The global regulatory landscape continues to evolve, and 2026 is already beginning with clear signs of structural change across different regions. From debates around the impacts of the EU MDR IVDR on the medical device and in vitro diagnostics markets to new developments in the Asia-Pacific region, staying well informed has never been more important.
That’s why we’ve brought together the key regulatory movements shaping the sector. And explain why EU MDR and IVDR are key drivers transforming both European and global markets.
European Union study highlights EU MDR IVDR impacts on investment and innovation
A study commissioned by the European Union found that the regulatory requirements of the EU MDR IVDR are directly reshaping the structure of the medical device market across Europe.
According to the report, over half of companies reduced their portfolios, and many stopped manufacturing devices for the European market. The main reasons cited include high certification costs, regulatory complexity, and administrative burden.
Also, the study highlights growing skepticism about the current regulatory model’s ability to support technological innovation in coming years.
This occurs as the European Commission discusses simplifying regulations, signaling a potential adjustment phase in the regulatory governance model.
The EU MDR IVDR is now directly influencing business decisions, not only compliance processes.
Finally, the study provides a technical basis for evaluating possible reforms, showing the EU recognizes the structural impacts of these regulations.
United States: focus on chemical safety in the cosmetics sector
While EU MDR and IVDR dominate European debates, major regulatory developments are occurring across other global regions.
In the United States, a key development comes from a publication by the FDA — a MoCRA-mandated report on the presence of PFAS in cosmetic products.
Specifically, the document reinforces regulatory focus on chemical safety, ingredient transparency, and control of potentially harmful substances.
This movement increases regulatory pressure across supply chains, product formulation processes, and compliance strategies in the U.S. market.
Institutional integration to expand access to healthcare innovation in Brazil
In Brazil, Anvisa and ANS have initiated coordinated efforts to align strategies aimed at expanding public access to healthcare technologies.
The initiative integrates regulation, technology assessment, as well as public policy, signaling a more coordinated national regulatory ecosystem.
Asia-Pacific and regulatory harmonization in progress
In New Zealand, Medsafe has launched consultations and proposed updates to the regulatory model for medical devices, focusing on international alignment, process modernization, and strengthened regulatory governance.
This action is part of a broader trend of regulatory harmonization across the Asia-Pacific region.
Regulation as a growth strategy
The reality is that regulation is no longer just a technical requirement — it has become a strategic driver of growth, competitiveness, and international expansion.
EU MDR and IVDR now represent key forces reshaping the European medical device and IVD markets.
Beyond the EU MDR IVDR, across other regulated markets, companies that adopt a strategic regulatory approach are better positioned to anticipate change. And that makes a critical difference to long-term business success.
That’s why staying informed matters. Subscribe for free to the Sobel News Round Up and follow everything that can impact your company in the medical devices, IVDs, and cosmetics markets.
This way, you’ll be prepared for what the future holds across the world’s leading regulated markets.
