MDCG Manual on Borderline and Classification (Version 4)

Borderline products remain one of the trickiest challenges under the EU Medical Device Regulation (EU) MDR 2017/745 and the In Vitro Diagnostic Regulation (EU) IVDR 2017/746. Determining whether a product qualifies as a medical device, and if so, how it should be classified, has enormous implications for compliance, market access, and time to market.

That’s why the Medical Device Coordination Group (MDCG) publishes the Manual on Borderline and Classification, a practical reference to help align interpretation across the EU.  In September 2025, the MDCG released Version 4 of this manual, providing new examples, clarification, and updates that manufacturers cannot afford to ignore.

So, what’s changed, and what does this mean for medical device organizations?

EU MDR 2017/745 and the Role of the MDCG Manual

The EU MDR and EU IVDR were designed to strengthen safety and performance standards for medical devices and in vitro diagnostics placed on the European market.  But the transition has not been simple, and borderline cases often test the limits of the regulations’ definitions.

That’s where the MDCG Manual on Borderline and Classification comes in.  It is not legally binding, but it’s highly influential in how Competent Authorities and Notified Bodies interpret the rules.  By providing detailed case examples, the manual aims to harmonize decisions across Europe, giving manufacturers more predictability.

The manual helps answer critical questions such as: Does this wellness app count as Software as a Medical Device (SaMD)? and How should drug-device combination products be classified?

For Manufacturers, the manual is a go-to resource when navigating borderline determinations that could make or break a regulatory strategy.

What’s New in Version 4 (September 2025)

The Version 4 update of the MDCG Manual introduces several important changes compared with Version 3.  The key highlights include new product categories with examples now covering emerging areas like digital health and wellness technologies, reflecting the growing overlap between consumer products and regulated devices.  Software as a Medical Device (SaMD) is expanded to help clarify the distinction between general wellness apps and application intended for diagnosis, monitoring, or treatment.  For drug-device combinations, additional examples refine the criteria for when MDR vs. medicinal product legislation takes precedence.  Aesthetic products also have updated notes on products with cosmetic purposes but potential physiological impact, e.g., dermal fillers and laser devices.  In relation to consistency with case law, adjustments now align the guidance with recent rulings and notified body experience.

It’s clear that this is not just a minor refresh.  Version 4 acknowledges the fast pace of innovation and ensures the manual reflects today’s product landscape.

Key Changes Compared to Previous Versions

While earlier editions provided a baseline, Version 4 goes further in tightening and clarifying borderline classifications.  Compared with Version 3, we see an expansion of scope with more product types now explicitly falling under MDR or IVDR, and stricter interpretation where devices that previously may have sat outside the framework are now pulled firmly within MDR scope.  Finally, some outdated scenarios have been removed, while others have been refined to avoid ambiguity.

The overall effect? More products will require medical device CE marking and oversight by a notified body, even if previously marketed as general wellness or consumer items.

For manufacturers who assumed their product was “out of scope”, this could represent a major shift in regulatory obligations.

What This Means for Manufacturers

For medical device organizations, Version 4 of the MDCG Manual is more than just an update.  It is a call to action.

Manufacturers should look at their product portfolio and conduct an immediate review of all borderline or borderline adjacent products to check whether Version 4 changes the classification status or pushes products into MDR scope.

If an organization’s product now qualifies as a medical device, organizations should prepare or update their technical files in line with MDR requirements, including clinical evaluation, risk management, and post-market surveillance plans.  Products moving into higher risk classes may require additional clinical data.  This could affect development timelines and market strategy.

Early engagement with Notified Bodies is critical to avoid delays.  Don’t assume a borderline determination will be straightforward.  Regulators are looking closely at these areas.  Waiting until the next conformity assessment could put organizations at risk of non-compliance or even market withdrawal.  Proactive reassessment is the safest route.

Conclusion

The release of the MDCG Manual on Borderline and Classification, Version 4 (September 2025) is another reminder that the (EU) MDR 2017/745 and (EU) IVDR 2017/746 continue to evolve.  For manufacturers, this means staying agile, reassessing assumptions, and building regulatory strategy around the latest guidance.

It seems that Version 4 is a step forward bringing greater clarity, especially in areas like digital health, software, and drug-device combinations.  But it also raises the bar.  More products will fall under MDR scope, and compliance expectations are rising.  For organizations, the message is clear, don’t wait.  Review portfolio’s now, align with the new guidance, and get ahead of potential regulatory hurdles.

Navigating MDR borderline decisions is complex, but with the right strategy, it is manageable.