The repeated calls in recent months from many quarters for work to be carried out as soon as possible on the revision of the two regulations on Medical Devices (MDR) and In Vitro Diagnostics (IVDR) have been answered by the European Commission. In fact, a Call for Input for an Evaluation, addressed to the public and stakeholders, has been published on the Commission’s website.
There is until 21 March 2025 to send in your comments and observations. The outcomes of the targeted evaluation should support the Commission in better understanding the adequacy, efficiency and effectiveness of current regulations and whether they effectively meet current and emerging needs. Other objectives of the initiative include assessing whether the two regulations have European added value and are in line with other actions of the legislator.
The decision to launch a public consultation phase follows the numerous difficulties encountered in the transition between the old directives and the new regulations. In its invitation, the European Commission also points out that the timeframe for the re-evaluation of the two regulations under Art. 121 MDR and Art. 111 IVDR actually provided for a deadline of May 2027. The results of the consultation are expected to be announced by the fourth quarter of 2025. According to the Invitation, a factual summary report of the responses submitted should be published after the close of the public consultation.
The focus of the consultation
The focus of the targeted evaluation is on the period between the adoption of the new MDR and IVDR legislation (5 April 2017) and 31 December 2024, limited to areas already in the implementation phase. The main focus of the initiative is to verify whether the objectives set for the regulations can actually be achieved by the end of the transition periods, as extended, also in view of the current regulatory framework and the way it is implemented.
A critical issue, highlighted by several parties, at the centre of the evaluations is theimpact of the legislation on the availability of devices, including ‘orphan’ devices and devices intended for smaller patient populations, along with the development of innovative devices in the EU.
The Commission also announces attention to the issue of costs and administrative burdens, in particular for small and medium-sized enterprises, and to that of the benefits to be gained from implementing the legislation. A geographical impact assessment on the implementation of regulations in all EU Member States and in other countries, both within and outside the European Economic Area, should also not be missing.