Medical Device Compliance: 2025 Insights & 2026 Priorities

As 2025 ends and 2026 begins, medical device and IVD manufacturers continue to navigate an increasingly complex global regulatory environment to maintain compliance.

Medical Device Developments of 2025 and What to Prioritize for 2026 

In this article, Daryl Wisdahl, Director of Consulting Services at MedEnvoy, reflects on the most impactful regulatory developments of 2025 and what manufacturers should prioritize as they plan for 2026. Featured on our Reg with Meg podcast, he addresses key questions related to regulatory pain points, shifting market dynamics, upcoming deadlines, and the strategic actions manufacturers should take now to remain compliant and competitive in the year ahead.

To view and listen to the full episode, see below:

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What Were the Most Impactful Medical Device Regulatory Changes in 2025? 

Several key regulatory developments for medical device and IVD manufacturers stood out in 2025. One of the most significant was the new EU regulation on artificial intelligence and how it applies to medical devices and IVD products, particularly those incorporating software or AI-driven functionality.

Progress around EUDAMED and Swissdamed also marked an important shift, changing how manufacturers approach device registration and data management across Europe and Switzerland. In parallel, continued updates and clarifications related to the MDR and IVDR further shaped expectations around implementation and enforcement, setting the stage for how these frameworks will evolve moving forward.

How Has the MDR and IVDR Landscape Evolved this Year?  

From an IVDR perspective, timelines continue to be a major challenge, particularly for Class B, C, and D devices. Many manufacturers are finding it difficult to complete all requirements within expected timeframes, especially as Notified Body availability becomes more limited.

On the MDR side, similar challenges persist. Manufacturers continue to struggle to move products through the certification process efficiently and at a manageable cost. As a result, lengthy review timelines and high costs are creating ongoing pressure, prompting some manufacturers to reconsider their EU market strategies. In some cases, companies are shifting focus to other markets where regulatory pathways are perceived as more predictable. 

What Should Manufacturers Prioritize as EUDAMED’s Electronic System Becomes Increasingly Important? 

As EUDAMED implementation timelines approach, manufacturers should first ensure their Basic UDI-DIs are properly established and aligned with MDR and IVDR requirements, as well as with the expectations of their Notified Bodies and Authorized Representatives.

It is also critical to update quality management system procedures to reflect EUDAMED-related requirements, including data maintenance, defined roles and responsibilities, and ongoing compliance activities.

Lastly, manufacturers should actively develop a secure process for uploading device data into EUDAMED to ensure they are operationally ready when it becomes mandatory in 2026.

What Actions Should Companies Take Now to Prepare for swissdamed? 

Manufacturers should work closely with their Swiss Authorized Representative (CH-Rep) to ensure all required company and device information is uploaded into Swissdamed.

One common misconception is that manufacturers can complete Swissdamed registration themselves without assistance from the CH-Rep. Unless a company is established in Switzerland, registration must be handled by a CH-Rep, making early communication with that partner essential. Since the CH-Rep is responsible for submitting this information, waiting until the deadline approaches could result in unavoidable delays.

How is the UK Regulatory Medical Device Compliance Framework Shifting for 2026? 

It is important that manufacturers have a clear understanding of the requirements for registration and device listing, which must be completed by the UK Responsible Person (UKRP). This is not optional. Every device intended for the UK market must be properly listed through the UKRP.

It is also important to understand the incident reporting requirements for the UK market, including how reportable events are submitted to the MHRA. Manufacturers need clear processes for how this reporting will be managed, as reporting can be completed either directly by the manufacturer or through the UKRP.

Manufacturers must also be aware of the deadlines and requirements related to the UKCA mark. Once the mark is applied to the device, the UKRP must be identified on the device labeling. This is a critical compliance point. Importers, however, do not currently need to be listed on the device labeling, but they are responsible for verifying that the UKRP is properly identified on devices bearing the UKCA mark. This means importers play a key role in compliance checks, even if their name is not on the label.

There is still some uncertainty as discussions about the UK’s long-term regulatory approach continue. Initially, the plan was to remove reliance on EU MDR CE marks and require UKCA compliance under revised UK regulations. However, those revised regulations have yet to be published, and there is still debate about whether manufacturers will be allowed to remain on the UK market by simply following EU MDR or IVDR compliance.

What New Labeling Requirements Should Manufacturers Pay Attention to in 2026 

Manufacturers should confirm full alignment with the EU’s UDI requirements, including UDI placement on labeling and, where applicable, directly on devices. While these requirements are already in effect for most high-risk medical devices, the remaining deadlines for lower-risk medical devices and IVDs are quickly approaching.

What US FDA Updates from 2025 Should Foreign Manufacturers Be Aware of for 2026?  

Foreign manufacturers should be aware that, effective February 22, 2026, the FDA will transition its Quality System Regulation by replacing 21 CFR Part 820 with ISO 13485–aligned requirements.

Manufacturers should also ensure they fully meet all applicable quality system requirements, whether they were previously compliant under Article 820 or are transitioning to ISO 13485 for the first time. As they plan for the year ahead, a strong focus on aligning quality management systems with ISO 13485 will be essential for continued compliance in the U.S. market.

What is One Strategic Priority to Stay Ahead of in 2026?

For medical device manufacturers who have not yet transitioned to the MDR, time is running out to achieve compliance. Delays at this stage significantly increase the risk of market disruption, making immediate action critical. In some cases, manufacturers may need to consider working with a different Notified Body if availability remains a limiting factor.

For IVD manufacturers, the priority should be to ensure that technical documentation is submitted for Notified Body review as soon as possible. With key deadlines approaching, early engagement is essential to avoid last-minute bottlenecks and compliance gaps.

Expert Insights from 2025 and Medical Device Compliance for 2026

This article highlights some of the key takeaways from MedEnvoy’s RegwithMEG podcast, where Daryl Wisdahl shares expert perspectives in 2025 regulatory changes and what manufacturers should be preparing for medical device compliance in 2026. To hear the complete conversation, listen to the full podcast episode, “Medical Device & IVD Regulations | 2025 Recap and 2026 Outlook.” If you have questions or need support with your regulatory strategy, contact MedEnvoy’s team of regulatory experts by clicking here, or learn more about our consulting services by clicking here.