The week of 26 October–1 November 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
This edition covers revised MDCG guidance on managing summaries of safety and clinical performance (SSCPs) and summaries of safety and performance (SSPs) in EUDAMED, FDA’s proposed electronic submission framework for Investigational Device Exemption (IDE) applications, and an Australian consultation on digital mental health tools. The week also included updated EU HTA procedures for Joint Scientific Consultations and information from Swissmedic on swissdamed registration fees and invoicing.
In this issue
- MDCG revises position paper on SS(C)P management in EUDAMED after mandatory use
- FDA issues draft guidance on electronic submission template for IDE applications
- TGA consults on the exclusion for certain digital mental health tools
- EU HTA updates Joint Scientific Consultation procedures to include watcher role
- Swissmedic updates information on swissdamed registration fees and invoicing
MDCG Revises Position Paper on SS(C)P Management in EUDAMED After Mandatory Use
On 30 October 2026, the European Commission published MDCG 2026-4 rev.1, an updated position paper on the management of summaries of safety and clinical performance (SSCPs) and summaries of safety and performance (SSPs) in EUDAMED following the start of mandatory use.
The document describes the planned transfer of responsibility for uploading these summaries from notified bodies to manufacturers.
Under the revised workflow, manufacturers will upload the validated master documents and relevant translations, while notified bodies will identify the validated summaries when registering or linking the corresponding certificates in EUDAMED.
Until the new functionality becomes available in the EUDAMED production environment, currently planned for December 2026, notified bodies must continue uploading the master SSCPs and SSPs when registering new certificates or updating existing ones.
For devices placed on the market before mandatory use of the UDI/Devices module, manufacturers should upload the summaries as soon as possible and no later than 27 March 2027.
This timeline concerns SSCP and SSP uploads and does not represent a general extension of device registration deadlines.
The position paper provides practical, non-binding direction for coordinating document uploads and certificate registration as manufacturers and notified bodies prepare for the revised EUDAMED workflow.
Source: Medical Device Coordination Group (MDCG)
Reference: MDCG 2026-4 rev.1 — Management of SS(C)P in EUDAMED after mandatory use, MDCG
FDA Issues Draft Guidance on Electronic Submission Template for IDE Applications
On 28 October 2026, FDA issued the draft guidance Electronic Submission Template for Investigational Device Exemption (IDE) Applications.
The document introduces sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) to the electronic submission resources and templates currently available, including eSTAR.
The draft describes a proposed transition towards mandatory electronic submissions for IDE applications within its scope.
Sponsors may currently use eSTAR voluntarily. The proposed mandatory electronic submission requirements would take effect only after publication of final guidance and a transition period of at least one year.
The document is explicitly designated Draft — Not for Implementation, and the deadline for submitting comments is 28 December 2026.
This draft is relevant to sponsors planning clinical investigations in the United States, who can begin assessing how eSTAR may be incorporated into their IDE submission processes. It does not establish an immediate new electronic filing obligation.
Source: FDA
Reference: Electronic Submission Template for Investigational Device Exemption (IDE) Applications, FDA
TGA Consults on the Exclusion for Certain Digital Mental Health Tools
On 26 October 2026, Australia’s Therapeutic Goods Administration (TGA) opened a public consultation on whether the existing regulatory exclusion for certain digital mental health tools (DMHTs) should be retained, modified or removed.
These tools include applications, websites and chatbots offering mental health assessment, therapy or self-management support.
Although many digital mental health tools are already regulated as medical devices in Australia, certain products remain excluded under provisions introduced in 2021.
TGA notes that these technologies have become increasingly diverse and complex, including through the use of artificial intelligence.
This development raises questions about whether the current exclusion remains appropriate for the functions and risk profiles of certain products.
The consultation is open until 7 December 2026.
The outcome may inform future changes to the regulatory treatment of digital mental health tools, potentially bringing some currently excluded products within Australia’s medical device regulatory framework. No changes to the existing exclusion have yet been adopted.
Source: Therapeutic Goods Administration
Reference: Consultation: Reviewing the exclusion for certain digital mental health tools, TGA
EU HTA Updates Joint Scientific Consultation Procedures to Include Watcher Role
On 26 October 2026, the European Commission published updated procedural guidance for Joint Scientific Consultations (JSCs) concerning medical devices and in vitro diagnostic medical devices.
The updated document was adopted by the HTA Coordination Group on 22 October 2026.
The revision introduces an optional watcher role, allowing representatives of the JSC subgroup to attend meetings between the assessor and co-assessor for learning and capacity-building purposes.
Watchers are not expected to provide input during these meetings.
Joint Scientific Consultations provide health technology developers with scientific consultation during the planning of clinical evidence generation, including evidence that may subsequently be relevant to Joint Clinical Assessments.
The revision supports the operational development of the EU HTA consultation process. It is a procedural update and does not replace MDR or IVDR conformity assessment procedures or determine national reimbursement decisions.
Source: European Commission / HTA Coordination Group
Reference: Procedural Guidance for Joint Scientific Consultations on Medical Devices and IVDs, European Commission
Swissmedic Updates Information on swissdamed Registration Fees and Invoicing
Swissmedic updated its information on swissdamed medical device registration fees and invoicing, including an information sheet dated 27 October 2026.
The registration fee system has been applicable since 1 July 2026, with charges calculated on the basis of UDI-DI registrations.
The fees are structured as follows:
- CHF 200 for the first UDI-DI registered in a calendar year.
- CHF 20 for each additional UDI-DI registered in the same calendar year.
- A maximum of CHF 10,000 per calendar year for each manufacturer or person assembling systems or procedure packs.
Initial billing will begin in January 2027, covering UDI-DIs registered up to and including 31 December 2026 that have the status On the market on that date.
Updates to existing registered product data are free of charge.
Fees are calculated for each manufacturer or person assembling systems or procedure packs. For foreign manufacturers, invoices are issued to their Swiss authorised representatives.
Swissmedic also provides an Invoice Dashboard through which authorised users can manage billing addresses, purchase order numbers and invoice delivery preferences.
The update clarifies the practical application of an existing registration fee system rather than introducing new charges. Manufacturers and Swiss authorised representatives can use this information to review their registration status and invoicing arrangements ahead of year-end.
Source: Swissmedic
References: Registration fee — swissdamed; Medical device registration fee — Information sheet, 27 October 2026, Swissmedic
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