The Medical Device Coordination Group (MDCG) regularly publishes Guidance Documents and Guidelines on the interpretation and practical implementation of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Since January 2025, numerous new documents have been published and existing guidance documents have been updated. The following overview summarizes the key changes and highlights the potential impact these may have on manufacturers, Notified Bodies, and other economic operators
Legislation / Consolidated Regulations
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Reference |
Document title |
Status |
Key changes |
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Commission Implementing Regulation
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May 2026 |
· Defines uniform requirements for the QMS and conformity assessment procedures · Ensures a harmonized application of the regulations across the EU and to improve the consistency and predictability of assessments · Quotations must be transparent and include both estimated total costs and realistic deadlines · Mandatory maximum timelines for all key steps of the conformity assessment process · Publication of annual activity reports by Notified Bodies from January 1, 2028, onwards · Enters into force on February 25, 2027
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Borderline and Classification
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Reference |
Document title |
Status |
Key changes |
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Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 |
April 2026 |
Updated guidance documents · on determining whether a product is a medical device (or an in vitro diagnostic medical device or another product) · on dealing with borderline cases · on the application of classification rules under the MDR and IVDR |
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Guidance on classification of medical devices |
April 2026 |
· Updated: Rule 22 (active therapeutic devices with an integrated diagnostic function, “closed-loop”) – practical guidance on classification and a new note added |
Clinical investigation and evaluation, performance studies and evaluation
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Reference |
Document title |
Status |
Key changes |
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Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 |
June 2025 |
· This Q&A document explains the regulatory requirements for performance studies under the IVDR, including when applications or notifications are required and how analytical and clinical performance must be demonstrated · It provides practical guidance for manufacturers, sponsors, and investigators on study design, responsibilities, and documentation |
EUDAMED (EUDAMED Information Centre)
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Reference |
Document title |
Status |
Key changes |
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MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use |
June 2026 |
· Updated registration requirements: Revised procedures for manufacturers to upload validated SSCPs/SSPs to EUDAMED and for Notified Bodies to upload certificates · Transitional period until the new EUDAMED functionalities become available; for products already placed on the market, deadlines apply until February 27, 2027 · Alignment of implementation timelines is required |
European Medical Device Nomenclature (EMDN)
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Reference |
Document title |
Status |
Key changes |
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2026 EMDN Version History |
April 2026 |
Information on annual EMDN code revision |
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2025-2026 Annual Revision Change Log |
April 2026 |
Information on annual EMDN code revision |
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Summary of EMDN 2025 Submissions and outcome of annual revision |
April 2026 |
Information on annual EMDN code revision |
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2024-2025 Annual Revision Change Log |
January 2025 |
Information on annual EMDN code revision |
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Summary of EMDN 2024 Submissions and outcome of annual revision |
January 2025 |
Information on annual EMDN code revision |
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EMDN Ad hoc procedure |
January 2025 |
Information on annual EMDN code revision |
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Procedures for the updates of the EMDN |
January 2025 |
Information on EMDN code revision |
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FAQ on the European Medical Device Nomenclature (EMDN) |
January 2025 |
Information on EMDN code revision |
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Guidance on the EMDN Version History document |
April 2026 |
Information on EMDN code revision |
Article 10a – Interruption or discontinuation of supply
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Reference |
Document title |
Status |
Key changes |
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Q&A Obligation to inform in case of interruption or discontinuation of supply |
April 2026 |
· Explains the practical requirements of Article 10a of the MDR/IVDR regarding the notification of planned interruptions or discontinuations in the supply of medical devices and IVDs, including notification obligations, notification deadlines, risk assessment, and the actors affected within the supply chain · Applies to manufacturers, authorized representatives, and competent authorities where foreseeable supply interruptions or cessation of supply could lead to a serious risk to patients or public health
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New Technologies
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Reference |
Document title |
Status |
Key changes |
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Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 |
December 2025 |
· Defines the criteria and regulatory pathways for EU “Breakthrough Devices” intended to address an urgent medical need of major public health significance, and enables proportionate evidence requirements as well as earlier patient access · Covers novelty, clinical impact, unmet medical need, and post-market evidence obligations, including PMCF/PMPF
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FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) |
June 2025 |
· Explains how the AI Act complements the MDR and IVDR and clarifies that high-risk AI medical systems must comply with all three regulatory frameworks through integrated quality management, risk management, and technical documentation processes · Highlights new requirements for data governance, transparency, human oversight, and post-market monitoring · Serves as structured FAQs to align the compliance expectations of manufacturers and authorities without introducing new obligations beyond the existing legislation |
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Guidance on the safe making available of medical device software (MDSW) apps on online platforms |
June 2025 |
· Clarifies the regulatory responsibilities of app platform providers and manufacturers of medical device software (MDSW) under the MDR/IVDR and the Digital Services Act for the safe provision of medical software applications · Emphasizes transparency and information obligations, as well as the correct categorization of apps as medical devices or as lifestyle or health apps |
Post-Market Surveillance and Vigilance (PMSV)
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Reference |
Document title |
Status |
Key changes |
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Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices |
December 2025 |
· Describes the post-market surveillance (PMS) system, the PMS plan, and the key activities within the PMS system · Clarifies the interaction of the PMS system under Article 83 MDR and Article 78 IVDR with other key elements of the quality management system (QMS), as described in Article 10(9) MDR and Article 10(8) IVDR · Annex II: Scenarios for in vitro diagnostic medical devices (IVD) and medical devices illustrating the use of PMS data to update other processes |
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Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 |
January 2025 |
· Explains the vigilance terminology and reporting requirements under the MDR and IVDR and answers practical questions on serious incidents, field safety corrective actions (FSCAs), trend reporting, and manufacturers’ reporting obligations |
Unique Device Identifier (UDI)
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Reference |
Document title |
Status |
Key changes |
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Position Paper: UDI assignment between manufacturers and distributors |
July 2026 |
· Clarifies UDI assignment responsibilities between manufacturers and distributors |
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Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles |
March 2026 |
· Explains the implementation of the Master UDI-DI concept for highly individualized optical devices · Addresses UDI assignment rules, labelling, and EUDAMED registration |
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MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles |
December 2025 |
· Outlines the mandatory implementation timelines for the Master UDI-DI for highly individualized products such as contact lenses, spectacle frames, ophthalmic lenses, and ready-to-ware reading spectacles · Specifies phased deadlines: · November 2026 for contact lenses · September 2028 for spectacle frames and ophthalmic lenses · Recommends early voluntary implementation to improve traceability and vigilance
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Guidance on the implementation of the Master UDI-DI solution for contact lenses |
August 2025 |
· Specifies registration requirements for contact lenses (UDI and EUDAMED) |
In Vitro Diagnostic medical devices (IVD)
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Reference |
Document title |
Status |
Key changes |
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Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 |
March 2025 |
· Explains the classification rules and conformity assessment procedures set out in Annex VIII of the IVDR · Supports manufacturers and Notified Bodies in the consistent classification of IVD devices into classes A, B, C, or D · Provides practical examples and clarifications on the individual classification rules |
Standards
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Reference |
Document title |
Status |
Key changes |
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Transition to the "EU REP" symbol in EN ISO 15223-1 |
June 2026 |
· Provides information on the update of the EU authorized representative symbol to “EU REP” in accordance with EN ISO 15223-1:2021/A1:2025 · No approval by the Notified Body is required for this change; the transition and coexistence period runs until January 2031 (5 years) |
Source: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en / As of 29 July 2026
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