From 26 May 2021 the new Medical Device regulation applies and covers all medical devices, in-vitro diagnostic (IVD) medical devices and their accessories. In addition, certain previously unregulated aesthetic products will be covered.
Both medical devices and IVD medical devices are divided into four risk classes. Depending on the risk class of the product, a different conformity assessment procedure is required before the product can be placed on the EU market. In case of medium or high-risk classes, Notified Bodies are involved in the process.
In the Risk Analysis Report foreseeable serious adverse events and potential risks are listed and assessed. Reference Safety Information, identifying anticipated serious adverse device effects, is often included in the Investigator’s Brochure or risk analysis report. These documents are part of defining the products’ safety and serve as the basis for safety evaluations. During a clinical investigation, safety needs to be assessed by both Investigators and manufactures/Sponsor and includes assessment of device deficiencies, adverse events and serious adverse events.
EUDAMED is a comprehensive database developed by the European Commission to implement regulations on medical devices and IVD medical devices to give a living picture of the lifecycle of all products available on the EU market. Currently, to comply with regulatory requirements, all safety reporting is done directly to the local authorities while the development of EUDAMED modules is being completed. All reportable events need to be reported within regulatory defined timelines to the authorities in each country where the trial is performed.
CTC’s Pharmacovigilance department can assist you in all aspects needed for safety reporting under a clinical investigation aimed to generate data for CE labelling or for CE labelling outside the current CE label or outside intended use of the device.
In line with regulatory requirements, our Medical Monitor will take care of all aspects of safety surveillance and medical assessment and our Safety Officer will guide you and execute all tasks needed for safety handling and reporting during your whole clinical investigation process.