Regulatory trends in 2025.
Medical technology will face regulatory changes in 2025, and these will bring positive momentum for developers and manufacturers. In the US, the Food and Drug Administration (FDA) is aligning its quality management requirements with the internationally recognized ISO 13485 standard, while the UK is harmonizing its medical device regulations following Brexit and placing greater emphasis on the mutual recognition of existing approvals. The aim is to simplify approval procedures and accelerate market access without compromising safety.
In early 2024, the FDA decided to largely replace its Quality System Regulation (21 CFR Part 820) with references to ISO 13485:2016. With this harmonization, the FDA aims to align its quality management system requirements with those of other authorities. The stated goal is to “reduce the regulatory burden on manufacturers.”
Fewer national special requirements mean that manufacturers will no longer have to maintain two separate quality systems (one for the FDA and one for the rest of the world). The result is less duplication of work and bureaucracy, and more efficient processes. Ultimately, the FDA hopes that this will also lead to faster access to innovative, safe products for patients in the US.
The cards are also being reshuffled in the UK. The British Medicines and Healthcare Products Regulatory Agency (MHRA) is planning an “International Reliance Scheme” under which certain medical devices could be approved on the basis of certifications already obtained from third countries (such as the EU or the US). An additional British conformity assessment procedure (and the UKCA label) would then no longer be necessary.
In other words:
What has proven itself in one country should not have to go through all the bureaucratic hoops again in the UK.
For manufacturers, this means clearer approval processes and fewer repetitive testing procedures on the way to the UK market.
International developments confirm our approach of integrating regulatory requirements into product development right from the start. We help our partners and customers to consider all relevant standards and approval requirements as early as the design phase. The current changes at the FDA and MHRA prove that those who align their quality management internationally at an early stage will face fewer hurdles later on. We design development processes in such a way that the resulting medical devices are “globally ready” – i.e., ready to be approved in multiple markets without the need for fundamental changes.
A very simple but accessible example for us is technical documentation! Instead of putting together separate documentation packages for each country (which would mean enormous additional effort), we plan the documentation strategically for multinational use from the outset.
Our customers receive one thoroughly prepared set of documentation that meets the requirements in Europe, the US, and other target markets simultaneously. This means that EU MDR dossiers and FDA approval documents, for example, can be designed to be largely identical. Duplication of work in the approval process is avoided, and new products can be launched in different regions almost simultaneously. This ensures in advance that no important evidence is missing when entering new markets.
Our guiding principle here is that quality pays off. We do not see regulation as a necessary evil, but rather as an integral part of a successful development project. If you take a structured approach to regulatory requirements from the outset, compliance becomes a competitive advantage. A medical device that meets high quality and documentation standards early in the development process will pass the approval process more smoothly and reach patients faster. At the same time, it is better positioned globally because it meets the common requirements of various authorities.
We are convinced that proactive action in regulatory matters is the key to sustainable market success. Thus, regulation is not an obstacle, but a strategic advantage if approached early and with a sense of proportion. With this understanding, we support our customers:
Together, we lay the foundation for innovations to succeed in many markets through solid quality and compliance, rather than failing due to formalities.
