Meet us at MEDICA 2025! 📅 Nov. 17–20 | Hall 3 Booth D43 | Schedule a meeting

EU Flag

EU Expands Harmonised Standards for MDR: Focus on Medical Gloves, Sterilisation, and Patient Transport Equipment

The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the Medical Device Regulation (MDR, EU 2017/745). The latest update, formalised through Commission Implementing Decision (EU) 2025/681, introduces new harmonised standards covering medical gloves for single use, sterilisation of medical devices, and patient handling equipment in ambulances.

Key Highlights of the New Harmonised Standards

1. Medical Gloves for Single Use

The revised standards for medical gloves address both the requirements for freedom from holes and the physical properties of gloves. The new harmonised standards are:

  • EN 455-1:2020+A2:2024: Specifies requirements and testing for freedom from holes.
  • EN 455-2:2024: Details requirements and testing for physical properties of single-use medical gloves.

These updates ensure higher safety and performance levels for gloves used in healthcare, directly supporting infection control and patient safety.

2. Sterilisation of Medical Devices

Sterilisation remains a cornerstone of medical device safety. The new harmonised standards are:

  • EN 556-1:2024: Sets requirements for terminally sterilised medical devices to be designated as "STERILE".
  • EN 556-2:2024: Covers requirements for aseptically processed medical devices.

These standards support manufacturers in demonstrating compliance with sterility requirements, a critical aspect of MDR conformity assessment.

3. Patient Handling Equipment in Ambulances

The safe and effective transport of patients is vital in emergency medical services. The updated standards include:

  • EN 1865-2:2024: Focuses on power-assisted stretchers used in ambulances.
  • EN 1865-6:2024: Introduces requirements for powered chairs used in ambulances.

These standards address both the technical and safety requirements for patient transport equipment, ensuring interoperability, safety, and ergonomic design across EU member states.

The Impact of Harmonised Standards

Harmonised standards provide manufacturers and other stakeholders with a clear pathway to demonstrate conformity with essential requirements under the MDR. By aligning with these standards, manufacturers benefit from a “presumption of conformity,” streamlining market access and enhancing patient safety across the EU.

The process of harmonisation is overseen by European Standards Organizations (CEN, CENELEC, and ETSI) in response to requests from the European Commission. The latest standards reflect the latest technical and scientific advancements, ensuring that EU regulations remain robust and fit for purpose.

For further details, the full text of Commission Implementing Decision (EU) 2025/681 can be found on the EUR-Lex website.

Latest news

Implications of the Update to the Borderline & Classification Manual under MDR and IVDR

Implications of the Update to the Borderline & Classification Manual under MDR and IVDR

On 12 September 2025, the European Commission published Version 4 of the Manual on Borderline and Classification under Regulations (EU) 2017/745 and 2017/746, developed by the Borderline and Classification Working Group (BCWG).

Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR

Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR

European regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) require precise definitions in technical documentation, and the distinction (or overlap) between intended purpose and intended use remains a topic of operational significance.

MedNet EC-REP GmbH at MEDICA 2025 – Visit Us in Hall 3, Booth D43

MedNet EC-REP GmbH at MEDICA 2025 – Visit Us in Hall 3, Booth D43

MedNet EC-REP GmbH is pleased to announce that we will once again be exhibiting at MEDICA 2025 in Düsseldorf, the world’s leading trade fair for the medical technology industry.

EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know

EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know

The European Commission has introduced a significant amendment to Implementing Regulation (EU) 2021/2226, impacting how medical device manufacturers provide instructions for use (IFU).

Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6

Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6

Recently, the MDCG, in conjunction with the Joint Artificial Intelligence Board (AIB), released the MDCG 2025-6 FAQ document, offering essential clarifications on the interplay between the MDR, the IVDR, and the Artificial Intelligence Act (AIA).

Navigating IVDR and MDR Performance Studies: Key Insights from MDCG 2025-5 Q&A

Navigating IVDR and MDR Performance Studies: Key Insights from MDCG 2025-5 Q&A

The European Medical Device Coordination Group (MDCG) has released its latest guidance, MDCG 2025-5, a comprehensive Questions & Answers document addressing performance studies for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).

MDCG 2019-11 Rev.1: Important Changes for Medical Device Software Developers

MDCG 2019-11 Rev.1: Important Changes for Medical Device Software Developers

In the dynamic world of medical device regulation, staying abreast of the latest guidance is paramount for manufacturers. The Medical Device Coordination Group (MDCG) has recently released a significant update to its MDCG 2019-11 guidance document, now designated as MDCG 2019-11 Rev.1.

MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms

MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms

The European Commission's Medical Device Coordination Group (MDCG) has released the MDCG 2025-4 guidance document, titled "Guidance on the safe making available of medical device software (MDSW) apps on online platforms."