EU MDR Compliance Timeline 2024–2028: Key Deadlines, Delays, and Compliance

By Dr. Samundeeswari Balasekaran | AptSkill – Advancing MedTech, One Course at a Time

The EU Medical Device Regulation (EU MDR 2017/745) has fundamentally reshaped the regulatory landscape for medical devices in Europe. With its focus on enhancing safety, transparency, and clinical evidence standards, staying compliant with EU MDR is no longer optional—it's essential.

But as the regulatory framework continues to evolve, so does the EU MDR compliance timeline. Delays in EUDAMED, new transition periods, and shifting deadlines mean that manufacturers must remain vigilant, adaptive, and proactive.

This guide breaks down the EU MDR deadlines and updates for 2024–2028 into actionable insights, so you can stay ahead of the curve.

📅 EU MDR Compliance Timeline: What’s Already Implemented

✅ Full Application of MDR (May 26, 2021)

• The MDR framework became mandatory for all new medical devices placed on the EU market.

• Class I self-certified devices must comply.

• Legacy devices (with valid MDD/AIMDD certificates) can continue under Article 120(3) conditions.
  
  

✅ Regulation (EU) 2023/607 (March 20, 2023)

• Extended transition periods based on device risk class.

• Eliminated the sell-off period: Devices placed on the market under MDD/AIMDD can remain available indefinitely (subject to conditions).
  
  

✅ QMS and Notified Body Application Deadline (May 26, 2024)

• Manufacturers of legacy devices must have a Quality Management System (QMS) aligned with MDR Article 10(9).

• Notified Body applications for MDR certification must have been submitted.

• Custom-made Class III devices must also have applications submitted.

🔍 What’s Yet to Be Implemented

📌 Notified Body Agreement Deadline (September 26, 2024)

To benefit from transition timelines, manufacturers must have a signed agreement with a Notified Body by this date. Missing this deadline means losing access to extended transition periods.

📌 Supply Disruption Notification Requirement (January 10, 2025)

Manufacturers must provide at least six months’ notice for anticipated supply disruptions of critical devices.

📌 Phased EUDAMED Roll-Out (January 1, 2026)

Mandatory use of EUDAMED modules for:

• Actor registration

• UDI and device registration

• Certificates and Notified Body data

• Market surveillance and vigilance reporting

📌 Custom-Made Class III Devices Compliance (May 26, 2026)

All custom-made Class III devices must be fully compliant with MDR requirements to remain on the market.

📌 End of Transition Period for High-Risk Devices (December 31, 2027)

All Class III and most implantable Class IIb devices must hold MDR certification by this date.

📌 Final MDR Transition Deadline (December 31, 2028)

All remaining legacy certificates for Class IIa, IIb, and reclassified Class I devices will expire.

⏳ What’s Delayed

📌 EUDAMED Full Implementation

The European Commission initially targeted a fully functional EUDAMED by 2022. However, due to IT development delays, full operationalization is now expected by 2026, with phased roll-outs starting earlier.

📌 Regulation (EU) 2024/1860 (Proposed)

This proposal introduces:

• Further transition extensions for certain IVDR devices.

• Mandatory supply disruption notifications.

• Phased EUDAMED implementation.

While adoption is expected in 2024, this regulation is not yet legally binding as of May 2024.

💡 Key MDR Compliance Tips for Medical Device Manufacturers

✅ Act Early—Don’t Wait for Final Deadlines
Proactive manufacturers are already aligning QMS and clinical evidence with MDR standards. Delays in Notified Body availability mean early application is critical.

✅ Secure a Notified Body Agreement Before September 2024
No agreement? No transition benefit. This is a non-negotiable deadline.

✅ Monitor EU MDR Updates Regularly
Stay informed on European Commission publications, MDCG guidance, and evolving requirements. Regulatory landscapes change fast—don’t be caught off guard.

✅ Invest in Digital Tools for EUDAMED Compliance
Prepare systems for UDI, actor registration, certificate uploads, and vigilance reporting. EUDAMED compliance is mandatory by 2026—future-proof your operations now.

✅ Strengthen Clinical Evidence Now
The bar for clinical data under MDR is high. Conduct gap analyses, PMCF studies, and risk-benefit justifications—especially for Class IIb and III devices.

✅ Plan for Supply Disruption Notifications
Anticipate supply chain risks and establish internal processes for 6-month advance notifications starting January 2025.

🔗 Final Thoughts: Stay Ahead in the EU MDR Compliance Journey

The EU MDR is not static—it’s a living, evolving regulation. While delays in EUDAMED and new proposals like Regulation (EU) 2024/1860 offer some breathing room, ultimate deadlines remain firm. Staying ahead means:

✅ Understanding the evolving EU MDR timeline
✅ Securing Notified Body agreements before critical deadlines
✅ Building a culture of regulatory agility and compliance

At AptSkill, we’re here to help you navigate the complexities of EU MDR compliance—from training your teams to preparing robust QMS documentation and ensuring readiness for Notified Body audits.

Don’t wait—contact us today to ensure your organization stays MDR-ready!

📌 Stay Informed

For the latest EU MDR updates, visit:
🔗 European Commission Medical Devices

📚 References

• European Commission. (2023, March 20). Regulation (EU) 2023/607 of the European Parliament and of the Council. Link

• European Commission. (2017, May 5). Regulation (EU) 2017/745. Link

• European Commission. (n.d.). Medical Devices: New Regulations. Link

• European Commission. (2024, January 23). Proposal for a Regulation (EU) 2024/1860. Link

📣 Need help with EU MDR compliance?

Get in touch with AptSkill for expert guidance, training, and support on navigating the complex world of EU medical device regulation.

🌐 Visit us at www.aptskill.in
📧 Email: info@aptskill.in
📞 Call/WhatsApp: +91-8262083746