Under the EU MDR, the new devices coming to market will face stricter regulations. We had the opportunity to attended a session on the topic: Bringing New Devices to Market Under the EU MDR, at the Virtual MedTech: EUMDR Exchange Conference, 2021. The session was conducted by Marianna Luppi -a veteran in regulatory space with more than 5 years of experience.
This presentation focused on the achievement of the first Conformité Européenne (CE) mark under Medical Devices Regulation (MDR) 2017/745. The Medical Device Directive (MDD) requirements largely remain the same under MDR. However, the shift to MDR is met with stricter changes, which are divided into the following:
- Stricter conformity assessment
- Stricter clinical evaluation requirement
- Stricter traceability
- Stricter transparency
Stricter conformity assessment
- Sponsors and manufacturers should determine the list of applicable standards and common specifications that reflect the state of the art.
- Ensure expertise to determine the adequate list of standards.
- GSPR conformity depends on the compliance strategy developed for the device.
Stricter clinical evaluation requirement (new rules governing clinical trials)
- Collection of available clinical literature
- Equivalence with other devices (if any) for which clinical data already exist and are accessible to the manufacturer
- Implantable medical devices and Class III medical devices must be subjected to brand new clinical trials (with exceptions in a few cases)
- Credible Clinical Evaluation Plan is essential to ensure clinical validation of the MDR requirements.
- Per Article 27 of the MDR, a new system of Unique Device Identification (UDI) is required for the identification and traceability of the medical devices.
- The quality system should support the UDI database creation.
- Each medical device needs a label with its unique code placed on it or the packaging.
- Information on products and the tests are to be made public on the EUDAMED database.
- The aim of the EUDAMED is to provide the public and the health professionals with the information related to medical devices.
- Ensure enough resources to compile the technical documentation of the medical devices to populate the EUDAMED.
With the MDR coming into effect, the manufacturers should plan and construct their strategy to meet the stricter requirements in terms of conformity assessment, clinical evaluation requirement, traceability, and transparency.
This article is part of the Virtual MedTech: EUMDR exchange conference, 2021 report. Get your full copy of this comprehensive report today!