---
title: The MDR Amendment (EU) 2023/607: Extended Transition Periods for Legacy Devices
description: Complete breakdown of the MDR amendment (EU) 2023/607 that extended transition periods for legacy medical devices. Learn what changed, new deadlines, and what it means for your MedTech startup.
authors: Tibor Zechmeister, Felix Lenhard
category: MDR Fundamentals & Regulatory Strategy
primary_keyword: 
canonical_url: https://zechmeister-solutions.com/en/blog/mdr-amendment-2023-607-extended-transition-periods
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# The MDR Amendment (EU) 2023/607: Extended Transition Periods for Legacy Devices

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

If you have been anywhere near the MedTech regulatory space since 2023, you have heard the phrase "extended transition" thrown around in every webinar, conference hallway, and LinkedIn thread. But what exactly changed? What does Regulation (EU) 2023/607 actually say? And more importantly — what does it mean for your startup right now?

Let me be honest: the original MDR transition timeline was a slow-motion collision. The regulation demanded that every single medical device on the EU market be re-certified under the new rules by May 2024. The Notified Bodies did not have the capacity. The manufacturers did not have the documentation. The system was heading toward a cliff where thousands of safe, proven devices would lose their CE mark overnight — not because they were dangerous, but because the paperwork pipeline could not keep up.

The EU Commission recognized this. Regulation (EU) 2023/607, adopted on 20 March 2023, was the legislative response.

## What the Amendment Actually Changed

The core change is straightforward: (EU) 2023/607 amended Article 120 of the MDR (Regulation (EU) 2017/745) to extend the transition periods for devices that still held valid certificates or declarations of conformity under the old Medical Device Directives (MDD 93/42/EEC and AIMDD 90/385/EEC).

Before the amendment, Article 120(2) set a hard deadline: devices covered by certificates issued under the old directives could remain on the market only until 26 May 2024. After that date, no MDD certificate — no market.

The amendment replaced that single cliff-edge deadline with a staggered timeline based on device risk class:

**For higher-risk devices (Class III and Class IIb implantable devices):**
The deadline was extended to **26 May 2027**. 

**For lower-risk devices (Class IIb non-implantable, Class IIa, and Class I devices requiring Notified Body involvement):**
The deadline was extended to **26 May 2028**. 

This staggered approach was deliberate. Higher-risk devices were given less time because they are the priority — Notified Bodies should process the most critical devices first. Lower-risk devices got an additional year because the regulatory risk of keeping a well-established Class IIa product on the market under its old certification is lower than for a Class III implant.

## The Conditions You Must Meet

Here is where startups get tripped up. The extended deadlines are not a free pass. They come with explicit conditions that your device must meet continuously. If you fail any of these conditions, the extension does not apply and your device loses its right to be on the market.

**Condition 1: The device must continue to comply with the old directives.**
Your MDD or AIMDD compliance does not freeze in amber. You must maintain ongoing compliance with the directive under which your device was originally certified. Your quality management system must remain functional. Your technical documentation must stay current. 

**Condition 2: No significant changes to the design or intended purpose.**
If you make a significant change to your device's design or intended purpose, the old certificate no longer covers it. A significant change triggers a new conformity assessment — under MDR, not MDD. This is a critical trap for startups that want to iterate on their product during the transition period. 

**Condition 3: The device must not present an unacceptable risk to health and safety.**
This is the market surveillance backstop. If a competent authority determines your device poses an unacceptable risk, the transition period protection evaporates regardless of deadlines.

**Condition 4: You must have applied to a Notified Body for MDR conformity assessment by a specific date.**
This is the one that catches people. The amendment requires that manufacturers have submitted an application to a Notified Body for MDR certification. The intent is clear: the extended timeline is for manufacturers who are actively working toward MDR compliance, not for those who are using the extension as an excuse to do nothing. 

**Condition 5: A written agreement or signed contract with a Notified Body must exist by a specific date.**
Beyond just applying, you need evidence of an actual engagement with a Notified Body. 

## What "Legacy Device" Actually Means

The amendment introduced the concept of a "legacy device" more formally into the MDR framework. Understanding this term is critical because it determines whether your device qualifies for the extended transition at all.

A legacy device, in this context, is a device that was lawfully placed on the market under MDD or AIMDD before the MDR application date (26 May 2021) and continues to be placed on the market after that date under the transitional provisions.

For startups, this creates a sharp divide:

**If your device already had a valid MDD/AIMDD certificate or declaration of conformity before 26 May 2021:** You are potentially covered by the transition provisions, assuming you meet all the conditions above.

**If your device is entirely new and never had MDD/AIMDD certification:** The transition provisions do not apply to you. You must go directly to MDR. No extended deadlines. No grace period. Full MDR conformity assessment from day one.

This is a point Tibor makes repeatedly to the startups he works with: "If you are building something new, the transition is irrelevant to you. You are an MDR-native company. That is actually an advantage — you do not carry the technical debt of MDD documentation that needs to be upgraded. You build it right from the start."

## The "Sell-Off" Period

The amendment also addressed what happens to devices already in the supply chain when the transition deadlines hit. Article 120(4) was amended to provide that devices placed on the market during the transition period may continue to be made available on the market or put into service until **26 May 2029**. 

This "sell-off" provision is important for distribution chains. If a distributor holds stock of a device that was lawfully placed on the market before the manufacturer's transition deadline expired, that stock can continue to be sold. The sell-off period provides a buffer so that compliant products already in warehouses and on hospital shelves do not become illegal overnight.

