March 2025 – Medical Devices Regulatory Insights

UK Medical Device Regulator MHRA Announces Legislative Updates

After the new legislation was laid out on 21 October 2024, a six-month transition period is provided, whereafter the amended regulations will come into force on June 16, 2025. This period allows stakeholders to adapt their processes and ensure compliance with the new requirements.

In January 2025, the MHRA published a guidance directly relating to SI 2024 No. 1368, it serves as an interpretative document to facilitate the implementation of the amended regulations. It aims to assist manufacturers, notified bodies, and other stakeholders in understanding and fulfilling their obligations under the new PMS framework.

Original Source: Guidance – PMS Requirements Amendment
Published: 15 January 2025

MHRA Pilots Five AI Techs to Revamp Regulations

The pilot scheme, AI Airlock, was launched to support AI-driven medical device development under UK MDR 2002, has selected four innovative technologies for sandbox testing since the 5th technology Lenus Health withdrew from the pilot. Testing is ongoing, with a target completion for the pilot phase by April 2025.

The pilot aims to validate AI-driven medical technologies while ensuring compliance with evolving UK regulatory standards.

Original Source: AI Airlock Published: 28 February 2025

TEAM NB: New Training for Manufacturers.

The European Association of Medical Devices Notified Bodies has developed and delivering training courses for manufacturers in response to actions associated with Notified bodies (MDCG 2022-4) specifically supporting Small and Medium Enterprises by enhancing their understanding of the legislative requirements.

The new half-day training date has been released and is taking place 7 May 2025.

For more information
Register here

Original Source: New Training
Published: 14 March 2025

Call for applications!!

The Member of State supported by the European Commission launched a pilot program for coordinated assessment of clinical investigations and performance studies. Only medical devices are at this stage; IVD will follow at a later stage.

Submission deadline: 30 June 2025
Expression of interest form: Here

Original Source: Pilot coordinated assessment for CI/PS
Published: 6 February 2025

Guidance documents issued by the Medical Device Coordination Group (MDCG)

MDCG has issued guidance documents over the past three months, see below. The European Medical Device Nomenclature (EMDN), a standardised system under the MDR and IVDR for manufacturers to register devices on EUDAMED released several updates in January 2025, see links below.

The MDCG 2020-16 saw a revision in January, providing more detailed explanations and examples for each classification rule, see link below.

January 2025
MDCG 2021-12 rev.1: FAQ on the European Medical Device Nomenclature (EMDN)
MDCG 2024-2 rev.1: Procedures for the updates of the EMDN
MDCG 2025-1: EMDN Ad hoc procedure
MDCG 2025-2: Summary of EMDN 2024 Submissions and outcome of annual revision
MDCG 2025-3: EMDN Version History
MDCG 2023-3 rev.2: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746

February 2025
MDCG 2019-6 Rev5: Questions and answers: Requirements relating to notified bodies

March 2025
MDCG 2020-16 rev.4: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Update on SARS-Cov-2 IVD (EU) classification

The European Commission published MDCG 2020-16 rev.4 guidance, after the EC IVD expert panel concluded that SARS-Cov-2 no longer presents a life-threatening risk with significant mortality for the general European population. This decision impacts the classification of SARS-Cov-2 tests, and the guidance is there to help manufacturers navigate regulatory requirements with greater certainty.

Original Source: MedTech Europe
Published: 5 February 2025

The call for EU to join MDSAP

MedTech Europe and COCIR called for the European Union to join the Medical Device Single Audit Program (MDSAP) as a full member, and to enable the recognition of MDSAP certificates for the purpose of CE marking medical devices and in vitro medical devices.

How will this benefit manufacturers?

• Enhanced Global Regulatory Harmonization: reduces discrepancies between different regulatory systems.
• Streamlined Audit Processes: Manufacturers would benefit from a single, comprehensive audit that satisfies multiple regulatory authorities, thereby reducing the complexity and frequency of audits.
• Accelerated Patient Access to Innovations: Streamlined certification processes enable quicker introduction of new medical technologies to the market, ensuring that patients have timely access to innovative treatments and devices.

Original Source: Joint reflection paper
Published:17 February 2025

Clarity needed on clinical strategy discussions for Manufacturers

MedTech Europe, the European Self-Care Industry Association (AESGP), the MedTech & Pharma Platform and COCIR have expressed their concerns that the recently updated MDCG 2026-6 rev5, does not address the ongoing absence of clinical strategy discussion in the pre-submission space. Their joint paper highlights the concern that the update does not allow manufacturers to discuss clinical strategy before submitting an application for conformity assessment. This gap leads to unpredictability in regulatory approvals and risks delays in market access.

