How the EU IVDR opens doors beyond the EU

In the European Union, the EU In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is written to set up a more robust system of conformity assessment that ensures the quality, safety, and performance of IVD medical devices placed on the EU market. It is designed to protect health for patients and users and guarantee smooth functioning of the market for these products. To achieve these objectives, the new regulations established a more harmonized, up-to-date, and robust framework. New and legacy device manufacturers seeking CE Marking under the IVDR will identify significant synergies to other international regulations, so that the benefits of IVDR compliance justify the regulatory work required for this update. As more markets align with the EU’s approach, the potential ROI of IVDR compliance increases.  

International quality management system compliance  

The costs of implementing an IVDR-compliant quality management system (QMS) (likely in accordance with the international standard ISO 13485) can be leveraged to enter the EU and other markets. Many markets accept or require ISO 13485 certificates or have drafted their own QMS requirements that are nearly identical to the standard. A well-known example is the revision of the US FDA Quality System Regulation (QSR, 21 CFR Part 820) into the Quality Management System Regulation (QMSR), which includes direct references to corresponding sections of ISO 13485. The QMSR will be effective February 2, 2026, and specific differences of QMSR need to be considered. Nevertheless, it will be much easier for medical device manufacturers to place devices on the EU and US markets.  

Leverage IVDR CE Marking for equivalency in other markets  

The MDR and the IVDR are directly applicable to all EU Member States, but CE Marking should facilitate smoother market entry into other markets, too. The CE mark can be sufficient to place medical devices on the market in Switzerland, the United Kingdom (until 30 June 2030), and Australia, as well as in many countries in Asia, Africa, the Middle East, and Latin America. Even if not completely accepted, CE Marking can streamline approval processes and accelerate time-to-market, as many elements like the updates to international standards (e.g., ISO 13485, ISO 15223-1, ISO 14971, IEC 62366-1, ISO 20916), classification system, UDI, application of product codes, labelling information etc. have been harmonized with international guidelines.  

In addition, CE Marking under IVDR is going to be the new standard. Legacy devices will gradually disappear from the market and soon may not be accepted in markets outside of the EU. Compliance with the IVDR can therefore bring significant advantages for entering new markets.  

Develop a global market access strategy  

Navigating regulatory compliance in any market is all about balancing business risks and business opportunities. How long does it take to enter the market (this may include sales activities through distributors and importers)? What do I need to do to comply with the legislation in this market and what will it cost? Who are my competitors? What are the growth opportunities and market dynamics?  

The process of gathering, analyzing, and interpreting regulatory intelligence related to regulatory requirements, changes, and trends that impact a specific industry, or organization is a crucial step that will help you answer these questions. Regulatory intelligence is relevant throughout your device's life cycle, as it helps you stay informed about changing regulations, reducing the risk of non-compliance, and identifying new market opportunities. Further, other elements such as pricing, reimbursement, logistics, or sales strategies may be important aspects to consider for your business.  

Pure Global assists manufacturers of IVD and medical devices to obtain EU CE Marking and global regulatory approvals in 32 international markets. From our 17 global offices, we also provide in-country representation services. If you have questions about regulatory pathways, classification, distributor search, country legislation requirements, competitor analysis, or go-to-market strategies, Pure Global can help. We will identify markets with the highest potential for your product portfolio. Contact us to learn more.