A cost-effective approach to EU MDR compliance

PA Consulting medtech expert Hilde Viroux and PA life sciences expert Maggie Chan co-authored a series on EU MDR Compliance for Med Device Online with Dona O’Neil from Northeastern University. Click here to read their second article on how medical device manufacturers can comply with EU MDR activities in cost-effective ways.

In our previous article, “Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification,” we discussed the challenges a medical device manufacturer faces once EU MDR certification has been obtained. In this article, we will focus on being cost-effective in the face of the cost of compliance as it pertains to maintaining EU MDR activities.

The current economic climate

The current economic climate is characterized by a broad-based and sharper-than-expected slowdown, with inflation higher than seen in several decades. The cost-of-living crisis, tightening financial conditions in most regions, Russia’s invasion of Ukraine, and the lingering COVID-19 pandemic all weigh heavily on the outlook.

According to the latest data, the U.S. economy grew by 3.3% in the fourth quarter of 2023, driven by consumer spending and exports, but faced headwinds from rising wages and imports.² The EU and the Eurozone economies stagnated in the same period, as weak domestic demand and supply disruptions offset the recovery in external trade.³

The global economic situation is likely to remain challenging in the near term, as the risks of further geopolitical tensions, financial market volatility, and policy uncertainty remain high. The International Monetary Fund has lowered its growth projections for 2024 and 2025 and warned of the need for coordinated and decisive policy actions to address the multiple shocks and imbalances affecting the world economy.¹

As a result, many companies are looking into ways to reduce overhead and cost of goods. The additional tasks and resources required to maintain the compliance to EU MDR for their products often comes as an unwelcome surprise.

Key compliance considerations

To build on our previous article, EU MDR requires medical device manufacturers to regularly update the reports that support the technical documentation of their products. A summary overview is provided in Table 1. Although the reports have different update schedules depending on the risk classification, the PSUR will trigger the updates of the other documents as those documents all have interdependency.

Report under MDR	Class I	Class IIa	Class IIb	Class III / Implants
Clinical Evaluation Report [Article 61 (11), MEDDEV 2.7.1/4 (6.2.3)]	When needed	When needed or at least 2-5 years		At least annually
PMCF-Evaluation report [Article 61 (11), ANNEX XIV ‒ Part B (7)]	When needed	When needed or at least 2-5 years		At least annually
Summary of Safety and Clinical Performance [Article 32, 61 (11)]	N/A	N/A	N/A	Annually (if indicated)
Risk Management Report [Annex I (3)]	Regular systematic update
PSUR [Article 86 (1)]	N/A	At least every 2 years	At least annually	At least annually
PMS ‒ Report [Article 85]	When necessary	N/A	N/A	N/A
Technical file	Continuously

Table 1

Before EU MDR, the technical file updates typically happened when there were design changes to the device or a review from the notified body was expected. This is the main reason that working toward EU MDR compliance was such an effort, as product standards compliance and testing was not up to date.

EU MDR now explicitly requires manufacturers to keep the technical documentation up to date. Triggers for updates are the PSUR, CER, and PMCF report updates, documents that are all part of the technical documentation (EU MDR Annexes ll and lll) and standards updates that may require additional testing and updates to the General Safety and Performance Requirements (GSPR EU MDR Annex l).

The EU Commission has created transparency and several control mechanisms to determine whether a medical device manufacturer meets the new requirements, with strong focus on the higher risk classes devices, the class llb implantable and class lll devices.

Firstly, there is the EU database on medical devices, EUDAMED, where the manufacturer’s SSCP and PSUR will be posted. Any economic operator that has registered with EUDAMED will be able to see those reports, including the date issued. In principle, a competitor could monitor whether the documents have been updated annually as required.
Secondly, for class llb and lll devices, the PSUR has to be sent to the notified body, so the notified body will know immediately if there is a delay in generating the documents. In January 2024, the EU Commission issued a proposal³ to speed up the rollout of EUDAMED by making the operational modules such as economic operator and device registration mandatory as from 2025.

Since Notified Bodies have under EU MDR the power to force a manufacturer to recall products, and member states may impose penalties applicable for infringement of the provisions of the regulation (article 113), the risk of noncompliance has significantly increased. Noncompliance will not only have a financial impact but also can have a reputational impact.

An effective approach to balance compliance against cost

In order to reduce the risks of noncompliance, manufacturers should implement a robust approach to proactively mitigate the risks of business disruption from potential noncompliance. This will involve mapping out the current processes and the quality controls in place. A risk assessment will then identify those areas or processes that could contribute most to noncompliance. Appropriate controls can be put in place to ensure mitigation of the risks. Examples of such controls are rigorous internal audits to identify those areas that pose the highest risk and implementing a structured plan to mitigate those risks. Another control measure can be identifying and closely monitoring key performance indicators (KPIs) that ensure processes maintain in a compliant state.

Manufacturers should seek the ideal balance point between cost of compliance versus cost of noncompliance as shown in Figure 1.

When trying to be cost efficient, there are various options for manufacturers. The first step is product portfolio optimization. A critical analysis of product sales versus cost of compliance will identify those products where the cost of compliance may exceed sales. Unless the product is essential for the total portfolio, it is a candidate for optimization. Other cost reduction opportunities are process efficiencies, alternative resourcing models, and use of technology and AI.

Another important element in cost efficiency and compliance is maintaining an up-to-date schedule for generating the reports and keeping transparency of the various functions involved. The generation of the reports to ensure EU MDR compliance involve functions like clinical, medical safety, quality, regulatory, and R&D. One of the key elements to ensure compliance is that all these functions are working to the same agenda and priorities when it comes to ongoing compliance. However, these functions operate with different priorities and goals. Sustaining products in the market is typically not the main priority for functions that are focused on innovation and new product development. If the various contributors do not adhere to the schedule, there is the risk of divergence of data due to different time periods covered, creating a compliance risk. There is also the risk of rework, which increases cost.

Outsourcing the sustaining activities to a third party or to a lower-cost region might appear a viable option at first glance but may also have its challenges if not carefully planned and monitored. The risk associated with too much outsourcing is the loss of knowledge of the product due to insufficient feedback to the manufacturer on the product’s performance in the market. Delays in communication may be critical in cases of serious deficiencies or incidents. Solid oversight of the offshore activities, including regular training and communication, may mitigate these risks.

In both cases, when using in-house resources versus outsourced resources, carefully consider the processes for the post market surveillance activities to ensure consistency between the documents and establish a clear strategy and prioritization between the functions to avoid duplication of work. In addition, the appropriate controls, as mentioned above, should be put in place to ensure the processes remain compliant. The use of technology, including application of AI, may also help to further optimize workflows and reduce cost, in, for example, the conduct of literature searches.

Investing in solid process design and selecting the right technology to develop a robust quality management system aligned with an effective cost-reducing strategy is essential for medical device manufacturers to navigate the cost of compliance and mitigate the risk of noncompliance with EU MDR.

Conclusion

Although the current climate has many organizations looking to cost-reduce MDR maintenance activities, the question remains “are companies able to discern trimming a bit of fat versus cutting into essential functions to stay compliant with new MDR requirements”? The bottom line is that MDR compliance is not free, and industry will need to find a way to come to terms with this in order to keep compliant medical devices on the market. Moreover, a mindset shift is required that EU MDR is a “team sport” and although EU MDR remediation programs may be wrapping up over the next few years, this is not an invitation to separate back into silos. In our next article, we will explore further the potential operational models that manufactures may consider to strike a healthy balance between cost and compliance.