In January, the European Commission published a proposal for another amendment to the MDR and IVDR, which brings a number of major new features. The change with perhaps the biggest impact is the phased roll-out of Eudamed, with operators having to fulfil registration obligations through these modules six months after their official announcement of functionality. Up to now, it has been planned to wait until all modules are fully operational. Given that five of the six modules are due to be ready this year and work is only just starting on the last one, the proposal presented seems very reasonable. European healthcare providers are waiting impatiently for the Eudamed database to be completed, as it is a mercy for them view of the basic building block for successful implementation of UDI records.
The second significant change, which affects both the general medical devices and IVD segments, is the introduction of a completely new obligation for manufacturers of critical medical devices and IVDs to report in advance any shortages in the supply of their products. This obligation will hit the affected manufacturers hard from a regulatory and commercial perspective. The third set of changes relates only to the IVD area, where the Commission seeks to implement the same principles of conditional extension of the transitional periods for the marketing of legacy devices in the EU as contained in last year's Regulation (EU) 2023/607, which applied to general medical devices. Manufacturers of legacy devices under the IVDD must have a quality management system (QMS) in place under the IVDR by 26 May 2025 at the latest. The manufacturer must submit an application for new device certification by 26 May 2025 for all devices that were subject to certification under the IVDD, as well as by 26 May 2026 for Class D IVDs, 26 May 2026 for Class C and 26 May 2027 for Class B and Class A sterile. The manufacturer must enter into a written contract for new device certification no later than 26.9.2025 for all devices that have been subject to IVDD certification, as well as by 26.9.2026 for Class D IVDs, 26.9.2026 for Class C and 26.9.2027 for Class B and Class A sterile. If the above conditions are met, the transitional periods for the marketing of legacy devices will then be extended until 31.12.2027 for all devices that have been subject to IVDD certification, and further for Class D IVDs, until 31.12.2028 for Class C and until 31.12.2029 for Class B and Class A sterile.
The proposal is now going through the legislative process with a view to final approval and publication in the Official EU Journal by May this year.
Author: Jakub Král