Regulatory Rapporteur

 

February 2025 | Vol. 22 | No. 2

 

Introduction

MDR-innovation-compressed

The European Union Medical Device Regulation (EU MDR) 2017/745[1] superseded the previous Medical Device Directive (93/42/EEC) (MDD), with an aim of strengthening legislation across all member states, to ensure that medical devices are produced to high quality and safety standards.

The EU MDR intended to provide greater transparency to patients and end users alike, ensure greater control over supply chains, and provide greater levels of clinical data and risk analysis to guarantee that patients receive the highest levels of care, while reducing any potential risk posed to them.

However, since its publication in 2017, the EU MDR has encountered numerous challenges. These include delays, insufficient clarity and guidance and the concern that many devices may cease to be available on the market in the future. Furthermore, the prospects of novel MDs being introduced to the market in the coming years appear to be diminishing. This article aims to address this issue by examining the ongoing struggle between regulation and innovation.

Current challenges

One of the most immediately recognisable features of the EU MDR is its substantial size, comprising an additional 115 pages, 100 articles and five annexes compared to its predecessor. This sheer volume represents a significant challenge for MD start-ups seeking to introduce novel technologies to the market. In general terms, the resource required to acquire specialised knowledge, interpret regulations, implement compliance requirements and maintain adherence to a vast and intricate structure is a formidable undertaking that may not be feasible for those lacking the necessary expertise and resources.

The EU MDR also introduces many new requirements when contrasted with the previous EU MDD. These include the following:

  • A new scope
  • Stricter classification rules
  • General safety and performance requirements (GSPRs)
  • A unique device identification (UDI)
  • A European database for medical devices (EUDAMED)
  • Clinical evaluation and investigation
  • Stricter post-market surveillance (PMS)
  • Vigilance and incident reporting
  • Economic operators
  • Environmental and ethical requirements

 These new requirements aim to provide:

  • Improved patient safety, due to higher standards for device approval, PMS and comprehensive risk assessment
  • Increased transparency and traceability through the UDI, the EUDAMED and labelling
  • Adaptation to new technologies, for example Software as a Medical Device, nanomaterials and aesthetic devices
  • A focus on clinical evidence, for example using more robust clinical investigation which leverages PMS data
  • Supply chain accountability, through better defined responsibilities and the introduction of EU authorised representatives (EU ARs)
  • Proactive risk management throughout the product lifecycle
  • More rigorous incident reporting in faster timeframes, including the identification of dangerous trends
  • Patient and end user empowerment through increased access to technical documents, improved information for use (IFU) and labelling

While it would be challenging to find anyone within the industry who would oppose the advantages and benefits of these requirements, the difficulty lies in how these improvements are implemented. When the consequences of failure are so far-reaching and have the potential to derail modern healthcare, attention to detail is crucial.

The balance

Regulating MDs presents a significant challenge and the concept of establishing overarching rules that ensure consistency among a diverse group of products is not new. However, there are few examples of products that exhibit such wide variation. For instance, crutches, software and surgical sealants can all be influenced by the same set of rules, despite their differing usage. Consequently, potential innovation may be stifled in its early stages because the current regulation is based on MDs already on the market. This can make it challenging to develop novel or groundbreaking technologies that do not fit neatly into the existing framework.

The complexity of the regulation, which governs such diversity and creates challenges for manufacturers who aspire to innovate new MDs and treatments, is further perpetuated by those who enforce it. When assessing manufacturers, notified bodies (NBs) and their auditors may project their own unique interpretation of a regulation which may not necessarily align with the manufacturer’s own interpretation. While the fundamental principle of the EU MDR is that manufacturers are responsible for interpreting, justifying and demonstrating their compliance with the applicable requirements in their own way, a nonprescriptive regulation must remain generic enough to accommodate the inherent diversity of products it applies to. This leaves the regulation susceptible to varying interpretations and subsequent disagreements during the certification process.

The primary objective of the EU MDR is to ensure that MDs are introduced onto the market only after their efficacy and potential risks have been fully established. Additionally, the responsible manufacturer must adhere to all necessary requirements to maximise the positive benefits for patients while minimising any associated risks. While this objective may seem straightforward, it quickly becomes a delicate balancing act. The equilibrium between regulation and innovation hinges on the level of risk associated with each aspect. Insufficient regulation exposes patients to increased risks due to inadequate requirements imposed on manufacturers. Conversely, excessive regulation hinders innovation by imposing too many regulatory burdens on manufacturers, preventing the introduction of novel technologies and depriving patients of life-saving or life-altering treatments.

These opposing principles have far-reaching implications and the potential to significantly impact millions of patient outcomes. Consequently, great care must be exercised to ensure that the response to under-regulation does not become overly restrictive, potentially tipping the scales too far in the negative direction and increasing patient risks. This could result from the absence of theoretically safe medical devices due to the excessive application of regulatory procedures.

