Over the past year, our experts have dealt with numerous regulatory issues in a total of 26 blog posts. These texts explored both current Regulatory Affairs trends as well as the essential tools used in our daily work. And they also highlighted various areas in which our colleagues have specialized in order to provide our clients with the best possible support.

These contributions covered a wide range of topics, including current MDCG guidance on Periodic Safety Update Reports (PSUR), new transitional provisions for MDR and IVDR following Regulation (EU) 2023/607, as well as deep dives into subjects such as nanomaterials and biocompatibility, the intended purpose of medical devices, or the interfaces between risk management and usability.

The fascinating world of Regulatory Affairs

In 2024, we will once again take you on a journey through the exciting world of regulatory affairs surrounding medical devices and in-vitro diagnostics. In this post, however, we would like to take the opportunity to look back and toward the future a little more generally. If you are also involved in regulatory affairs, you will no doubt recognise some of the things that occupied us on our MedTech journey in the past year.

2023 was a particularly dynamic year in our industry. Ongoing uncertainties due to new transitional provisions in MDR and IVDR, new standards, and guidance documents may be routine for the Metecon team – but pose a challenge for many manufacturers. For some of our customers, the year was therefore characterised by uncertainty, but for others it was also a major breakthrough.

At Metecon, we are grateful to experience the many facets of this dynamic industry with our clients, always driven by our shared goal of bringing innovations to the market safely and effectively.

When every detail counts, trust is key: trust in the quality of our work, trust in the expertise of our colleagues, and above all, trust in the safety and reliability of medical devices and in vitro diagnostics entering the respective target markets with our support.

In 2023, Metecon focused on strengthening and expanding this trust by continually updating our knowledge, evaluating our work, questioning our approaches, and engaging in intensive professional exchanges with other stakeholders in the field of Regulatory Affairs.

Quality management and globalization

It is challenging to single out the topics that have occupied us the most. However, we would like to highlight just two of them here.

The question of how our customers can focus on the quality of their products right from the development phase in order to guarantee the highest safety standards throughout the entire product life cycle is always central to us. We provide customised solutions to give our customers a competitive advantage. And we focus on raising the awareness of all stakeholders for the necessity and the entrepreneurial advantage of the effective and efficient processes within a functioning quality management system.

Looking beyond the EU to sometimes vastly different regulatory requirements is not only crucial for quality management but also for various other regulatory fields. Regardless of the regulatory domain, manufacturers seeking access to new international markets may encounter unexpected challenges. Globalization requires a thorough analysis and adaptation to specific market conditions, and our goal at Metecon is to facilitate this market access.

The founding of Metecon Schweiz GmbH last summer was particularly exciting in this context. Our sister company is not only able to act as a CH Representative but also supports Swiss clients in gaining market access in the European Union. We were warmly welcomed by the Regulatory Affairs community in Switzerland, and the experience of the past months has shown not only a significant need for support but also a willingness to collectively ensure a stable and reliable supply of medical products.

What Regulatory Affairs trends do we expect in 2024?

This year, we will focus our attention on several thematic fields, some being industry-wide trends, while others stem from the specific needs of our clients.

Quality management and innovation

How can we work with our customers to further improve quality right from the product development stage in order to meet increasing safety requirements and drive innovation?

Global market access management

What new regulatory requirements will we face internationally in 2024, particularly concerning the EU and developments in Switzerland through Metecon Schweiz GmbH?

The role of the PRRC (Person Responsible for Regulatory Compliance)

How can CEyoo GmbH better serve our customers as a legal manufacturer or EC Representative, especially by optimally assuming the role of the Person Responsible for Regulatory Compliance (PRRC)?

Post-Market Surveillance

What new trends and requirements are emerging for post-market surveillance? How can we responsibly ensure that our clients meet the diverse requirements of international markets?

Innovation and Regulatory Compliance

How can regulatory compliance keep pace with advancing technologies, especially in the fields of digitization and AI?

Understanding Challenges as opportunities

As we reflect on the past year and look ahead to 2024, we consciously remember that challenges always come with opportunities. What is perceived by manufacturers as a regulatory hurdle generally stems from the intention of ensuring the supply of safe and useful medical products. And what initially appears as an insurmountable mountain of documentation requirements can, with a structured approach, become the foundation for agile action under adverse market conditions. Therefore, we aim to develop tailored and innovative solutions with our clients, meeting their requirements and ideally advancing them strategically through increased resilience.

We invite you to share your expectations and challenges for 2024 with us. What issues currently move you in the field of medical technology? What support would you like to receive from us?

We value a professional exchange and look forward to working with you to set the course for a successful year – as your reliable partner in all areas of Regulatory Affairs.

Best Regards