Szymon Kurdyn - DQS Medical Devices, Frankfurt a. M.
The implementation of the Medical Device Regulation, Regulation (EU) 2017/745 (MDR), marked a turning point in medical device regulation within the European Union in 2017. Despite the good intentions to increase the safety and effectiveness of medical devices, one might easily conclude that the MDR primarily presents a regulatory jungle with high costs and little benefit for manufacturers. However, this would only be partially and superficially correct, as there are interesting regulatory interactions with other markets under the MDR and elsewhere.
Programs like the Medical Device Single Audit Program (MDSAP) illustrate this. Initiated by the International Medical Device Regulators Forum (IMDRF), this program aims to enhance the efficiency and effectiveness of regulatory review processes for medical devices. For manufacturers, this can significantly simplify processes around quality assurance and approval. Instead of undergoing individual audits for each country, an MDSAP audit covers the fundamental regulatory requirements for Australia, Brazil, Canada, Japan, and the USA.
A Successfully Completed MDSAP Audit is a Trust Signal
This not only saves time and resources but also minimizes operational burdens. Another effect is that a successfully completed MDSAP audit sends a strong trust signal to regulatory authorities regarding a manufacturer’s quality management and compliance structures. This can shorten the time to market. The program has now established itself as a fixture in the regulatory landscape. It is mandatory only in Canada.
Work on the MDSAP has shown that even previously incompatible approval system requirements can be integrated. For manufacturers, it provides an excellent template for restructuring their own QM systems. An extension to include other approval programs is possible on a modular basis. The focus can be on Europe or, for example, the National Medical Products Administration (NMPA) in China – and perceived regulatory chasms are no longer seen as insurmountable.
FDA and EU-MDR: Closer in Content Than One Might Think
Since the introduction of the MDR, the FDA and Europe, for example, are now much closer in content than in the past. Currently, the U.S. medical device market is very well suited for quickly gaining initial experience with innovations and new medical devices. This is because the FDA allows rapid product approvals under the so-called 510(k) process if technical parallels can be drawn to already approved products. The agency focuses on downstream market surveillance measures, such as manufacturer inspections and the incident reporting system.
The MDR, on the other hand, always requires a thorough pre-assessment of manufacturers and their products. It largely excludes "grandfathering" of previous approvals. This means that access to the EU market is considered time-consuming and costly.
Advantages of FDA Procedures – and What the Agency Changes
Additionally, the FDA has recently succeeded in making approval processes transparent and predictable in their outcomes. An aggressive and high-quality information policy has contributed to this. As a result, the U.S. medical device market has positioned itself as an attractive alternative compared to the European approval system, especially for the initial approval of innovative medical devices.
At the end of January 2024, the FDA also announced that it would explicitly consider the internationally established ISO 13485 standard for quality management in its approval process. This is a consistent step and a clear signal to manufacturers about future developments in this area. It is expected that other jurisdictions will follow this initiative and update their approval programs accordingly to keep up with these global standards. For manufacturers, this means that FDA approval, taking ISO 13485 into account, can facilitate access not only to the USA but also to other countries, as the harmonization of requirements progresses globally.
Not Just MDSAP: MDR Certification Also Opens Markets
Apart from the differences between the USA and Europe for innovative products, the European certification system according to the EU-MDR also offers opportunities to reach other markets. Rapid growth potential arises, for example, when a company leverages a European CE marking to access key markets like Australia – or markets in Switzerland, Turkey, or the United Kingdom.
However, there is a catch to the numerous opportunities: One can only achieve a lot if one knows how to use their time wisely. As requirements become more complex, it is increasingly important for manufacturers to adopt an agile approach to regulatory topics and developments. The era of universal solutions ended with the introduction of the MDR. Solutions once considered universally applicable now need to be critically re-evaluated to optimize the cost-benefit balance for a specific company or product. Manufacturers must now review their implementation strategies from an overarching perspective. Aspects such as regulatory requirements, quality management, clinical evaluation, and marketing must be considered in context. This is the only way companies can ensure that their products not only meet regulatory requirements but also reach the market effectively and efficiently.
Expert Teams and Regulatory Intelligence Are the Future
The future, therefore, belongs to cross-functional expert teams who continuously exchange views on regulatory affairs and clinical affairs, including clinical users, medical writing, product development, compliance, and sales. These teams can be fully in-house or formed with external support, at least initially.
Investments in "Regulatory Intelligence" will also prove increasingly beneficial – investments in collecting, analyzing, and disseminating information on regulatory requirements, strategies, and guidelines. Regulatory Intelligence will help detect relevant trends and changes early and make strategic decisions based on this knowledge.
Regulatory Intelligence: Also Interesting for AI Topics
This applies to dealing with innovative technologies such as artificial intelligence, as well as new sterilization procedures or the implementation of a proactive market surveillance system. Economically successful companies will increasingly stand out through a holistic view of regulatory frameworks – and through their ability to navigate various regulatory environments agilely and competently.
