The implementation of the Medical Device Regulation (MDR) has brought significant changes and challenges to the health sector.

While the regulation aims to ensure the safety and efficacy of medical devices, which is welcome, it has also introduced complexities that may impact supply chain, from startups to large manufacturers and distributors.

However, through collaboration and a balanced approach, we can navigate these challenges effectively.

Systemic challenges: supply chain

One of the primary challenges posed by MDR is its potential impact on supply chain. The regulation mandates stringent requirements for clinical evaluation, post-market surveillance, and traceability, which have increased the workload and resource need for all stakeholders.

New obligations, such as import labelling and documentation verification, add further complexity and resource demands to maintain supply chain traceability. These requirements necessitate comprehensive documentation and continuous monitoring, leading to potential delays and disruptions in the supply chain and additional support.

Additionally, the European Commission’s need for early notification of supply interruptions adds further complexity.

MDR has increased financial and resource costs for companies requiring additional clinical trials, enhanced quality management systems, and more regulatory submissions. Some nuances depending on company types include:

• Startups: Often lack resources, facing high compliance costs that can delay innovation and market entry
• SMEs: Despite more support, they struggle with extensive documentation and continuous post-market surveillance
• Manufacturers: These must adjust their compliance processes, which involves investment. Importantly, manufacturers must reconsider supply of certain lines due to MDR and processes involved. Some will have similar replacement codes however, in certain circumstances, others don’t and the provision to the market may be effected.
• Distributors: Distributors, of which Ireland has many, face a unique set of challenges. They must ensure that all products they handle comply with MDR, which involves verifying documentation and maintaining traceability throughout the supply chain often absorbing increased costs. In addition they must ensure their own compliance, adding another layer of financial burden.

As a representative from BD, which uses distributors to get some of its products to market, and Board member Patrick Ferris noted, “The additional costs imposed by manufacturers due to MDR compliance are significant. Distributors must also ensure our own compliance, which adds another layer of complexity and cost.”

MedTech Europe’s position and advocacy

MedTech Europe supports the regulation’s objectives but has highlighted the need for reforms to address systemic inefficiencies and ensure a balanced approach.

In a letter, sent to the outgoing Commissioner Kyriakides in September, MedTech Europe, with support from HealthTech Ireland’s regulatory working group and other trade associations across Europe, noted these issues faced by industry, including limited capacity of notified bodies and the inconsistent interpretation of MDR across member states.

MedTech Europe supports the objectives of the regulations to establish a “robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation”.

However, they note that despite progress, the IVDR and MDR have still not fully achieved their goals. While considerable work has been done by all stakeholders to address the short-term implementation challenges, they note there are structural issues in the regulatory system which make it slow, unpredictable, costly and complex, and lacking in agile pathways for innovation.

They highlight these structural issues cannot be solved through the implementation of IVDR and MDR alone.

To support best outcomes, MedTech Europe, with other national associations, has called for comprehensive reform to make the regulations work for patients and European health systems stating that reform should address the three key areas of efficiency, innovation and governance, all while maintaining the device safety and performance.

The need for balance and consistency

HealthTech Ireland fully supports the goals of MDR in ensuring patient safety and product efficacy. There is however a pressing need for balance, harmonised interpretations and consistency in the regulation’s implementation across the EU with member states.

Different interpretations of MDR can lead to confusion and uneven compliance. Ireland, known for its stringent adherence to MDR, often faces higher compliance costs compared to other countries.

This disparity underscores the need for a harmonised approach to regulation across the EU.

Commitment to compliance and safety

HealthTech Ireland is committed to supporting its members in navigating the complexities of MDR. Through collaboration with the Health Products Regulatory Authority (HPRA) and the Health Service Executive (HSE), we provide another important perspective to ensure compliance and safety as well as avoiding unintended consequences.

Our regulatory working group continuously reviews and contributes to policy discussions, advocating for practical solutions that balance regulatory rigour with operational feasibility.

As a representative from DCC Vital, a leading healthcare distributor, stated, “Our collaboration with HealthTech Ireland and the regulatory bodies has been instrumental in ensuring we meet MDR requirements while maintaining operational efficiency.”

Ultimately, while MDR presents significant challenges, it also offers an opportunity to enhance the safety and quality of medical devices.

By working together and advocating for balanced and consistent implementation, we can ensure that the regulation achieves its goals without stifling innovation or burdening companies disproportionately.

HealthTech Ireland remains dedicated to supporting its members and the healthcare system through this transition, fostering a collaborative environment that prioritises patient safety and industry growth.

Susan Treacy is the CEO of HealthTech Ireland. This article has been written in conjunction with Claire Shannon, with contributions from Patrick Ferris BD and Sarah O’Neill, DCC Vital.