The week of 19–25 October 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors.
This edition covers the UK Government’s decision to recognise CE-marked medical devices indefinitely in Great Britain, FDA’s hypothetical case examples for Predetermined Change Control Plans, and three Team-NB publications on notified-body practices, digitalisation and MDR/IVDR reform. The week also included two CECP expert panel opinions and an updated FDA import alert affecting certain Olympus medical devices.
In this issue
- UK Government confirms indefinite recognition of CE-marked medical devices in Great Britain
- FDA publishes hypothetical PCCP case examples for novel medical devices
- Team-NB updates Code of Conduct and reports on DIGICAP and MDR/IVDR campaign
- EMA publishes two CECP expert panel opinions on cardiac and cervical therapy devices
- FDA updates import alert for certain Olympus medical devices manufactured in Japan
UK Government Confirms Indefinite Recognition of CE-Marked Medical Devices in Great Britain
On 21 October 2026, the UK Government confirmed its decision to recognise CE-marked medical devices and IVDs compliant with the EU MDR and IVDR indefinitely in Great Britain.
The Government also intends to align recognition of eligible devices certified under the EU Medical Devices Directive (MDD) with the applicable EU transitional arrangements. This is distinct from the indefinite recognition of devices compliant with the MDR and IVDR.
The UKCA marking will remain available as the domestic conformity assessment route for the Great Britain market. Once the announced policy is implemented, eligible CE-marked devices will not require an additional UKCA conformity assessment solely to maintain market access beyond the current recognition periods.
Applicable domestic requirements, including MHRA registration, appointment of a UK Responsible Person where required, and post-market surveillance obligations, will continue to apply.
The decision still requires legislative amendments, which the Government intends to introduce before 30 June 2028, subject to parliamentary approval. Until those changes enter into force, the current Great Britain market-access arrangements remain applicable.
The decision provides greater long-term certainty for market-access planning and aims to avoid duplicate conformity assessments for manufacturers supplying both the EU and Great Britain markets.
Read the dedicated insight: UK confirms indefinite recognition of CE-marked medical devices: what happens to UKCA?
Source: MHRA / UK Government
References: Government confirms indefinite recognition of CE marked medical devices; Consultation outcome and Government response, MHRA / UK Government
FDA Publishes Hypothetical PCCP Case Examples for Novel Medical Devices
On 20 October 2026, FDA published hypothetical case examples illustrating how Predetermined Change Control Plans (PCCPs) could support modifications to novel medical devices.
The resource presents two scenarios: a hospital-localised sepsis alert system and continuously learning cardiac arrhythmia detection software.
The first example describes the adaptation of a machine-learning model to individual hospital environments using site-specific data, with manufacturer review and approval before deployment.
Second example illustrates automated, periodic model retraining and deployment within predefined limits. The proposed controls include automated validation, blocking deployment when acceptance criteria are not met, maintaining audit trails and conducting post-deployment monitoring.
FDA emphasises that the examples are illustrative and do not represent complete PCCPs. The modifications described assume that changes remain within the scope of an authorised plan and satisfy its predefined conditions.
The examples illustrate how PCCP principles may be applied to model adaptation, validation, deployment and monitoring, including controls for automatically implemented software updates.
Source: FDA
Reference: Novel Medical Devices with Predetermined Change Control Plans: Hypothetical Case Examples, FDA
Team-NB Updates Code of Conduct and Reports on DIGICAP and MDR/IVDR Campaign
Between 19 and 21 October 2026, Team-NB published three updates addressing notified-body practices, digitalisation and stakeholder engagement on EU medical device regulatory reform.
On 19 October, Team-NB published Version 5.3 of its Code of Conduct. The revised code introduces a requirement for Team-NB members to establish a quality management system (QMS) process for investigating suspected certificate falsification or misuse. The process covers evidence preservation, proportionate corrective or legal action, and notification of relevant parties where appropriate, while respecting confidentiality and legal requirements.
On 20 October, Team-NB published an update on DIGICAP — Digitalizing the Conformity Assessment Process. The EU-funded initiative aims to support a more data-driven conformity assessment process through structured, machine-readable dossiers and the reuse of information across notified-body tools, EUDAMED and regulatory technology software.
On 21 October, Team-NB published a report on its MDR/IVDR LinkedIn Safety Campaign. The document summarises the association’s communication activities concerning MDR/IVDR reform, including stakeholder engagement and discussions on patient safety, innovation and confidence in the regulatory framework. It reports advocacy and communication activities rather than introducing a new technical regulatory position.
These publications highlight the association’s priorities in certificate integrity, conformity assessment digitalisation and stakeholder engagement on MDR/IVDR reform. They do not introduce new legal requirements under the MDR or IVDR.
Source: Team-NB
References: Code of Conduct — Version 5.3; DIGICAP — Digitalizing the Conformity Assessment Process; MDR/IVDR revisions — Team-NB LinkedIn Safety Campaign, Team-NB
EMA Publishes Two CECP Expert Panel Opinions on Cardiac and Cervical Therapy Devices
On 21 October 2026, the European Medicines Agency published two expert panel opinions under the Clinical Evaluation Consultation Procedure (CECP), concerning a transcatheter cardiac shunt system and a device used for cervical photodynamic therapy.
For the cardiac shunt system, the expert panel acknowledged promising clinical findings while emphasising the preliminary nature of the available benefit-risk assessment. The panel highlighted the need for further clinical evidence and post-market clinical follow-up (PMCF).
For the cervical photodynamic therapy device, the expert panel identified limitations concerning the definition of the intended patient population, comparative clinical evidence and prospective monitoring of longer-term outcomes.
The underlying scientific opinions are dated 25 November 2025 and 12 May 2026, respectively. The development reported during the week was their publication, rather than the completion of the original assessments.
CECP opinions form part of the conformity assessment process for certain high-risk medical devices under the MDR. They represent independent expert assessments and do not constitute EMA marketing approvals or establish the final certification status of the devices.
The two opinions provide examples of how MDR expert panels assess clinical evidence, intended purpose, benefit-risk considerations and PMCF plans for high-risk medical devices.
Source: EMA / Medical Device Expert Panels
References: Cardiac device — CECP expert opinion; Cervical therapy device — CECP expert opinion; EMA — Expert panel opinions, EMA
FDA Updates Import Alert for Certain Olympus Medical Devices Manufactured in Japan
On 20 October 2026, FDA updated its communication concerning an existing import alert affecting certain Olympus medical devices manufactured in Japan.
The update expands the list of affected devices to include additional endoscopic models, certain enteroscopes and ingestible gastrointestinal capsule imaging systems.
The action follows ongoing FDA concerns regarding outstanding quality system regulation violations. It extends an existing import alert rather than imposing a general restriction on all Olympus products.
FDA explains that devices covered by the import alert that are already in use may continue to be used if they are not experiencing problems.
Health care providers should follow the applicable labelling, reprocessing and maintenance instructions, together with any relevant manufacturer recall notifications.
The Agency also advises providers to review the specific models and device identifiers covered by the alert and to discuss the benefits and risks of procedures involving these devices with patients.
The update is relevant to supplier oversight, procurement and continuity-of-supply planning, particularly for healthcare organisations using the affected Olympus devices.
Source: FDA
Reference: Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan — Letter to Health Care Providers, FDA
Share this article
Subscribe to MDN
Subscribers receive each new issue by email every Monday, one week before it is published on the website.
Latest issues
MDN Archive and News Collection
Browse all published MDN issues in the MDN Archive or search individual news items in the News Collection.