Their proposed solutions include:

1. MDR Implementing Act Revision: ‘The discussion on clinical strategy should take place before submission in order to increase predictability and timely availability of medical devices and IVDs.’
2. Structured Pre-Submission Process: Manufacturers should submit a summary of their clinical strategy to the Notified Body before a scheduled meeting. Also Notified Bodies should provide high-level feedback but not detailed guidance.

Original Source: Joint paper
Published: 6 March 2025

Impact of FDA layoffs on the medical device industry

The recent layoffs at the U.S. Food and Drug Administration (FDA) have raised significant concerns within the medical device industry. These cuts, affecting approximately 200 FDA employees funded under the Medical Device User Fee and Modernization Act of 2002, have led to fears of delays in the approval process for new medical devices, potentially hindering timely access to innovative technologies for patients. Industry leaders, such as AdvaMed CEO Scott Whitaker, have expressed apprehension that these reductions could slow device review times, compromising patient care and the United States’ leadership in medical innovation.

Furthermore, the layoffs have impacted divisions overseeing artificial intelligence-driven medical technologies, raising concerns about prolonged review times and potential setbacks in medical advancements.

Although the FDA layoffs do not directly impact the European medical device industry’s regulatory processes, such changes can influence market dynamics, product availability, and strategic decisions across regions.

Original Source: AdvaMed CEO Scott Whitaker
Published: 19 February 2025

TGA recognises specific international regulatory authorities

In January 2025 TGA updated a guidance document outlining how manufacturers and sponsors can leverage approvals from recognised international regulatory bodies to streamline the conformity assessment and inclusion processes for medical devices and in vitro diagnostic devices (IVDs) in the Australian Register of Therapeutic Goods (ARTG). The recognised authorities include:

• EU MDR/IVDR
• United States Food and Drug Administration (FDA)
• Health Canada
• Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
• Singapore Health Sciences Authority (HSA)
• Medical Device Single Audit Program (MDSAP) Auditing Organisations

This will benefit Manufacturers!

Manufacturers with existing approvals from these recognised bodies may qualify for an abridged conformity assessment by the TGA, potentially reducing the time and resources required for ARTG inclusion.

This guidance aims to enhance regulatory efficiency by acknowledging the rigorous assessments conducted by comparable overseas regulators, thereby facilitating timely access to medical devices and IVDs for Australian patients and healthcare providers.

Original Source: Guidance
Published: 23 January 2025

TGA recall reforms program

The Therapeutic Goods Administration, Australia’s medical device regulation, has issued a procedure for Recalls, Product Alerts, and Product Corrections (PRAC). The system was first set up in March 2024 and was called the Uniform Recall Procedure for Therapeutic Goods (URPTG), after which changes were made to the name and now referred to as PRAC.

The published presentation ensures that the transition from the URPTG to the PRAC is seamless, addressing stakeholder concerns and featuring extensive side-by-side comparisons between the two documents. The presentation explains where the process has changed and what our stakeholders can expect to stay the same.

Original Source: PRAC Presentation
Published: 12 March 2025

Audit rules for Medical Devices (TGA)

TGA revised their guidance document on helping “sponsors” understand application audit rules for medical devices, including in-vitro diagnostics (IVDs) when submitting an application in the Australian Register of Therapeutic Goods (ARTG). This update primarily revised the section on “Applications that must be selected for audit”, focusing mandatory application audits on high-risk medical devices and IVDs.

Mandatory Audits for High-Risk Devices: The TGA now requires mandatory audits, accompanied by assessment fees, for applications concerning:

• Class III Medical Devices
• Class 3 and Class 4 IVDs
• IVDs Intended for Self-Testing or Point-of-Care Testing
• Class 4 In-House IVDs.

Original Source: Mandatory Audits
Published: 16 January 2025

Health Canada: Class II to IV medical devices

Health Canada published a guidance document on the terms and conditions for class II to IV medical devices that will come into force on 1 January 2026.

This guidance aims to enhance the oversight of medical devices by ensuring that T&CS can be applied to manage potential risks effectively, thereby safeguarding public health.

Original Source: Guidance of T&Cs
Published: 25 February 2025

Upcoming Notable Med-Tech events 2025

Surg-Tech 2025: 3-4 April 2025, Leeds, England
Come say Hello at the SimpliMedica stand!
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Nexus Connect: 29 April 2025
Leeds, England
Come say Hello at the SimpliMedica stand!
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LSX World Congress: 28-30 April 2025
London, England
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The Future of MedTech – Innovating for Tomorrow: 13-14 May 2025
Northampton, England
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The MedTech Forum: 13-15 May 2025
Lisbon, Portugal
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Med-Tech Innovation Expo: 4-5 June 2025
Birmingham, England
Come say Hello at the SimpliMedica stand!
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MedTech Summit – Regulatory Conference in Europe: 16-20 June 2025
Berlin, Germany
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