EU MDR Amendments Summary
Source: EUR-Lex: EU MDR 2017/745 | Data Layer: amendments.json
Amendments Overview
| Amendment | OJ Reference | Effective Date | Core Changes |
|---|---|---|---|
| 2020/561 | OJ L 130, 24.4.2020 | 2020-04-24 | Transition Extension (COVID-19) |
| 2023/607 | OJ L 80, 20.3.2023 | 2023-03-20 | Transition Extension (Legacy Devices) |
| 2024/1860 | OJ L, 2024/1860, 9.7.2024 | 2024-07-09 | Gradual EUDAMED roll-out + Supply interruption notification + IVDR transition extension |
Amendment 2020/561
Regulation Number: Regulation (EU) 2020/561
OJ Reference: OJ L 130, 24.4.2020, p. 18–22
Effective Date: 2020-04-24
EUR-Lex: CELEX:32020R0561
Background
In early 2020, the COVID-19 pandemic prevented the medical device industry from completing MDR compliance preparations as originally planned. The European Commission proposed to postpone the application date of the MDR by one year.
Key Changes
MDR Application Date Postponement:
- Original application date: 26 May 2020
- New application date: 26 May 2021
Transition Arrangements:
- The validity of certificates issued under MDD/AIMDD was extended to 26 May 2024 (originally 26 May 2023).
- Provided manufacturers with additional time to achieve MDR compliance.
Impact
This amendment was an emergency response to the COVID-19 pandemic, ensuring that the medical device supply chain was not disrupted due to the regulatory switch.
Amendment 2023/607
Regulation Number: Regulation (EU) 2023/607
OJ Reference: OJ L 80, 20.3.2023, p. 24–28
Effective Date: 2023-03-20
EUR-Lex: CELEX:32023R0607
Background
After the MDR became applicable, due to insufficient notified body capacity and lagging manufacturer compliance progress, a large number of legacy devices faced the dilemma of expiring certificates without approved MDR certificates, which could have led to device shortages on the market.
Key Changes
Extension of Transition Period for Legacy Devices (Amending Article 120):
| Device Class | Original Deadline | New Deadline |
|---|---|---|
| Class III and implantable Class IIb | 2024-05-26 | 2027-12-31 |
| Other Class IIb, Class IIa, Class I (sterile/measuring/reusable surgical) | 2024-05-26 | 2028-12-31 |
Conditions for Application (Must meet all):
- The device must have obtained a CE mark under MDD/AIMDD before 26 May 2021.
- The design and intended purpose of the device have not undergone significant changes.
- The manufacturer must have submitted an application for MDR conformity assessment to a notified body before 26 May 2024.
- The device continues to comply with MDD/AIMDD requirements.
New Requirements:
- Manufacturers must register in EUDAMED (once fully functional).
- Must continually fulfill post-market surveillance obligations.
- Must report serious incidents to competent authorities.
Impact
This amendment provided a longer transition period for legacy devices, preventing the risk of large-scale supply disruptions in the medical device market, while simultaneously demanding manufacturers to actively advance their MDR compliance efforts.
Amendment 2024/1860
Regulation Number: Regulation (EU) 2024/1860
OJ Reference: OJ L, 2024/1860, 9.7.2024
Effective Date: 2024-07-09 (Art.1(1) and Art.2(1) applicable from 2025-01-10)
EUR-Lex: CELEX:32024R1860
Background
2024/1860 is a comprehensive amendment that simultaneously amends both the MDR (2017/745) and IVDR (2017/746) to address three core issues:
- The gradual roll-out arrangement of the EUDAMED database.
- Prevention and notification mechanisms for medical device supply interruptions.
- Extension of the transition period for specific IVDR device classes.
Key Changes
1. Gradual Roll-out of EUDAMED (Amending MDR Art.34 and IVDR Art.30)
EUDAMED will no longer require a one-time full launch. Instead, functional modules will be gradually rolled out:
| EUDAMED Module | Roll-out Arrangement |
|---|---|
| Economic Operators Registration | Gradual mandatory |
| UDI Database | Gradual mandatory |
| Device Registration | Gradual mandatory |
| Notified Bodies and Certificates | Gradual mandatory |
| Clinical Investigations / Performance Studies | Gradual mandatory |
| Vigilance | Gradual mandatory |
| Market Surveillance | Gradual mandatory |
The European Commission will determine the specific launch dates for each module through implementing regulations.
2. New Article 10a — Notification of Interruption of Supply (MDR)
New Obligation: Manufacturers must notify competent authorities 6 months (for life-sustaining or life-supporting devices) or 3 months (for other devices) prior to an anticipated interruption or discontinuation of supply.
Notification must include:
- Reasons for the interruption/discontinuation of supply.
- Anticipated date of interruption.
- List of affected devices.
- Possible alternatives.
Scope of Application:
- Devices marketed within the EU.
- The interruption could have a significant impact on patient health.
3. IVDR Transition Extension (Amending IVDR Art.110)
| IVDR Device Class | Original Deadline | New Deadline |
|---|---|---|
| Class D (high-risk IVD) | 2025-05-26 | Unchanged |
| Class C | 2026-05-26 | Unchanged |
| Class B | 2027-05-26 | Unchanged |
| Class A (sterile) | 2027-05-26 | Unchanged |
| Class A (non-sterile) | 2027-05-26 | 2030-12-31 |
| Specific Devices (new Art.110(3a)) | — | 2028-05-26 → 2030-12-31 |
Important: 2024/1860 extends the transition deadline for specific IVDR devices (primarily Class A non-sterile IVDs) from 2028-05-26 to 2030-12-31.
Dates of Application
- Art.1(1) (MDR amendment): Applicable from 10 January 2025.
- Art.2(1) (IVDR amendment): Applicable from 10 January 2025.
- Other provisions: Applicable from 9 July 2024.
Amendment Timeline
2017-05-05 EU MDR 2017/745 published (OJ L 117)
2017-05-25 MDR entered into force (20th day following publication)
2020-04-24 Amendment 2020/561: MDR application date postponed to 2021-05-26
2021-05-26 EU MDR fully applicable
2023-03-20 Amendment 2023/607: Transition for legacy devices extended to end of 2027/2028
2024-07-09 Amendment 2024/1860: EUDAMED gradual roll-out + Supply interruption notification + IVDR extension
2025-01-10 2024/1860 Art.1(1) and Art.2(1) become applicable
2027-12-31 Transition deadline for legacy Class III and implantable Class IIb devices
2028-12-31 Transition deadline for other legacy devices
2030-12-31 Transition deadline for IVDR Class A non-sterile devicesRelated Pages
- EU MDR 2017/745 Overview
- Article 10 — General Obligations of Manufacturers
- Article 52 — Conformity Assessment Procedures
- Annex I — GSPR