The reality

To facilitate the practical implementation of the new regulations, the Medical Device Coordination Group (MDCG) has issued a series of guidance documents since the emergence of the EU MDR. These documents cover a wide range of subjects within the regulation, at times providing valuable additional information, clarity and reassurance. However, the MDCG’s guidance has also faced criticism from the industry for occasionally further complicating matters, arriving too late or lacking sufficient detail.

For MD start-ups, the absence of clarity or explanation regarding the intricacies of the regulatory landscape hinders the emergence of new technologies to market. Within an industry plagued by a persistent skill shortage, ambitious entrepreneurs and daring company directors compete for the attention of regulatory and quality professionals, hoping to receive the best possible guidance and turn their innovative ideas into reality. Regrettably, due to the inherent complexity of the regulation itself, communicating its requirements to relevant stakeholders in a comprehensible and relatable way has become a highly valued skill in its own right, posing challenges for both established and new manufacturers.

If the regulation itself is confusing and the MD professional acting as a bridge between the regulation and key stakeholders is also uncertain, this often leads to inadequate resource allocation or a lack of seriousness regarding the timelines set out for addressing the requirements.

In terms of finding an appropriate balance between regulation and innovation, the outcome is not yet decided. However, it is important to keep sight of the fundamental fact that the industry required regulation initially to protect patients from being exposed to unnecessary harm.

Recommendations

As discussed above, harm can arise in numerous ways depending on the level of regulation in place and the skill is in maintaining the balance between regulation and innovation. Further consultation[2] is currently in progress, with the European Commission (EC) seeking feedback from industry stakeholders in order to evaluate the effectiveness of the EU MDR. This consultation provides an opportunity for the voices of the industry to be heard and it is the responsibility of the EC to ensure that feedback received is quickly acted upon to avoid a backwards step in innovation that may take years to bounce back from.

The EC has announced that recommendations as a result of the consultation will be implemented in the fourth quarter of 2025. The good news is that there are definitely ways to improve the situation and for everyone to benefit, including patients, manufacturers and the regulators. Examples of potential improvements could include, for example:

  • An improved certification process: New efficient pathways could be introduced, especially for low-risk devices, by reducing the administrative burden and providing clearer guidance, and providing a fast-track system for low-risk devices or devices certified under other global regulations
  • An increase in NB capacity: A streamlined NB designation process could be introduced, or increased funding and resources could be provided to existing NBs to increase their capacity
  • Greater support for small and medium-sized businesses (SMEs): Fee reductions, workshops or a specific SME EU helpdesk for compliance could be introduced
  • The introduction of a risk-based approach for legacy devices: Employing a more lenient approach to transitioning legacy devices would allow for a smoother transition, whilst still protecting the patient
  • Creation of new innovation pathways: Specific regulatory frameworks are required to address emerging technologies, establishing advisory panels to guide manufacturers early in the process
  • Increased consistency: This could be improved through the provision of harmonised implementation via central oversight of the member states and the provision of greater specificity in guidelines
  • Reduction of the PMS burden on low-risk devices: This could be achieved by using a scaled approach that better reflects the risk classification of the device
  • Improved clinical evidence: Real world evidence (RWE) and PMS data should be recognised as valid sources to demonstrate the conformity of a device with the applicable general safety and performance requirements (GSPRs); guidelines for incorporating RWE into EU MDR could be introduced
  • Revision of current compliance deadlines: Based on the current trajectory, the current implementation timelines will not be sufficient to provide end users and patients with the devices they need, without significant interruption
  • Better communication: Increased transparency in regulatory processes is needed, and direct channels should be established for manufacturers and regulators to address queries promptly. Real-time progress tracking should be employed for queries and submission to NBs

Next steps

Time will ultimately tell what the legacy left by the EU MDR will look like. However, while the industry acknowledges that the EU MDR was necessary and that it serves to strengthen safety, it risks stifling innovation to do so and needs to be streamlined, with clearer frameworks created and the necessary support provided for innovative technologies and SMEs.

The balance between regulation and innovation needs to be preserved and an imbalance in either direction will ultimately serve as a disservice to patients. Where regulators are responsible for adding and removing weight at one side, manufacturers do the same at the other, and only by working together is balance achieved. To succeed in bringing innovative technology safely onto the market, regulators and industry must communicate freely, take part in debate on the key challenges facing the sector and compromise where necessary to avoid exposing patients to unnecessary risk while simultaneously allowing them to receive access to the latest medical innovations.

 

References

[1] European Parliament and Council of the European Union (2017) ‘Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Directive 93/42/EEC, and repealing Council Directives 90/385/EEC and 93/42/EEC’. Official Journal of the European Union, L 117, pp. 1-175. (Accessed: 29 January 2025).

[2] TOPRA (2025) ‘EC announces evaluation of medical device and IVD regulations’. (Accessed: 31 January 2025)

Topics