The week of 31 August–6 September 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
The main developments included proposed UK legislative changes supporting a possible future medical-device licensing regime, the opening of the next phase of EMA’s breakthrough-device pilot, the launch of an EU-funded project to digitalise MDR/IVDR conformity assessment, a high-severity FDA spinal cord stimulator recall and new MHRA safety guidance on filtration during parenteral nutrition.
In this issue
- MHRA announces regulatory reform amendments in the Government’s Health Bill
- EMA opens Phase Ib of the breakthrough medical-device pilot
- EU-funded DIGICAP project launches for MDR/IVDR conformity assessment digitalisation
- FDA identifies Boston Scientific Infinion CX Lead recall as most serious type
- MHRA advises use of filters during parenteral nutrition administration
MHRA Announces Regulatory Reform Amendments in the Government’s Health Bill
On 1 September 2026, MHRA announced that the UK Government had tabled amendments to the Health Bill concerning medicines and medical devices.
The proposals include information-sharing powers, measures intended to make medicines and medical-device legislation easier to update, and enabling powers for the future development of a medical-device licensing regime.
Under the model being explored, devices placed on the Great Britain market through a domestic route could in future require an MHRA-issued licence.
MHRA stressed that the amendments do not introduce an immediate change to the current framework. The existing UKCA arrangements remain in place while any future licensing model would require further policy development and parliamentary scrutiny.
Northern Ireland continues to apply the EU MDR and IVDR under the Windsor Framework.
The amendments create a legislative basis for potentially significant future changes to the regulatory oversight of medical devices placed on the Great Britain market.
Source: MHRA
Reference: MHRA regulatory reform amendments tabled in Government’s Health Bill, MHRA
EMA Opens Phase Ib of Breakthrough Medical-Device Pilot
On 1 September 2026, Phase Ib of EMA’s pilot programme supporting breakthrough medical devices opened for submissions.
This phase covers Class III medical devices and Class IIb active devices intended to administer or remove medicinal products from the body.
Medical-device expert panels, supported by relevant national competent authorities, can assess breakthrough status and provide advice to eligible devices in line with MDCG 2025-9.
Applications falling within the scope of the pilot can be submitted through the dedicated EMA portal.
The pilot provides expert-panel support to manufacturers of breakthrough medical devices and to notified bodies.
The opening creates a new operational access point to EU expert-panel support for eligible high-risk medical devices.
Source: EMA
Reference: Expert panel support for breakthrough medical devices: pilot programme, EMA
EU-Funded DIGICAP Project Launches for MDR/IVDR Conformity Assessment Digitalisation
On 1 September 2026, the DIGICAP project — DIGItalisation of the Conformity Assessment Process — officially launched under the EU Horizon Europe programme.
The three-year project aims to support the harmonisation and digitalisation of conformity assessment procedures under the MDR and IVDR.
The project is intended to move the conformity assessment process from fragmented document-based exchanges towards structured, machine-readable data and standardised exchange formats.
Coordinated by Team-NB, the consortium brings together 19 European partners, including notified-body representatives, MedTech Europe, research organisations and regulatory and technical experts.
The project has received approximately €4 million in EU funding and will develop an open-source framework, test it through pilot activities and produce a roadmap for wider implementation.
DIGICAP addresses conformity-assessment efficiency and interoperability across the MDR/IVDR ecosystem, although it does not itself change EU regulatory requirements.
Source: Team-NB / European Commission CORDIS
Reference: DIGItalisation of the Conformity Assessment Process, DIGICAP, Team-NB / European Commission CORDIS
FDA Identifies Boston Scientific Infinion CX Lead Recall as Most Serious Type
On 3 September 2026, FDA posted a recall involving unused Boston Scientific Infinion CX Leads used with spinal cord stimulation systems and identified the action as the most serious type of recall.
Boston Scientific reported that mechanical stress at the lead anchor site may result in high impedance measurements or lead fractures.
The issue may cause inadequate stimulation and require additional intervention, including lead explant or replacement.
The recall concerns unused products and does not affect devices already implanted.
As of 27 May 2026, Boston Scientific had reported 1,081 serious injuries and no deaths associated with the issue.
The manufacturer’s customer communication was originally issued on 17 June 2026.
The recall involves an implanted neurostimulation system component and a substantial number of reported serious injuries.
Source: FDA / CDRH
Reference: Spinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead, FDA
MHRA Advises Use of Filters during Parenteral Nutrition Administration
On 2 September 2026, MHRA issued Device Safety Information DSI/2026/011 concerning the use of filters during administration of parenteral nutrition in all care settings.
MHRA said administration without a filter had been associated with adverse incidents, including an embolism with a fatal outcome.
Agency’s review identified inconsistencies in existing guidance and states that filtration provides an additional risk-minimisation measure against contamination risks such as air infusion, particulate matter and precipitation events.
The communication specifies a maximum filter pore size of 1.2 μm for parenteral nutrition solutions and identifies 0.2 μm filtration as good practice for aqueous or lipid-free solutions.
The notice applies across care settings and addresses a device-related safety measure associated with potentially serious complications during parenteral nutrition administration.
Source: MHRA
Reference: Filters should be used during the administration of Parenteral Nutrition for patients in all care settings, DSI/2026/011, MHRA
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