Latest Change: 10. January 2025
The purpose of this article is to provide an overview of the current changes to the Medical Device Regulation (MDR). We collected all helpful data within the ColabON tool. This involved more than 100 hours of work. This includes the correlation to harmonized standards and the latest changes, ensuring you are ready to go.
Content:
Link to Consolidate Version of MDR
Released on April 2017
For CE marking and Market Access of Medical Devices
Change History der MDR Medical Device Regulation EU 2017/745
Version: Name Of Amendment: Content
10/01/2025: M6 Amendment: UDI of Contact Lenses
In Part C of Annex VI to Regulation (EU) 2017/745 the following sections are added: 6.6. Highly individualised devices
09/07/2024: M5 Amendment: Gradual roll-out of Eudamed
14/02/2024: M4 14.2.2024 Fees and charges payable to the European Medicines Agency
Changes to Article 106 Provision of scientific, technical and clinical opinions and advice
Paragraph 14.
Article 120 - Transitional provisions
Article 122 - Repeal
11/03/2023: M2 Amendment: Frequency of complete re-assessments of notified bodies Article 44, paragraph 10
24/04/2020: M1 Amendment: Change of Application Dates: 26 May 2020’ is replaced by ‘26 May 2021’
05/05/2017: Initale Version
The following Corrigendums and were are part of the initial File
C1 Corrigendum
C2 Corrigendum
MDR Change Summary 10/01/2025 UDI for Contact Lenses
Date of Effect: 09/11/2025
Source: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32023R2197
Actual Change: UDI for Contact Lenses
Article 1
In Part C of Annex VI to Regulation (EU) 2017/745 the following sections are added:
‘6.6. Highly individualised devices
6.6.1. Contact lenses
6.6.1.1. Standard contact lenses
A UDI-DI shall be assigned to standard contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (“Master UDI-DI”).
In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.
6.6.1.2. Made to order contact lenses
A UDI-DI shall be assigned to made to order contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (“Master UDI-DI”).
In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.’
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 9 November 2025.
However, manufacturers may already before that date assign a Master UDI-DI in accordance with Regulation (EU) 2017/745 as amended by this Regulation.This Text doesn't appear in the consolidated version of the yet.
All Changes of MDR Medical Device Regulation EU 2017/745
Why is the Enriched and Consolidated MDR Version helpful?
An MDR Consolidated Version is the ColabON tool used by manufacturers to ensure that all necessary requirements of the Medical Device Regulation (MDR) are being met.
This checklist includes:
The latest changes of the MDR
The MANUFACTURER Applicability and Traceability Statements
Includes the harmonization Text for the harmonised standards
Technical documentation requirements
GSPRs with General Safety and Performance Requirements with harmonisation texts.
Using an enriched and updated MDR helps manufacturers streamline their compliance efforts and avoid regulatory issues.
What is the MDR regulation in Europe?
The MDR regulation in Europe, formally known as Regulation (EU) 2017/745, governs the safety, performance, and marketing of medical devices in the European Union. It replaced the previous Medical Device Directive (MDD) and introduced stricter rules for clinical evaluations, post-market surveillance, and traceability of medical devices. The MDR applies to all medical devices sold in the EU, requiring manufacturers to meet stringent requirements to obtain CE marking for their products.
What is the difference between EU MDR and UK MDR?
The difference between EU MDR and UK MDR stems from regulatory divergence after Brexit. The EU MDR applies to medical devices marketed in the European Union, while the UK MDR governs medical devices in the United Kingdom. While the UK MDR currently mirrors many of the EU MDR's requirements, the UK has its own marking system (UKCA) and may implement different regulations over time as it develops independent standards.
What are the new requirements for the EU MDR?
The new requirements under the EU MDR include enhanced scrutiny of clinical evaluations, stricter post-market surveillance obligations, the implementation of Unique Device Identification (UDI) for traceability, and stricter requirements for high-risk devices. Manufacturers must also ensure that their technical documentation is comprehensive and aligned with harmonised standards to demonstrate compliance with the new MDR rules.
What countries does MDR apply to?
The MDR applies to all countries within the European Union. Additionally, non-EU countries such as Switzerland, Norway, Iceland, and Liechtenstein, also adopt the MDR for medical devices marketed within their territories. Manufacturers wishing to sell medical devices in these regions must comply with the MDR requirements, ensuring safety and regulatory compliance.
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