rule, analytical performance must always be demonstrated on the basis of analytical performance studies,” MDCG said. “Clinical performance studies must be performed unless due justification is provided for relying on other sources of clinical performance data.”

The document features 54 questions across six categories. After covering general topics, MDCG sets out its position on the requirements to apply for performance studies, additional requirements for certain studies, the application process, timelines, and substantial modifications.

MDCG’s discussion of additional requirements for certain studies covers the rules on companion diagnostics developed to inform the use of medicines. Companies typically need to file an application to run performance studies involving companion diagnostics. The exception is when leftover samples are used, and the results are not used for interventional purposes. In that case, a notification is required.

Leftover samples are defined as “unadulterated remnants of human derived specimens collected as part of routine clinical practice, for research purposes or other purposes not connected to the clinical performance study in question and after all standard or intended analyses have been performed.” The samples would otherwise be discarded because there is no remaining clinical need for them.

Q&A

European Commission pilots approach to approving combined drug-device trials

The European Commission has started a pilot project to test “a new, more efficient way of approving” studies that combine medicine clinical trials and medical device performance evaluations.

European Union regulations have established legal requirements for individual authorization processes of evaluations of medicinal products, medical devices and IVDs. The requirements burden companies that want to run a clinical trial of a medicinal product in parallel with an evaluation of a medical device or IVD. EU countries began working to understand and address the issues in 2023.

The work has spawned a pilot project to assess an all-in-one coordinated procedure. Participants in the pilot will submit a single application for coordinated assessment of both aspects of their studies. The Commission expects the coordinated procedure to streamline the authorization process, reduce the administrative burden for sponsors, and accelerate patient access to innovative treatments.

Officials are aiming to review five applications in the first phase of the pilot but may adjust that figure based on the submissions received and the availability of resources. The phased approach reflects the “complexities involved in reconciling two regulatory frameworks,” the Commission said. Lessons learnt in one phase will inform the next, more complex phase.

To keep things simple at the start, officials have excluded requirements for an extension to the timelines, such as cell and gene therapies, and programs with separate sponsors for the clinical trial and performance study from the first phase of the pilot.

The call for expressions of interest in the pilot closes on 31 August. Sponsors will learn whether they have been accepted into the program by 31 October.

Press Release

EMA seeks feedback on regulating clinical trials of systemic sclerosis treatments

The European Medicines Agency (EMA) has published a draft concept paper about the need for guidance to inform the development of treatments for systemic sclerosis (SSc).

SSc, also known as scleroderma, is a rare connective tissue disorder that can progress rapidly. EMA has approved medicines that treat manifestations of SSc, such as interstitial lung disease, but there are no drugs for the overall indication. There is no scientific guidance from EMA on the clinical investigation of SSc drugs.

“Guidance on how to design development programs to support authorization of medicinal products for both specific features of SSc as well as products aimed at a general SSc indication is needed, also taking into account the regulatory experience with applications for scientific advice and for marketing authorization.” EMA said.

The agency has identified overall study design elements and endpoints selection as Important aspects that need to be addressed. EMA plans to offer advice on the number and type of studies to run, the design and duration of exploratory and confirmatory trials, and assessments of safety and efficacy. Potential efficacy measures include dedicated composite endpoints for SSc patients.

EMA will provide the information in a reflection paper, which it said is “the most appropriate form of guidance at this stage of knowledge and regulatory experience.” The agency is accepting feedback on the draft concept paper until 30 September.

Draft Paper

MDCG shares guidance on making medtech apps available on online platforms

MDCG has shared guidance on the rules app platform providers must comply with when making medical device software available online.

Companies have created apps to drive insulin pumps, diagnose skin cancers and serve a range of other health functions. MDCG said the compliance of the apps with the safety and performance requirements of the Medical Devices Regulations (MDR) is “paramount.” App platform providers must enable software developers to fulfil their requirements, including in relation to the MDR transparency rules.

“If the manufacturer resides in a third country and the app platform provider is EU-based, the app platform provider would assume the role of an importer and is subject to the relevant requirements laid down in Article 13 of the MDR and IVDR,” MDCG said.

The Digital Services Act may also apply to app platforms. MDCG’s guidance outlines the interplay of the legislation and MDR, explaining that more than one law can apply to a product and discussing when the rules apply to app platform providers.

MDCG Guidance

Other News:

EMA has published a Q&A about its Standard for Exchange of Non-clinical Data (SEND) proof-of-concept study. SEND datasets provide an electronic, structured format for submitting non-clinical raw data as part of an application for initial centralized marketing authorization. EMA is running the study to assess the feasibility and advantages of using the datasets. Q&A

MedTech Europe said it “is deeply concerned” about potential EU countermeasures to tariffs imposed by the U.S. The trade group said the draft package “targets a broad range of finished medical devices, in vitro diagnostic medical devices and a variety of essential components used in their manufacture.” MedTech Europe has called for the urgent exemption of medical technologies from tariffs. Press Release

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is requiring stricter adherence to electronic common technical document (eCTD) specifications. MHRA said “historical sequences are required when you include a change to a document in your dossier.” The changes are intended to improve the quality of eCTD submissions. MHRA Notice

EMA has published a guideline on developing allergen products for treating and diagnosing allergies in moderate to low-sized study populations. The guideline, which will take effect on 1 January, offers advice on managing the challenges associated with working on “allergies where a severely limited number of patients is available to study and/or where clinical co-allergies are common.” EMA Guideline

Euro Roundup: MDCG answers questions on running diagnostic performance studies under IVDR

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