In recent months, the regulatory sector has increasingly focused on topics related to MDR and IVDR.
In the latest edition of Sobel News, we covered a European Union-commissioned study analyzing the impact of MDR and IVDR on the medical device market in the region.
Now, at the end of January, Brussels hosted discussions on potential revisions to MDR and IVDR.
This update, along with important regulatory developments in the United States and China, is the focus of this article.
MDR and IVDR Under Review in the European Union
European Union regulatory authorities have introduced initial proposals to revise MDR and IVDR (Medical Device Regulation and In Vitro Diagnostic Regulation).
The objective is to adjust regulatory operations to reduce challenges faced by manufacturers during certification and maintenance processes.
Discussions include improvements in regulatory predictability and possible timeline extensions in specific situations. They also address requirement adjustments affecting product availability in the European market.
Since their implementation, MDR and IVDR have significantly increased technical and documentation requirements for manufacturers, strengthening safety and performance standards.
However, this framework has introduced challenges, including rising regulatory costs, process complexity, and limited notified body capacity.
Basically, the proposed revisions aim to improve regulatory efficiency without compromising core objectives.
For manufacturers, changes to MDR and IVDR may affect regulatory planning, market priorities, and product lifecycle timelines.
This is a topic expected to remain highly relevant in the coming months.
QMSR comes into Force in the United States
The FDA’s new Quality Management System Regulation (QMSR) has entered into force, aligning medical device quality system requirements with ISO 13485.
The update represents an important step toward international regulatory harmonization.
In practice, it introduces relevant adjustments to compliance expectations for manufacturers operating in the U.S. market, requiring updates to internal procedures, documentation, and audit processes.
China Launches Plan to Strengthen Quality Systems in the Cosmetics Industry
Chinese regulatory authorities announced a 2026–2028 action plan aimed at strengthening quality systems for cosmetics manufacturers.
The initiative includes enhanced risk-based supervision, stronger raw-material control, and continuous compliance monitoring throughout the product lifecycle.
Certainly, this signals a clear increase in regulatory expectations for companies manufacturing or exporting to the Chinese market.
FDA Publishes Draft Guidance for Cosmetics
The FDA has released a draft guidance outlining updated safety and regulatory expectations applicable to cosmetic products.
The document reinforces the need for robust technical documentation, proper recordkeeping, and strengthened post-market monitoring practices.
Although still preliminary, the guidance indicates the future regulatory direction and allows companies to begin early adjustments to their compliance processes.
Quality, Traceability, and Regulatory Oversight
Discussions surrounding MDR and IVDR, combined with the implementation of QMSR in the United States and new regulatory initiatives in China and the U.S. cosmetics sector, demonstrate that the global regulatory environment continues to move toward stronger models of quality, traceability, and oversight.
For manufacturers and internationally active companies, monitoring these changes and integrating regulatory intelligence into business strategy is essential to reduce risks, maintain compliance, and sustain competitiveness in increasingly demanding markets.
Whether the topic is MDR and IVDR, cosmetics regulatory trends, or new publications from regulatory authorities, the Sobel newsletter is where you will find the most important industry updates.
Subscribe to the Sobel News Round Up for free and stay informed about developments that may impact your company across the medical devices, IVD, and cosmetics sectors.
Building a successful regulatory strategy requires staying prepared for ongoing global regulatory updates.
