EU MDR Article 120 Legacy Devices: What You Must Do Before Deadline

What Article 120 Actually Says

Article 120 of the EU Medical Device Regulation (EU) 2017/745 provides transitional provisions for devices that were lawfully placed on the EU market under the previous directives — MDD (93/42/EEC) and AIMDD (90/385/EEC). It is the legal mechanism that allowed legacy devices to continue circulating in the EU market while manufacturers worked toward full MDR compliance.

The original Article 120 framework allowed devices with valid MDD/AIMDD certificates to continue on the market until those certificates expired, with a final backstop date. However, following supply chain concerns raised during the COVID-19 pandemic and persistent capacity constraints among Notified Bodies, the EU enacted Regulation (EU) 2023/607 in March 2023, which significantly extended the transitional dates and added new conditions.

Understanding what Article 120 requires is not optional for any manufacturer still operating under MDD/AIMDD certificates. The window is closing, and the requirements for remaining compliant during the transition period are more demanding than many manufacturers realize.

The Revised Transition Deadlines Under Regulation 2023/607

Regulation (EU) 2023/607 established new Article 120 transition dates based on device risk class. The revised deadlines are:

Class III and implantable Class IIb devices: December 31, 2027. This is the hard deadline for these highest-risk legacy devices to have a valid MDR certificate from a Notified Body, or to cease EU market activity.

Class IIa, non-implantable Class IIb, and Class I devices requiring Notified Body involvement: December 31, 2028.

Class I devices that do not require Notified Body involvement under MDR: These devices fall outside the Article 120 transitional framework entirely — if a Class I device under MDD becomes Class I under MDR with no Notified Body involvement, it can self-certify under MDR at any time.

These deadlines are hard cutoffs. A device without a valid MDR certificate after its applicable deadline cannot be legally placed on the EU market, and existing stock already in the supply chain can only be distributed until the date permitted under the MDD/AIMDD certificate.

Critical condition added by 2023/607: To benefit from the extended deadlines, manufacturers must have had a valid MDD/AIMDD certificate as of May 26, 2021, AND must have entered into a written agreement with a Notified Body for MDR conformity assessment by September 26, 2024. If you missed that Notified Body agreement deadline, the extended dates do not apply to your devices.

QMS Requirements During the Transition Period

One of the most commonly misunderstood aspects of Article 120 is that operating under the transitional provisions is not a compliance holiday. Manufacturers relying on Article 120 must meet specific ongoing obligations to maintain eligibility for the transitional period.

QMS under MDR standards: Even while your device certificate remains under MDD, your QMS must be compliant with the MDR quality system requirements (Article 10(9) and Annex IX, Chapter I). This is a significant distinction from simply continuing under your ISO 13485 certification — MDR Article 10 adds requirements that go beyond ISO 13485, including post-market surveillance requirements, vigilance reporting, and EUDAMED registration obligations.

EUDAMED registration: All manufacturers must register in EUDAMED and maintain device registration data, even during the transitional period. Economic operator registration became mandatory in EUDAMED as the database modules became available. Failure to register is an infringement regardless of the transitional certificate status.

Post-market surveillance: MDR Article 10(9) requires that post-market surveillance systems be in place and functioning from the MDR application date. Legacy device manufacturers cannot defer PMS system implementation to the date their MDR certificate is granted — it must be in place now.

Serious incident reporting: Vigilance reporting obligations under MDR Articles 87-90 apply immediately to all manufacturers, including those operating under Article 120 transitional provisions. MDD vigilance reporting procedures do not satisfy MDR requirements.

Technical Documentation Requirements for MDR Transition

The single largest workload item for most legacy device transitions is bringing technical documentation into MDR compliance. MDR Annex II and Annex III define the required content of technical documentation, and the delta from MDD Technical Files is substantial.

Clinical evaluation: MDR requires a clinical evaluation conducted in accordance with Article 61 and Annex XIV. The equivalence pathway that many MDD manufacturers relied upon is significantly restricted under MDR — claiming equivalence to a competitor device is no longer straightforward and, for Class III devices and some implantable devices, requires a formal contractual arrangement with the predicate device manufacturer.

Summary of Safety and Clinical Performance (SSCP): Class III and implantable devices require an SSCP (Article 32) that must be registered in EUDAMED and made publicly available. This document summarizes the device's safety and performance data and clinical evidence, and must be updated annually or when significant new information becomes available.

Risk management: ISO 14971:2019 is the current version required. If your risk management files were built against ISO 14971:2007, they need to be updated — the 2019 version introduced changes to risk acceptability criteria and removed the concept of ALARP for medical devices (risks must be reduced as far as possible, not merely to ALARP).

Labeling: MDR Annex I Section 23 and Regulation (EU) 2017/745 Article 10(11) require specific labeling elements including the UDI (unique device identifier), EUDAMED reference, and specific symbol standards. Labeling changes often require new packaging runs, which take time and budget to implement.

If You Have Not Started: Immediate Action Plan

If your organization has not yet contracted with an EU Notified Body for MDR conformity assessment, your situation is serious. The September 26, 2024 deadline for establishing a Notified Body agreement to benefit from the extended transition dates has passed. This means you are operating on the original transitional timeline, which may already have expired for your device class.

Step 1: Audit your current certificate status. For each device on the EU market, identify: the certificate expiry date, the device class under MDR (which may differ from MDD class), and whether a Notified Body agreement was in place before September 26, 2024.

Step 2: Determine which devices are viable for MDR transition. Not every device in your portfolio will be economically viable to pursue through MDR. Some legacy products with limited EU revenue may be better withdrawn from the EU market rather than investing in full MDR compliance. Make explicit portfolio decisions now.

Step 3: Prioritize your Notified Body application. Notified Body capacity remains constrained. Queue times for initial MDR audits can run 12-18 months from application. Even if you are within the transitional window, time is short.

Step 4: Build your MDR technical documentation gap analysis. Compare your current technical file against MDR Annex II requirements. The clinical evaluation and risk management gaps are almost always the longest-lead items to remediate.