Wien, 17.01.2024 – Text: Catarina Carrão
The European database on medical devices (EUDAMED) is an information technologysystem being built and implemented by the European Commission (EC) to fulfil many of the obligations of the Medical Device Regulation (MDR EU 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR EU 2017/746). It serves a fundamental element in both regulations, aiming to offer a dynamic picture of the lifecycle of medical devices (MDs) and in vitro diagnostic devices (IVDs) on the Union market.
For both the general public and healthcare professionals, specific information will be publicly available via the EUDAMED site, contributing to an increased transparency within the regulatory system. Furthermore, the scheme is intended to avoid multiple reporting requirements within individual Member States, facilitating the flow of information between economic operators, sponsors, Notified Bodies (NBs), and Member States; as well as between Member States and the EC.
EUDAMED is envisioned to integrate six separate and distinct electronic systems (or modules), that assemble, and process information related to (i) Actor Registration (ACT), (ii) Unique Device Identification (UDI) & Device Registration, (iii) NBs & Certificates, (iv) Clinical Investigations (CI) / Performance Studies (PS), (v) Vigilance / Post-market surveillance (PMS), and (vi) Market surveillance.
Which modules are ready, and which ones will come next?
Currently the first three modules (i.e., pre-market modules) are operational and available for voluntary use. The last three (i.e., intersecting, and post-market modules) are expected to be made available for mandatory use in the 4th quartal of 2024 – i.e., six months after an independent audit to the system and publication in the Official Journal of the European Union (OJEU).
What is already known about the Clinical Investigations (CI) / Performance Studies (PS) module?
To use the CI/PS module, a sponsor must initially complete registration in the ACT module of EUDAMED, which will be open for four types of sponsors: Company, Individual, Institution, and Organization. If the sponsor it not established in the Union, then a legal representative needs to be established, which will be responsible for all MDR/IVDR communications and sponsor obligations.
Once the sponsor is registered in EUDAMED, they can submit a clinical investigation (MDR) or performance study (IVDR) application to the Member States where the CI/PS will be conducted. The following documentation needs to be completed/submitted for approval: CI/PS application, Clinical Investigation Plan (CIP-MDR) or Clinical Performance Study Plan (CPSP – IVDR), Investigator’s Brochure, and other documentation according to Annex XV Chapter II (MDR) or Annex XIV Chapter I (IVDR).
Once the CI/PS is successfully validated, EUDAMED generates a union Single Identification Number (SIN) for the CI/PS that will be from then on used in all related documentation/communications regarding the CI/PS. If the CI/PS is to be conducted in more than one Member State, then a Coordinated Assessment Procedure will be made and become available via EUDAMED.
SAEs and Vigilance
All Serious Adverse Events (SAEs) related to the procedure, study device, comparators or device deficiencies that might have led to a SAE in a CI/PS must be reported without delay. Importantly, if such SAEs concerns a CE marked device, then this meets the vigilance criteria and also needs to be handled under the Vigilance / Post-market surveillance (PMS)specific module. Furthermore, a coordinated assessment will also be available to allow coordinator actors (CAs) and Coordinating Member State (CMS) to harmonize their assessments of SAEs and device deficiencies to determine whether they modify, suspend, or terminate the CI/PS. A notification that the CI/PS has ended must be submitted to the CI/PS module within 15 days of the end of the investigation/study; and sponsors are also required to submit a CI/PS outcome report along with a summary within one year of the endof the investigation/study, or within three months of an early termination or temporary halt.
How about clinical investigations with combination products?
There are provisions under the MDR to allow an interoperability between EUDAMED and the EU database for clinical trials (CTIS) on medicinal products for human use, where there are combined clinical investigations of devices with a clinical trial under the medicinal products regulation (EU 536/2014). This functionality is not expected to be available when the CI/PS module first becomes available for use in Q4-2024.
EUDAMED is envisioned to touch every part of a device’s lifecycle, having a pivotal role in the implementation of the regulations. As such, having a good understanding of EUDAMED individual parts and as an all, will be crucial to bring and sustain a compliant device in the Union market.
Image: Rubin‘s Vase
All references assessed 17 January 2024.
1. https://ec.europa.eu/tools/eudamed/ – /screen/home