UK MHRA Publishes New 2024-2026 Roadmap of Future Regulations
11 December 2024
Team Notified Body: New MDR Training Session Available February 12, 2025
16 December 2024Today the Commission opened a consultation to evaluate the MDR/IVDR. The details are available: HERE
Background
The MDR/IVDR transition has been fraught and the implementation is still ongoing, many years later.
This initiative to evaluate the MDR/IVDR was already in the Commission’s plans for this year (as announced in this April 2024 update). That said, EU Parliament’s recent vote to revise the MDR/IVDR is presumably also helping propel this forward.
Industry now has a formal mechanism to provide structured feedback regarding the regulation’s impact on their business, customers, patients, and their EU market strategy – be it good, bad, or somewhere in between.
Objectives and Scope
The Commission outlines their scope and objective as:
- Gather feedback on the effectiveness, efficiency, relevance, coherence, and assess the performance of the legislation
- Look at the legislation’s impact on the availability of devices, including ‘orphan devices’, devices for small populations, and the development of innovative devices in the EU
- Consider the costs and administrative burdens, especially for small and medium-sized enterprises (SMEs)
- Assess whether the objectives of the regulations have been met in an effective and efficient way, whether it can address current and future needs, and whether it is coherent with the objectives of EU health policy and other policies
- Assess the benefits that arose from the new legislation
- Look at the potential for simplification
The evaluation will cover the period between the adoption of the legislation (5 April 2017) and 31 December 2024, for the areas that are already being implemented.
Commission adoption for this initiative is planned for Q4 2025.
How to Participate
The consultation can be accessed: HERE
The consultation period is: 12 December 2024 – 21 March 2025 (midnight Brussels time)
Participation details:
- It is open to all stakeholders. These include Notified Bodies, industry associations, economic operators, healthcare professionals, as well as the general public.
- To provide your feedback, you must sign-up for an EU Log-in, if you do not already have one.
- However, you can opt to have your feedback submitted anonymously in the questionnaire itself.
- Your feedback must be provided in one of the official EU languages.
- The Commission requests organizations and businesses taking part to register in the EU’s Transparency Register, which is a database that lists organizations that try to influence the law-making and policy implementation process in the EU.
- NOTE: the Transparency Register is primarily focused on lobbying activities and direct interactions with EU institutions, rather than participation in public consultations. i.e., SME manufacturers and other similar organizations do not need to register to participate in this consultation, although they may voluntarily do so.
