Medical Device Manufacturers Association
MDMA
The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies.
ID: 991141248676-03
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
Call for Evidence MDR / IVDR: Comments from MDMA (Medical Device Manufacturers Association) based in Washington DC with regulatory advisor in Brussels. MDMA welcomes the opportunity to submit evidence. The new regulatory framework should address the problems with the current system, which especially impact SMEs, as follows: -There should be recognition of the predominance of SME participation in the medtech sector. SMEs have responsible but lean regulatory departments and budgets both for pre-market approvals and post-market controls. -Following major investments by all stakeholders almost a decade ago, its important to carefully make legislative modifications that improve access, increase consistency and streamline the current regulatory system wherever possible. MDMA stands ready to serve and work with EU policy makers as a new or modified system is being developed. -All companies should have equal access to and consistent treatment from notified bodies both within a single notified body and among notified bodies. There should be predictable timelines and a first come first served mentality instilled in notified bodies. When questions or differences of interpretation arise there should be an accessible appeals process that can include a third-party arbiter such as a Competent Authority if needed. -The system for EU medicines approvals might provide some ideas for improving the consistency and clarity of the interpretation and implementation of medtech regulations. -Currently, regulatory processes, timelines and costs are highly variable between Notified Bodies. This inherent diversity requires greater transparency, predictability and consistency in the system starting with clear guidance, an effective NB consultation pathway and a third party appeals process when needed. -MDMA recognizes and appreciates the improvements that the European Commission has made. The Commission has been accessible, welcoming and interested in making improvements in the EU regulatory system. MDMA appreciates the transparency that the Commission is promoting regarding Notified Body activities, treatment and relative cost/charges which is very helpful to SMEs. -Nevertheless, the system must be improved and streamlined further. Future regulatory improvements by the EU have the ability to increase the attractiveness of the EU marketplace and also stimulate greater investment in the EU. For example, the EU should consider the creation of Trusted Regulatory Partners (TRPs) similar to the UK MHRA which will soon recognize prior pre-market regulatory approvals (or clearances) by TRPs such as the UK, Australia, Canada and the US (FDA) in whole or in part to help reduce pre-market regulatory duplication and cost for companies seeking to enter the EU market. -Within the EU, a third-party appeals process is needed within and among Notified Bodies and/or their regulators when disagreements occur in the interpretation or application of a regulation or associated guidance with an eye towards evaluating whether the additional request(s) contribute to improved patient safety or product performance. -The EUs forthcoming legislation should aim for simplification to reduce (not increase) regulatory complexity both for regulators and industry. Clear guidance/guidance documents can reduce variance in the interpretation of the MDR/IVDR. -Such regulatory improvements can reverse a concerning trend that has encouraged companies to withdraw many medical devices from the EU market because of the cost and complexity of the MDR/IVDR both for important legacy products and those used in low volumes in the EU. -In this regard, the requirement to re-certify products every five-years in the EU should be relaxed or abandoned especially if the EU continues to maintain robust post-market controls and surveillance. -Lastly the MDR should be the primary legislation to regulate medical devices with an AI/ML component. The rules should be addressed in the regulatory update.
Read full responseMeeting with András Tivadar Kulja (Member of the European Parliament)
3 Oct 2024 · Medical devices regulation