The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR). This plan gives an overview of the implementation of the IVDR, stating that it has proven to be a very challenging task for stakeholders and authorities. Despite this, remarkable progress has been achieved, from the current designation of 12 IVDR Notified Bodies in NANDO to the setting up of the UDI system and the designation of five EU reference laboratories (EURLS).
This document details the status of the IVDR implementation, highlighting outcomes achieved and indicating which documents we can expect the MDCG to release in the future, according to the priority objectives of public health, patient safety, and transparency. The priorities are divided between a first set of actions that are vital for devices to have access to the market and a second set of legislation and guidance documents that support IVDR implementation.
First set: essential actions
As part of the IVDR implementation, both the Commission and the Member States will continue to carry out requests for updates, as we have described in previous posts. This involves carrying out market monitoring exercises as well as an analysis of hypothetical scenarios for an urgent response to a health crisis. In addition, competent authorities are expected to continue to increase notified body capacity.
Second set: high-priority actions
Much of the priorities set in this area have been met already. Therefore, we will only focus on the aspects that can be expected, such as EURLs, notified bodies, performance evaluation, and harmonised standards.
Regarding EU reference laboratories, there are discussions about a solution to practical issues on the operational aspect of EURLs. Moreover, the MDCG is expected to simplify the process of adding codes to existing designations of notified bodies and to provide a general framework on certificates subject to conditions to facilitate the certification process, by the second quarter of 2024.
On performance evaluation, the current focus is centred on providing Q&A guidance on performance study applications and notifications to solve any challenge sponsors face. Furthermore, as part of the COMBINE project, the analysis phase on the challenges by sponsors conducting combined studies is expected to be finalized by the first quarter of 2024.
Finally, a fifth publication of harmonised European standards can be expected also by the first quarter of 2024.
You can read more about this in our IVDR – MDCG section!