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Monthly summary of regulatory updates

This page summarizes updates to the entire ecosystem of regulatory sources governing the medical device sector. Further details regarding the sources and their hierarchy are available here.

04/2026

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

updated
MDCG 2021-24 rev.1
Guidance on classification of medical devices (April 2026)
updated
Manual on Borderline and Classification under Regulations (EU) 2017/745 and 2017/746, v5
new
MDCG 2026-1
Summary of requests submitted to EMDN in 2025 and results of the annual review
new
MDCG 2026-2
Change log of the 2025-2026 annual revision
new
MDCG 2026-3
EMDN 2026 version history
updated
MDCG 2021-12 rev.2
Frequently Asked Questions on the European Medical Device Nomenclature (EMDN)
new
New manufacturer incident report (MIR 7.3.1. PDF form - SB 11154)

Harmonized standards published in the Official Journal (new and updated)

No updates to report.

Circulars from the Italian Ministry of Health

new
Circular 18/04/2026
Further operational guidance for the transmission to the Ministry of Health of incident reports involving medical devices, devices listed in Annex XVI of Reg. (EU) 2017/745 and in vitro diagnostic medical devices by economic operators
new
Circular 21/04/2026
Further operational guidance for the transmission to the Ministry of Health of incident reports involving medical devices, devices listed in Annex XVI of Reg. (EU) 2017/745 and in vitro diagnostic medical devices by economic operators
03/2026

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

updated
Rev. 2 - Questions and answers: Notification obligation in case of interruption or discontinuation of supply

Harmonized standards published in the Official Journal (new and updated)

published
EN 13060:2025
Small steam sterilizers - Requirements and test methods
published
EN 14222:2021+A1:2025
Stainless steel shell boilers

Circulars from the Italian Ministry of Health

No updates to report.

02/2026

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

No updates to report.

Harmonized standards published in the Official Journal (new and updated)

No updates to report.

Circulars from the Italian Ministry of Health

new
Circular 24/02/2026
Operational guidelines for the transmission to the Ministry of Health of incident reports involving medical devices, devices listed in Annex XVI of Regulation (EU) 2017/745, and in vitro diagnostic medical devices by economic operators
01/2026

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

No updates to report.

Harmonized standards published in the Official Journal (new and updated)

published
EN ISO 7197:2024
Neurosurgical implants - Sterile, single-use hydrocephalic shunts (ISO 7197:2024)
published
EN ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) - EN ISO 10993-4:2017/A1:2025
published
EN ISO 14155:2020
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020) - EN ISO 14155:2020/A11:2024
published
EN ISO 14630:2024
Non-active surgical implants - General requirements (ISO 14630:2024)
published
EN ISO 17665:2024
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
published
EN ISO 18562-1:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
published
EN ISO 18562-2:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
published
EN ISO 18562-3:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (ISO 18562-3:2024)
published
EN ISO 18562-4:2024
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
published
EN ISO 21535:2024
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)
published
EN ISO 21536:2024
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)
published
EN ISO 80369-2:2024
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for breathing systems and driving gases (ISO 80369-2:2024, Corrected version 2025-06)
published
EN ISO 18113-1:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2022)
published
EN ISO 18113-2:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
published
EN ISO 18113-3:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
published
EN ISO 18113-4:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
published
EN ISO 18113-5:2024
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

Circulars from the Italian Ministry of Health

No updates to report.

12/2025

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

new
MDCG 2025-10
Guidelines on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025)
updated
MDCG 2025-7 - Rev. 1
MDCG position document: Implementation timelines for "Master UDI-DI" for contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading glasses
new
MDCG 2025-9
Guidelines on innovative devices (BtX) under regulations 2017/745 and 2017/746

Harmonized standards published in the Official Journal (new and updated)

No updates to report.

Circulars from the Italian Ministry of Health

No updates to report.

11/2025

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

No updates to report.

Harmonized standards published in the Official Journal (new and updated)

published
Decision (EU) 2025/2371 of 26 November 2025 - Eudamed
Notice concerning the functionality and compliance with functional specifications of certain electronic systems forming part of the European database on medical devices referred to in Article 34, paragraph 1, of Regulation (EU) 2017/745 of the European Parliament and of the Council

Circulars from the Italian Ministry of Health

No updates to report.

10/2025

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

No updates to report.

Harmonized standards published in the Official Journal (new and updated)

published
EN 13795-1:2025
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
published
EN 13795-2:2025
Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
published
EN 14180:2025
Sterilizers for medical use - Low temperature steam and formaldehyde sterilizers - Requirements and testing
published
EN 14683:2025
Medical face masks - Requirements and test methods

Circulars from the Italian Ministry of Health

No updates to report.

09/2025

MDR

No updates to report.

Delegated acts

No updates to report.

Implementing acts

No updates to report.

MDCG

updated
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v4
The agreements reached between member states of the Borderline and Classification Working Group (BCWG) regarding the qualification and classification of borderline medical devices

Harmonized standards published in the Official Journal (new and updated)

No updates to report.

Circulars from the Italian Ministry of Health

No updates to report.

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