The week of 29 June–5 July 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
The main developments included new EU delegated acts on well-established technologies under the MDR, Team-NB proposals on risk-adaptive surveillance, the start of mandatory device registration in Switzerland’s swissdamed database, an MHRA borderline update, and the expansion of FDA’s TAP Pilot.
European Commission Publishes Delegated Acts on Well-Established Technologies under the MDR
The European Commission published two delegated acts concerning well-established technologies, or WET, under Regulation (EU) 2017/745 on medical devices.
Regulations amend MDR provisions concerning clinical investigation exemptions for certain implantable and class III devices, and technical documentation assessment for certain class IIb implantable devices.
The acts were published in the Official Journal of the European Union on 29 June 2026 and will enter into force 20 days after publication.
The delegated acts may reduce certain clinical investigation and technical documentation assessment requirements for selected device categories recognised as well-established technologies.
Source: European Commission / Official Journal of the European Union
Reference: Delegated acts on well-established technologies published; Regulations (EU) 2026/1451 and (EU) 2026/1359
Team-NB Proposes Risk-Adaptive Surveillance Systems under the MDR and IVDR
On 1 July 2026, Team-NB published two complementary position papers proposing details for the implementation of risk-adaptive surveillance by notified bodies under the MDR and IVDR.
The papers address how surveillance measures for devices and manufacturers could be adapted according to risk considerations.
They are presented as Team-NB proposals and do not constitute official EU regulatory guidance.
The papers provide notified-body sector input into ongoing discussions on proportionality and surveillance under the MDR and IVDR.
Source: Team-NB
Reference: MDR and IVDR proposals for risk-adaptive surveillance systems, Team-NB, 1 July 2026
Swissmedic Confirms Mandatory Device Registration in swissdamed from 1 July 2026
Swissmedic confirmed that mandatory registration in swissdamed applies to medical devices and IVDs from 1 July 2026.
The national database replaces existing notification procedures for certain devices, systems and procedure packs, with a transition period lasting until 31 December 2026.
No transition period applies where a serious incident, field safety corrective action or trend must be reported to Swissmedic.
The update marks the start of mandatory Swiss device registration and introduces a national database obligation for affected devices and operators.
Source: Swissmedic
Reference: swissdamed mandatory registration update, Swissmedic, 1 July 2026
MHRA Updates Great Britain Guidance on Borderlines with Medical Devices
On 29 June 2026, the Medicines and Healthcare products Regulatory Agency updated its guidance on “Borderlines with medical devices and other products in Great Britain.”
The update clarifies that alcohol-only pre-injection swabs and wipes are considered medical devices, while pre-injection swabs and wipes containing antimicrobial substances such as chlorhexidine, cetrimide or iodine are considered medicinal products.
The update provides a specific example of how MHRA distinguishes between medical devices and medicinal products in Great Britain.
Source: MHRA
Reference: Borderline products: medical devices and other products, MHRA, updated 29 June 2026
FDA Expands TAP Pilot across All Offices of Health Technologies
On 1 July 2026, the U.S. Food and Drug Administration updated its Total Product Life Cycle Advisory Program page.
According to the update, as of 1 July 2026, 133 devices were enrolled in the TAP Pilot.
FDA also stated that TAP expanded to accept enrollment requests across all Offices of Health Technologies for eligible Breakthrough-designated and Safer Technologies Program devices.
The update broadens access to a CDRH pilot program focused on earlier engagement for selected innovative medical devices.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Total Product Life Cycle Advisory Program (TAP), FDA, updated 1 July 2026
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