Ideas for medical device regulations overhaul proliferate

One day after the European medtech industry proposed short and medium term actions needed to support public health, patient safety, and the future sustainability of Europe’s health systems, concluding that “broad and comprehensive reforms” were needed, the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) meeting discussed similar measures proposed by several member states, led by France and Germany.

The Medtech industry approach proposed:

Short-term measures: To be implemented without delay with sufficient legal weight to achieve their intended objectives:
• Bringing predictability to timelines and costs in technical documentation assessment and change control
• Introducing an accelerated pathway for breakthrough innovation
• Adapting certification to follow a life-cycle approach, i.e. removing the requirement to renew certificates every 5 years
• Ensuring harmonised interpretation and application of MDR and IVDR requirements by developing technical documentation harmonised methodology
• Making sure that MDCG 2022-14 delivers on its original goals
• Enabling structured dialogues before and during conformity assessment
• Working towards allowing electronic instructions for use (e-IFU) for all medical technologies and embracing digitisation more broadly
• Promoting global convergence of regulations, by for example joining/adopting the Medical Device Single Audit Program (MDSAP)

The full industry paper can be accessed from here, including the suggested medium term measures.

The EPSCO meeting, on the other hand, was presented with an alternative set of short term objectives, proposed by nine member states, including:

• Centralizing EU device regulatory management functions to the EMA, which is in “in an excellent position to extend to…medical devices” and thereby support the practical application of the MDR and IVDR. An EMA Medical Device Coordination Group secretariat would support the development of MDCG guidance documents. Certain administrative functions would be transmitted to the EMA, which would also have a coordinating function for device and IVD safety issues. More centralization at EMA level for Eudamed is also proposed.
• Transparent and predictable timelines for notified body certification, with stop-the-clock options. The EMA should provide a process of supervision to notified bodies.
• Adapted IVDR and MDR certifications specific to certain patient populations to avoid high administrative burden and to prevent new products being kept from the market. The EMA, for instance, could define such product groups. For products already on the market, “an agency” could be called on to provide scientific data and advice on required levels of clinical evidence.
• A new pathway for product certification and early access to innovations, to help ensure EU global competitiveness. Notified body certification processes are “quite lengthy,” and pathways for breakthrough technologies that address unmet need should be established with EMA scientific and advisory support, and possibly a regulatory sandbox approach.
• Proportionality. Products should be recertified (say, every five years), but the exercise should focus only on new aspects of the product and safety issues linked to post market surveillance/vigilance. Recertification should be proportionate to the product’s risk class.

It remains to be seen which ideas reach any eventual regulatory reform during the next 12 months as manufacturers continue to struggle with significantly higher costs and much more complex conformity assessment processes.

It must be noted, however, that none of the potential reforms listed above include addressing what appears to be the most frustrating element of the new regulations, this being the overburdensome requirement for clinical data, no matter what the device.