On 23 October 2024, the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
This resolution acknowledges that the MDR and IVDR were adopted to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices in the EU, to ensure higher standards of safety, transparency and clinical performance, while also fostering innovation in the sector. However, it is also acknowledges that significant challenges have been encountered in implementing the MDR and the IVDR. These include delays, shortages, and difficulties in navigating the regulatory procedures. The particular impact on small and medium sized enterprises (SME) and on patient care are highlighted.
The lack of harmonised procedures for Notified Bodies, and the lack of harmonised interpretation of the MDR and IVDR between Notified Bodies, is also noted, and the fact that this leads to unpredictable timelines for certification and market access.
The Parliament resolution therefore seeks to address some of these difficulties.
Proposed changes to the MDR and IVDR
As set out in previous blogs, the transitional periods for both the MDR and IVDR have been extended a number of times. However, the difficulties remain, and the Parliament now calls on the Commission to take various steps, including to:
- propose relevant delegated and implementing acts to address these challenges, including revision to the MDR/IVDR
- make use of non-legislative tools to resolve divergent interpretations
- harmonise such provisions and ensure consistency across the EU
- establish a clear working definition of ‘orphan device’ to facilitate the adoption of harmonised measures across the EU
- introduce adapted rules for orphan and paediatric medical devices
- to consider fast-track and prioritisation pathways for the approval of innovative technologies in areas of unmet medical need and for devices linked to health emergencies
There are also various comments about and requests to Notified Bodies, although given Notified Bodies are independent bodies designated by the national competent authorities, the EU Parliament and Commission have no direct authority over or role in the operation of Notified Bodies. These requests include to:
- increase transparency in fees and fee structures
- increase capacity “to meet market demand”
- create transparent and binding timelines for procedural steps in conformity assessment
Some of the Parliament’s “calls” to the Commission are rather general in nature, but some are focused on specific changes the Parliament would like to be considered, such as “the need to eliminate the unnecessary re-certification of products” given the view that “certain product updates or adjustments should not necessarily lead to an entire re-certification of the product”. The Parliament also “calls for an urgent full implementation of EUDAMED” in order to enhance transparency, provide better access to information, and enhance coordination between Member States.
In terms of timing, the initial call “to propose delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment” is requested by the end of Q1 2025. The others requests have no such time period attached.
The resolution is an important step forward in trying to resolve some of the difficulties with the MDR and IVDR. However, as the Parliament cannot initiate amendments to the MDR or IVDR itself, we will need to wait for the Commission’s response before the full impact of this resolution is known.
Response from MedTech
MedTech Europe has welcomed the Resolution’s attention on bringing predictability, support for innovative, support for SMEs and eliminating unnecessary administrative burdens. The organisation also suggests “a single, dedicated governance structure to oversee the regulatory system”, which is a proposal that has received increased attention given the lack of harmonised decisions or oversight of Notified Bodies, but was not included in the adopted resolution. MedTech Europe has called on the European Commission to do its utmost to resolve these challenges and bottlenecks “via any means”.