Professor Klar, the new European Medical Device Regulation (MDR) has been in effect since earlier this year. Is the AMWF happy with the results?
Ernst Klar: Before I can answer this question, you first need to understand how this revision came to be. Several years ago, a scandal surrounding defective and poorly produced breast implants clearly showed the need for improvements in patient safety and benefit/risk assessments for medical devices. This was addressed by the European Parliament and the European Commission. The intention was to revise and tighten the then effective Medical Device Directive. The new Medical Device Regulation is therefore based on an existing Directive. Over the past years, we strived to ensure that the MDR is not impeding innovations and to prevent constraining regulations. We did not want to tip the scales so to speak. The MDR was now adopted in June of this year and includes basic tenets of several opinions delivered by the medical societies. We noted that many of the aspects we requested have been incorporated. Now it’s up to the individual countries to implement the MDR and adapt it to their settings. We believe this is a great advancement that protects patients but also allows for innovative changes. We are all in all relatively satisfied with the legislative text.
The AMWF still wants amendments. What is the problem?
Klar: Requesting amendments to the newly submitted legislation now would not be productive. That’s why we encourage taking advantage of the MDR’s wiggle room and flexibility of interpretation. The industry was worried that the process of moving from development status to implementation and production would be disproportionately prolonged. As a medical society, we don’t quite see it this way since the law leaves discretionary wiggle room to apply reasonable elements of assessment. This is a graduated assessment defined by very accurate definitions of methods of preclinical testing with subsequent implementation in hospitals and applicable methods to measure both incommensurable breakthrough innovations and long-term progress. The fear that randomized controlled trials (RCT) that take a long time, are extremely intricate and costly would be extensively mandated was unfounded. Instead, there are specified smart alternatives including the possibility of individual application and data collection from small sample sizes. Pretesting can be done before an innovation is widely used in medical practice. This means the graduated approach we suggested two and a half years ago, is well reflected in the final version of the MDR.
Are you or rather the medical societies up to the challenge to manage these assessments?
Klar: One new MDR requirement that causes problems for manufacturers is the so-called scrutiny process. Previously, the conformity assessment of technical innovations was bound to the notified bodies. These might be different for every country; in Germany, these notified bodies are the TÜV (Technical Inspection Association) and DEKRA. Until now, when a product received the seal of approval, is was considered to be conforming. Now, a scrutiny mechanism can be applied for individual cases subject to special requirements. That means experts are called in to conduct an additional review. It particularly considers the medical perspective but also includes technical aspects. This offers patients added protection. These different approaches need to be balanced since too much control can disrupt the manufacturing process. Building applicable teams of experts to perform the scrutiny process is a challenge that we as medical societies want and have to take on since we have the required experts available. Another challenge for us is to provide feedback to manufacturers on product-related research. We need to ensure that continuous compliance with registration requirements delivers transparent results that also promptly lead to actual responses from manufacturers. These can cause a variety of actions, ranging from a product modification all the way to the stop of production.
You are working in a hospital. Can you already see any impacts of the new Directive in your daily work?
Klar: We notice an additional workload since we need to ensure that the medical devices we end up using can be seamlessly and individually tracked. Having said that, we gladly support this since we now need to be able to identify the respective patient within 72 hours based on the documented serial numbers. This enables a quick recall if danger needs to be averted. However, this noticeably also increases everyday documentation.
The plan is to implement the MDR in all European countries. What are the deadlines for this?
Klar: The implementation timeline to perform the country-specific adaptations is two years. However, content modifications must not be made.