Our March 2024 MedTech news roundup covers new guidance from the MDCG on clinical investigation plan content, an update from Swissmedic on Swissdamed, and the latest from the EU Commission on harmonised standards under MDR.
MedTech news from the US also features, spanning the release of draft premarket cybersecurity guidance, a new paper on artificial intelligence in medical devices, and the latest FDA town hall on medical device sterilization. And keep reading for an update on UK MedTech regulatory reform from the MHRA, and the NMPA’s National Inspection Plan for medical devices.
For all this and more, read on…
MedTech news from the EU & Switzerland
MDCG shares new guidance on clinical investigation plan content
The MDCG has published guidance on the content of the clinical investigation plan (CIP) for clinical investigations of medical devices.
Whilst not legally binding, the guidance document has been developed following contributions from national competent authorities and industry stakeholders, and as such should be recognised as best practice.
MDCG 2024-3 has been written to support manufacturers developing their CIPs by describing what type of information is expected in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application.
Section 3 of Chapter II of Annex XV of the MDR describes the legally required content of the CIP, and has been used as a starting point for this guidance – which follows the numbering of the regulation to facilitate cross referencing to the legal requirements. The requirements of international standard ISO 14155:2020 as well as experience from the competent authorities has also been used to develop this guidance document.
The guidance is not intended to be a template for writing a clinical investigation plan, rather the content of a CIP should be adapted based on the type of clinical investigation and the type / development stage of the investigational medical device.
You can access the full guidance here.
Swissmedic defers Swissdamed go-live date
Since we last reported on Swissdamed module release timings in September 2023, a further update has been shared by Swissmedic. As at Quarter 1 this year (2024), development of the first ACT module (Release 1.1) has been completed in functional terms, and work on the UDI module is underway.
Furthermore, Swissmedic announced that Swissdamed is to now be taken into operation directly in the Swissmedic Cloud. Development of this new IT infrastructure, together with the associated transfer of Swissdamed, means that the “go-live” date has been deferred to the second half of 2024.
The planned release dates for individual modules now sit as follows:
- Registration of companies and economic operators – ACT module | Available in the second half of 2024
- Swissdamed as a freely accessible platform | Available in the second half of 2024
- Registration of devices – UDI module | Available as a minimal viable product four months after the ACT module goes live
Swissmedic communicated that in the meantime, the existing established channels are to be used for the registration of economic operators and updating of information.
Read more about Swissdamed here.
EU Commission amends harmonised standards for biological evaluation of medical devices under MDR
On 6 March, the EU Commission amended Implementing Decision (EU) 2021/1182 with Implementing Decision (EU) 2024/815 regarding harmonised standards for:
- Medical gloves for single use
- Biological evaluation of medical devices
- Sterilization of health care products
- Packaging for terminally sterilized medical devices, and
- Processing of health care products
EU Commission updates language requirements overview for medical device manufacturers
The EU Commission has updated its MDR and IVDR tables that outline the language requirements for the information and instructions that accompany a medical device in each Member State.
You can find the two updated tables here.
MedTech updates from the US
FDA releases draft premarket cybersecurity guidance for comment
This month the FDA released further draft guidance regarding cybersecurity that proposes select updates to “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, to align with the new requirements introduced by Section 524B of the FD&C Act.
The act mandates that manufacturers of “cyber devices” (defined as devices that include software capable of connecting to the internet and potentially vulnerable to cybersecurity threats) must ensure these devices meet specific cybersecurity requirements.
The guidance outlines who must comply, what devices are subject to the new rules, and documentation recommendations to fulfil Section 524B requirements. Specifically, it discusses plans and procedures for manufacturers, processes for assurance of cybersecurity, and the requirement for a software bill of materials (SBOM).
For device modifications that might affect cybersecurity, the guidance suggests different documentation requirements based on the potential impact of the changes.
The guidance emphasises that a “reasonable assurance of cybersecurity” is part of the FDA’s overall determination of a device’s safety and effectiveness. This includes evaluating any changes in the environment of use, new risks or vulnerabilities, and how these are addressed by the device design and performance testing.
You can read the draft guidance here.
FDA shares coordinated approach to Artificial Intelligence in new paper
On 15 March the FDA published “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” Representing the FDA’s coordinated approach to AI via cross-centre collaboration, the paper intends to complement the “AI/ML SaMD Action Plan” and outlines the FDA’s commitment to driving alignment and sharing learnings applicable to Artificial Intelligence in medical products more broadly.
Find out more about how the FDA is fostering responsible and ethical medical product innovation through AI here.
And for more information regarding Artificial Intelligence application in medical devices, take a look at our latest whitepaper.
FDA holds fifth medical device sterilization town hall
On 21 March the FDA held its fifth medical device sterilization town hall on the value and use of recognised consensus standards in premarket submissions.
During the session, the role of the CDRH Standards program in the development and recognition of consensus standards was discussed, as well as the recently recognised consensus documents for device sterility and their potential use in premarket review. The value of participating in the collaborative standards development process also featured on the agenda.
The regular town hall series is part of the FDA’s broader commitment to reducing reliance on Ethylene Oxide (EtO) gas sterilization use while ensuring the integrity of the medical device supply chain.
MedTech updates from the UK & China
UK’s MHRA shares update on UK MedTech regulatory reform
On 5 March the MHRA presented a webinar on plans for the upcoming changes to the medical devices legislation for the UK.
The session provided updates on the scope of the UK Medical Device Regulations, as well as regarding classification and essential requirements for medical devices, IVDs, and Software as a Medical Device.
Whilst no definitive timelines for implementation were discussed, reference was made to the roadmap published earlier this year, which provides an overview of the planned activities. However, it was emphasised that certain actions incorporated in the roadmap are dependent on priorities outside of the MHRA’s control. Current timelines may also be affected by the upcoming UK General Election, which is due to take place before 28 January next year.
You can find out more about the webinar content in this article.
MHRA shares advice on electrical aspects for clinical investigations
This month the MHRA shared “Electrical guidance for clinical investigations”. The document aims to provide basic supporting explanatory advice regarding devices that are electrically powered.
MHRA recommends that a clinical investigation application includes a separate document submitted for electrical safety and electromagnetic disturbances (EMD), which is the generic IEC term for both Electromagnetic Compatibility (EMC) and Electromagnetic Interference (EMI).
NMPA announces this year’s National Inspection Plan for medical devices
On 19 March, China’s NMPA announced its “2024 National Inspection Plan for Medical Devices”. The plan asks provincial NMPA offices and testing centres to conduct quality inspections based on mandatory standards and product technical requirements (PTRs).
Covering 66 medical devices and IVDs and including the inspection items referenced by mandatory standards for each product, the plan also lists the institutions and procedures for inspection, retesting, and appealing.
That concludes our March 2024 MedTech news roundup. Check back in April for more medical device news and updates.
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