EU MDR Update: What the Latest Extensions Mean for US Companies

The European Medical Device Regulation (EU MDR) has been a moving target since its initial 2017 adoption. The latest round of deadline extensions, announced in late 2024, provides some relief—but US medical device companies still face significant decisions about their European market strategy.

What Changed

The European Commission has extended transition periods for certain legacy devices:

• Class III and implantable devices: Extended to December 2027 (from 2026)
• Class IIb devices: Extended to December 2028 (from 2027)
• Class IIa and Class I sterile/measuring: Extended to December 2028 (from 2027)

These extensions apply to devices that had valid CE certificates under the previous directive (MDD) and have initiated the MDR conformity assessment process.

What Hasn't Changed

Several key requirements remain unchanged:

• New devices still require MDR certification before market access
• Significant changes to existing devices trigger MDR requirements
• Post-market surveillance and vigilance requirements are fully in force
• Economic operator and UDI requirements apply regardless of certification status

Implications for US Companies

Companies with Existing CE Marks

If you have MDD certificates for devices in the European market, the extensions provide breathing room—but not a pass. You should:

• Confirm your Notified Body can support your timeline
• Assess whether planned product changes will trigger full MDR certification
• Continue building clinical evidence required for MDR submissions
• Maintain compliance with current post-market requirements

Companies Planning European Entry

For US companies not yet in Europe, the calculation is different:

• There's no "easier" legacy pathway—new entrants face full MDR requirements
• Notified Body capacity remains constrained
• Clinical evidence expectations are higher than under MDD
• The economic case for European entry should be reassessed given increased costs

Strategic Considerations

Several strategic questions merit consideration:

• Market sizing: Is the European market large enough to justify MDR investment?
• Competitive timing: Will competitors use MDR complexity as a barrier to entry?
• Clinical data strategy: Can European clinical requirements be aligned with US needs?
• Partnership options: Would a European distribution partner be more efficient than direct market entry?

The Bottom Line

The MDR extensions are welcome but don't change the fundamental reality: European market access for medical devices is more complex and expensive than ever before. US companies should make deliberate decisions about their European strategy based on realistic assessment of costs, timelines, and market opportunity.