For startups, this matters if you are distributing through channel partners. Your distributors need to understand these timelines and plan their inventory accordingly.

## Why the Amendment Happened — The Capacity Problem

To understand the amendment properly, you need to understand why it was necessary. And the answer is brutally simple: the system could not handle the workload.

When MDR was adopted in 2017, the EU had approximately 50 Notified Bodies under MDD. By the time MDR applied in 2021, only a fraction had been designated under MDR. The bottleneck was severe. Thousands of manufacturers needed new certifications, and the designated Notified Bodies simply could not process them all in time.

Tibor has seen this from the inside — both as a Notified Body lead auditor and as someone guiding companies through the process: "The capacity problem was predictable from 2017. Anyone who looked at the numbers could see that the timeline was unrealistic. But the political process moves slowly. It took the very real threat of device shortages — patients not getting the devices they need — to force the legislative correction."

The amendment was not a sign of regulatory weakness. It was a pragmatic acknowledgment that patient safety is served not only by rigorous regulation but also by keeping safe, effective devices available. Pulling thousands of devices off the market because of a paperwork backlog would have harmed the very patients MDR is designed to protect.

## What This Means for Startups — Practical Implications

### If You Are a New Startup Building a New Device

The transition provisions are largely irrelevant to you, but you need to understand them for two reasons:

1. **Notified Body capacity is still constrained.** The transition workload competes with new applications for Notified Body attention. If you are applying for MDR certification as a new manufacturer, you are in the same queue as legacy manufacturers transitioning from MDD. Plan your timelines accordingly — build in buffer for Notified Body delays.

2. **Your competitors may be operating under transition provisions.** Understanding the landscape helps you plan your competitive strategy. A competitor selling under an MDD certificate has different constraints and timelines than you do.

### If You Acquired or Are Working with a Legacy Product

If your startup has acquired a legacy product or a portfolio that includes MDD-certified devices, the amendment is directly relevant:

1. **Map every device to its risk class and corresponding deadline.** Do not treat this as a generic "we have more time" situation. The staggered deadlines mean different products in your portfolio may have different expiration dates.

2. **Verify that all conditions are continuously met.** Missing even one condition voids the protection. Set up monitoring to ensure ongoing compliance with the old directives, track any design changes, and maintain your Notified Body relationship.

3. **Get your Notified Body application in if you have not already.** The application and contract deadlines are hard gates. If you missed them, consult legal counsel immediately.

### Regardless of Your Situation

**Do not treat the extended timeline as extra time to procrastinate.** This is the single most important takeaway. The amendment gave the industry breathing room, not a vacation. The companies that use this time wisely — building robust MDR-compliant quality management systems, preparing thorough technical documentation, engaging proactively with Notified Bodies — will be in strong positions when the deadlines arrive. The companies that treat it as a reprieve will find themselves in exactly the same crisis in 2027 or 2028 that the industry faced in 2024.

## The Broader Context: MDR Is Not Going Away

Every time the EU extends a deadline or introduces an amendment, a certain faction of the MedTech industry starts hoping that MDR itself will be rolled back or fundamentally softened. Let me be direct: that is not going to happen.

The amendment (EU) 2023/607 was a logistical correction, not a philosophical retreat. The EU remains fully committed to the higher safety and performance standards that MDR establishes. The General Safety and Performance Requirements in Annex I have not changed. The clinical evidence requirements have not changed. The post-market surveillance obligations have not changed. The transparency requirements through EUDAMED have not changed.

What changed is the timeline for getting there. The destination is the same.

Tibor puts it bluntly: "I hear founders say, 'Maybe they will water down MDR.' They will not. The regulation exists because patients died from poorly regulated devices. The PIP breast implant scandal, the metal-on-metal hip failures — these are the reason MDR exists. The EU will adjust timelines, they will adjust processes, but they will not lower the safety bar. Build your company assuming full MDR compliance is the permanent reality, because it is."

## How to Use This Information

Here is your action list:

1. **Determine whether the transition provisions apply to any of your devices.** If you are purely new-to-market under MDR, they do not. Move on and focus on your MDR conformity assessment.

2. **If you have legacy devices, map each one to the correct deadline** based on its risk class under MDR classification rules (not MDD classification — the classes may differ).

3. **Verify all conditions are met and set up ongoing monitoring.** Assign someone on your team to own this. It is not a one-time check; it is continuous compliance.

4. **Build your MDR transition plan working backward from the deadline.** If your Class III device deadline is 2027, and your Notified Body estimates 12-18 months for conformity assessment, you needed to start yesterday. Do the math for your specific situation.

5. **Do not plan around further extensions.** Plan as if the current deadlines are final. If another extension comes, great — you are ahead of schedule. If it does not, you are not caught short.

## The Bottom Line

Regulation (EU) 2023/607 bought the MedTech industry time. It did not buy it a different destination. Every medical device sold in the EU will eventually need to fully comply with MDR. The amendment simply acknowledged that getting there takes longer than originally planned.

For startups, the key insight is this: whether you are building something new or working with legacy devices, MDR compliance is not optional and not temporary. The companies that treat the extended transition as an opportunity to build solid foundations — rather than an excuse to delay — will be the ones still standing when the music stops.

At the end of the day, this amendment is about one thing: making sure patients continue to have access to safe, effective medical devices while the industry completes the largest regulatory transition in MedTech history. That is a goal every startup should be aligned with.

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*This post is part of the [MDR Fundamentals & Regulatory Strategy](https://zechmeister-solutions.com/en/blog/category/mdr-fundamentals) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*