December 2024 – Medical Devices Regulatory Insights
UK Medical Device Regulator MHRA Announces Legislative Updates
The Post-market Surveillance (PMS) Statutory Instrument (SI) laid in Parliament on 21 October 2024 was the first major update to the framework of medical device regulations in Great Britain.
Since January 2021 all medical devices have been required to be registered with the MHRA before they can be placed on the market in Great Britain a step-change in the Agency’s oversight of medical devices, allowing us to take more rapid action where safety concerns are identified.
By introducing clear, risk-proportionate requirements, the new legislation laid on the 21st of October will build on measures already introduced to improve patient safety, facilitating greater traceability of incidents and reporting trends.
Comprehensive guidance to support manufacturers with implementation and compliance will be published once the Parliamentary process has been concluded.
The SI proposes a six-month implementation period once Parliamentary processes have been concluded. This regulation could, therefore, become law in Summer 2025.
Original Source: New Legislation Published: 22 October 2024
MHRA Pilots Five AI Techs to Revamp Regulations
The pilot scheme, AI Airlock, has been designed to better understand how we can regulate artificial intelligence (AI) powered medical devices and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively.
Five innovative technologies have been selected by the MHRA for the AI Airlock. These novel medical devices have the potential to significantly improve the diagnosis and care of patients. Those selected for the pilot include medical devices for cancer and chronic respiratory disease patients as well as those requiring radiology diagnostic services.
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said:
“New AI medical devices have the potential to increase the accuracy of healthcare decisions, save time, and improve efficiency, leading to better outcomes for the NHS and patients across all healthcare settings.
“But we need to be confident that AI-powered medical devices introduced into the NHS are safe and stay safe and perform as intended throughout their lifetime of use.
“By examining the technologies announced today in a safe setting, in partnership with technology specialists, developers, and the NHS, we can test and improve the rules for AI-powered medical devices, helping get products like these to the hospitals and patients who need them sooner.”
Original Source: AI Airlock Published: 4 December 2024
The MHRA calls for your views on pre-market regulations for medical devices to improve patient access and strengthen patient safety
The MHRA launched a consultation on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. The consultation will close on 5 January 2025. The consultation focuses on four policy areas namely:
1) UKCA marking
2) International reliance
3) In vitro diagnostic (IVDs) devices
4) Assimilated EU law including Commission Decision 2002/364, Commission Regulation (EU) No 207/2012, Regulation (EU) No 722/2012, and Regulation (EU) No 920/2013.
You can take part in the consultation here. The MHRA welcomes views from all interested stakeholders.
Original Source: Consultation Published: 14 November 2024
MDR Technical Documentation Training for Manufacturers.
The European Association of Medical Devices Notified Bodies has developed and delivered 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 last training held on 6 November 2024 was 1 of 7 for the year, Keep an eye on the TEAM NB website for 2025 training release dates.
Original Source: Press release: Training Published: 26 November 2024
EUDAMED gradual roll-out
On 9th July 2024, the amending Regulation (EU) 2024/1860 was published in the Official Journal of the European Union (OJEU) with immediate effect.
On 21 November 2024 the European Commission published Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860. The published document covers 20 useful questions for stakeholders.
Original Source: EUDAMED Q&A Published: 21 November 2024
Implementation rolling plan
The rolling plan for the implementation of REGULATION (EU) 2021/2282 on health technology assessment (the “HTAR”) contains a list of key activities that the Commission has carried out or intends to carry out in preparation for the implementation. The plan is subject to regular review to provide national authorities and stakeholders with the most updated information, the last update was September 2024. The HTAR entered into force on January 11, 2022. It will be applicable as of January 12, 2025
Original Source: Rolling Plan Published: 27 September 2024
Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). These EURLs will be involved in conformity assessment of high-risk (class D) IVDs and carry out certain advisory tasks.
The implementing act includes transitional arrangements to allow the EURLs to form a network and harmonize their working methods, and for manufacturers and notified bodies to adapt their processes to include EURL testing. The EURLs are expected to take up their tasks in the conformity assessment of devices on 1st October 2024.
