Our September 2023 MedTech news roundup includes updates from Swissmedic on Swissdamed, from the EU Commission regarding the extended MDR transitional period, and from Team NB concerning legacy devices surveillance transfer.
We also cover news from the UK’s MHRA regarding new approved bodies, guidances on clinical investigation intention and MORE submissions respectively, as well as the latest from the FDA on cybersecurity, ISO 10993-1, 510(k) program modernisation, AR & VR medical devices, and devices with weight loss indications. For this and more, read on…
MedTech news from Switzerland and Europe
Updated release timeline shared for Swissdamed modules
Swissmedic has published details about the planned release timeline for the Swissdamed modules.
The Swissdamed application (the Swiss Database on Medical Devices), is a Swissmedic IT system that enables the application of Swiss regulations on medical devices and in vitro diagnostic medical devices. Swissdamed is structured around two interconnected modules that are accessible only by registered users – the Act module for the registration of economic operators, and the UDI module for the registration of medical devices.
The latest release dates shared by Swissmedic are as follows:
- Early 2024 | ACT module for the registration of economic operators
- Early 2024 | Swissdamed – freely accessible platform
- Summer 2024 | UDI module for the registration of devices
Read more about Swissdamed here.
Is your device covered by the extended MDR transitional period? EU Commission shares clarity
The EU Commission has published a flowchart to assist manufacturers in deciding whether a medical device is covered by the extended MDR transitional period outlined in Article 120 of Regulation (EU)2017/745 on medical devices, as amended by Regulation 2023/607.
The chart aims to help determine the eligibility, conditions, and deadlines for placing certain devices on the market/putting them into service, in accordance with Article 120 of the MDR.
You can access the flowchart here.
Team NB shares position paper on legacy devices surveillance transfer agreement
Team NB has published a position paper regarding the transfer agreement for surveillance of legacy medical devices. The paper specifies the terms of the transfer of the appropriate surveillance activities according to Article 120 (3e) of the EU MDR in respect of legacy devices covered by a certificate issued under Directive 90/385/EEC or Directive 93/42/EEC. Find out more here.
The latest MedTech updates from the UK
Three new UK Approved Bodies announced
The UK’s MHRA has designated three new UK Approved Bodies to certify medical devices.
TÜV SÜD and Intertek have been designated to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002, whilst TÜV Rheinland UK has been designated to assess and certify general medical devices and IVDs in accordance with Part IV.
The move almost doubles the UK’s capacity to certify medical devices, with the aim of supporting faster certification of safe and effective medical devices for healthcare professionals and the public.
MHRA updates guidance on clinical investigation intention
The MHRA has updated its guidance on how to notify them of your intention to carry out a clinical investigation for medical devices.
The recent updates include added information on fees payable in relation to clinical investigation and amendments to clinical investigations, and the inclusion of Medical devices: Clinical investigations and performance studies in Northern Ireland.
For more information, see here.
Updated guidance shared for MORE submissions
The Manufacturer’s On-line Reporting Environment (MORE) portal exists for the submission of post-market vigilance reports regarding device related incidents in the UK. In April this year, a step-by-step guide on using the MORE platform was published, providing details on how to use the different functions for report submissions and how to manage reports.
Last month the guide was updated to include further guidance for draft reports. Find out more here.
MedTech news from the US
FDA publishes final cybersecurity in medical devices guidance
This week the FDA published its final guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
The guidance, which supersedes “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” issued 2 October 2014, provides FDA’s recommendations to industry regarding cybersecurity device design, labelling, and the recommended documentation to be included in premarket submissions for devices with cybersecurity risk. Read the final guidance here.
ISO 10993-1: Final guidance from the FDA
The FDA has developed guidance on the use of ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
The guidance seeks to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into direct or indirect contact with the human body, to determine the potential for an unacceptable adverse biological response.
This guidance document also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, and biocompatibility recommendations when certain materials only contact intact skin. Access the final guidance here.
FDA continues to modernise its 510(k) program
The FDA is continuing to modernise its 510(k) program with the release of several draft guidances providing updated recommendations on specific aspects of the program. The three draft guidances recently released cover:
- Best practices for selecting a predicate device to support a 510(k) submission
- Recommendations for the use of clinical data in premarket notification 510(k) submissions
- Evidentiary expectations for 510(k) implant devices
The release of these guidances forms part of the FDA’s ongoing efforts to keep pace with the increasing complexity of rapidly evolving technology, with this latest update to the 510(k) program aiming to improve patient accessibility to new and innovative MedTech.
Whilst these guidances are not currently for implementation, once finalised, they intend to help improve the safety and effectiveness of medical devices in the 510(k) program over time.
Augmented Reality & Virtual Reality medical devices: Resources for use & regulation
Medical extended reality (XR), which includes Augmented Reality and Virtual Reality has the potential to improve healthcare by facilitating new types of treatments and diagnosis tools – spanning developments in neurology, orthopaedics, radiology, and more.
Medical XR also provides opportunities to advance health equity, by enabling care at home, outside of hospital, or in the absence of a local specialist. As the benefits, risks, and long-term effects of medical XR continue to be studied, the FDA has provided a selection of resources on the considerations regarding its use and regulation.
FDA shares Voluntary Improvement Program policy
The FDA’s CDRH has issued guidance to describe its policy regarding FDA’s participation in the Voluntary Improvement Program (VIP).
The VIP is a voluntary program that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals.
Intended to guide improvement to enhance the quality of medical devices, this voluntary program is currently only available to eligible manufacturers of medical devices regulated by CDRH and whose marketing applications are reviewed under the applicable provisions of the FD&C Act (including under sections 510(k), 513, 515, and 520).
FDA shares guidance on medical devices with weight loss indications
The FDA has published two draft guidances regarding medical devices with indications associated with weight loss.
Due to the wide variety of medical device designs in this space, there can be variability in the demonstrated weight loss and risk associated with these devices, as well as variability in the applicability of some of the recommended testing.
One guidance covers the FDA’s recommendations regarding clinical study design for devices with indications for use associated with weight loss, and includes discussion on the benefit-risk analysis to support such indications.
The second draft guidance document provides the FDA’s recommendations for the non-clinical testing to support premarket submissions for medical devices with indications for use associated with weight loss.
You can access the two guidance documents at the links below:
Medical Devices with Indications Associated with Weight Loss – Non-Clinical Recommendations
CDRH issues updated final guidance on Breakthrough Devices Program
The FDA’s CDRH has issued an updated final guidance for the Breakthrough Devices Program. This final guidance is intended to help the FDA and its customers to leverage the interactive nature of the Breakthrough Devices Program to further advance health equity.
The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, aligning with CDRH’s Strategic Priority to Advance Health Equity.
That concludes our September 2023 MedTech news roundup. Check back in October for more medical device news and updates.
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