The European Commission (EC) has updated its rolling plan for adopting implementing acts ahead of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).
Due to the COVID-19 pandemic, the implementation of MDR has been delayed by one year. The establishment of Eudamed under MDR has also been delayed by two years.
The rolling plan lists various upcoming implementing acts concerning the re-processing of single-use devices, specifications for devices without a medical purpose, the designation of expert laboratories, designations and rules pertaining to EU reference laboratories for in vitro diagnostics (IVDs), Eudamed support and maintenance, and common specifications for high risk (Class D) diagnostics.
The specifications for reprocessing single-use devices are anticipated in Q3 2020. They will cover risk management, validation, product release and performance testing, quality management system, incident reporting and traceability. Common specifications for groups of devices listed in Annex XVI of the MDR, which do not serve a medical purpose, are expected to be adopted in Q4 2020. Implementing acts on the designation of expert laboratories under MDR Article 106(7) and establishing common specifications for Class D IVDs are planned for Q3 2020.
The EC will adopt an implementing act providing detailed arrangements necessary for the establishment and maintenance of Eudamed in Q4 2020. Eudamed may go-live from the moment a notice is published in the Official Journal of the European Union, following a positive independent audit. This is expected to happen in 2022.
Furthermore, six Eudamed modules will be made available as soon as each module becomes operational.
Click here to view the MDR and IVDR implementing measures rolling plan.