Performance verification, as part of the initial conformity assessment, will only apply to devices where applications are lodged with a Notified Body after 1st October 2024 as per Art 2.3, meaning:
- Class D Devices under application or already certified per IVDR, prior to 1st October 2024, will not require EURLs involvement in the initial conformity assessment for CE marking.
- Batch verification testing will be applicable from 1 October 2024 for all Class D devices that are already certified or undergoing conformity assessment.
Note that Class D IVDs that fall outside of the scope of a designated EURLs, will continue to be assessed by the Notified Body, through alternative means:
- No EURLs are involved in the conformity assessment for these devices, at the moment.
Original Source: BSI Published: 26 September 2024
Guidance documents issued by the Medical Device Coordination Group (MDCG)
MDCG has issued guidance documents over the past three months, see below. The European Commission published a DASHBOARD which presents the data of the ongoing study “Monitoring availability of medical devices on the EU market”, the study is planned to run until December 2025.
September 2024
MDCG 2021-4 Rev.1: Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
October 2024
MDCG 2024-12: Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams
MDCG 2024-11: Guidance on qualification of in vitro diagnostic medical devices
MDCG 2021-25 Rev.1: Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC
MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices
MDCG 2022-5 Rev.1: Guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
November 2024
MDCG 2023-3 Rev.1: Questions and Answers on vigilance terms and concepts as outlined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
Questionnaire about Artificial Intelligence in Medical Devices.
MDCG 2024-14: Guidance on the implementation of the Master UDI-DI solution for contact lenses.
December 2024
MDCG 2024-15: Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED.
Recommendation for guidance Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
FDA issued a guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in the guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.
The guidance recommends that a PCCP describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for an AI-enabled device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. The recommendations in the guidance apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways.
The recommendations in the guidance build on the FDA’s longstanding commitment to developing and applying innovative approaches to the regulation of AI-enabled devices.
Original Source: FDA Guidance Published: 4 December 2024
Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment
FDA issued a guidance to provide clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. The FDA defines diagnostic x-ray systems as both a medical device and an electronic product, therefore these systems are subject to the provisions of the FD&C Act that apply to both medical devices and to electronic products, and their implementing regulations. This guidance document only addresses the requirements that apply to diagnostic x-ray equipment under the electronic product provisions of the FD&C Act and the regulations implementing those provisions. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installing of electronic products. It does not address requirements that may apply to diagnostic x-ray equipment as medical devices.
This guidance supersedes FDA’s guidance entitled “Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment” (HHS Publication FDA 89-8221 issued in March 1989).
Original Source: Radiation control guidance Published: 30 September 2024
IVD sponsors: a roadmap to market
The Therapeutic Good Administration (Australian Medical Device Regulators) issued a road map for Australian sponsors of In Vitro Diagnostic (IVD) medical devices.
It highlights the requirements for supplying an IVD under the medical device’s regulatory framework.
The appropriate pathway is determined by the manufacturer’s classification of the IVD.
Original Source: TGA Roadmap Published: 25 November 2024
Submitting a Custom-Made Medical Device (CMMD) notification
TGA published a step-by-step guide for manufacturers and sponsors who manufacture, supply, or import a kind of Custom-Made Medical Device (CMMD). They are required to notify the TGA within 2 months of manufacture or initial supply of the CMMD.
Under the Australian regulatory framework for medical devices, ‘custom-made’ medical devices are exempt from the requirement to be included in the ARTG. However, they are not exempt from regulation.
Manufacturers and sponsors of custom-made medical devices still need to comply with TGA regulatory requirements. These include:
- making sure the device(s) meets all relevant Essential Principles
- complying with advertising requirements
- submitting annual reports, and
- reporting adverse events.
Original Source: Step-by-step guide Published: 7 November 2024
Regulatory changes for custom-made medical devices
TGA published a document providing information and examples to help manufacturers understand the Australian regulatory framework for personalised medical devices (the Framework) and provide them with information and examples about how these devices are regulated and their regulatory obligations if you are manufacturing or supplying a personalised medical device. The intention of the examples is not to tell you how every device is regulated but to provide enough information to help you identify the concepts and boundaries in the Framework so you can apply these concepts to your own circumstances.
Original Source: Guidance Published: 17 October 2024