Below is an overview of the April 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., three new harmonized standards published.

EU Commission/Competent Authority

Article 10a Decision Tree Published

A task force under the Competent Authorities for Medical Devices (CAMD) developed a new Article 10a Decision Tree: HERE

Its purpose is to complete the Commissions Q&A on the ‘Obligation to inform in case of interruption or discontinuation of supply’. The Q&A was also updated, to reference the new Decision Tree.

Casus has updated its free Article 10a reporting procedure accordingly.

EMDN Version History Published

As noted in January, the 2026 updated EMDN codes were published into EUDAMED.

The Commission has now published the full version history, the annual revision change log, and summary of EMDN 2025 submissions and outcome. They are available: HERE

EUDAMED Production V2.25.3 Release Notes

Version 2.25.3 of EUDAMED was deployed mid-April. Full release notes are available: HERE

One notable change is that EUDAMED will no longer display the name or contact details for inactive Persons Responsible for Regulatory Compliance (PRRCs) in the versioning/historical records. This is to ensure compliance with GDPR requirements. Note that the supervising entities will still have access to this information.

Borderline Device Manual Version 5 Published

It is available: HERE

It was updated to include decisions on the following products:

New Manufacturer Incident Report XSD Files and XSL Files

The Commission published new XSD and XSL files: HERE

These are to support XML submissions of the new Manufacturer Incident Report (MIR) form v7.3.1, which became mandatory as of 1 May 2026. This is not applicable to manufacturers who submit their MIR forms by email.

National Requirements for Clinical Investigations and Performance Studies

The Commission published an update to member-state specific national requirements for clinical investigations and performance studies: HERE

MDCG Working Group Feb 2026 Meeting Minutes

The MDCG Working Group published the minutes from its 10-11 February 2026 meetings:

Some items of note include:

Common specifications (CS): work has resumed, one for cardiac stents, and one for breast implants.

EUDAMED: functionality being developed to notify EU ARs of newly submitted and registered Basic UDI-DIs linked to them.

MDSAP: the MDCG task force on MDSAP had a kick-off meeting on 22 January 2026. Revision of the MDSAP to MDR/IVDR mapping will be conducted in close coordination with NBCG-Med, with aim to finalize it by end of Q2 2026. This mapping is to be the basis for next steps, including work on the Single Audit Report, as well as EU input to the MDSAP audit approach.

MDCG Annex XVI Working Group March 2026 Meeting Minutes

The MDCG Annex XVI sub-group published the minutes from its 19 March 2026 meeting: HERE

Annex XVI devices are those without a medical purpose, but act similar to medical devices in terms of function and risk profile, e.g., laser/IPL equipment intended for hair removal or skin resurfacing.

Some notable takeaways include:

Pilot Program to Support Breakthrough Devices

An update on the pilot program to support breakthrough (BtX) devices has been published: HERE

It launched 28 April 2026, and is set to run in three phases until 2027 (subject to available resources).

Applications for the first phase are open until 22 May 2026, and eligible devices include:

Five applications will be selected, with priority given to cardiovascular devices and devices intended for children.

Fimea Publishes Research Plan Template to Support Clinical Device Studies

Finland Competent Authority Fimea has published a clinical investigation plan (CIP) template: HERE

It is designed to support investigators and organizations conducting clinical investigations of medical devices, and helps ensure that investigations meet the essential requirements of both the EU Medical Devices Regulation (MDR 2017/745) and Finnish national legislation.

Austrian CA Publishes New Registration Handbook

The Austrian Competent Authority published a new registration handbook: HERE

It is intended for 1) manufacturers of Custom-Made Devices (CMDs), 2) medical device retailers, and 3) testing, inspection, and certification bodies. The handbook guides users through the registration process, providing step-by-step instructions.

NoBoCap Training Course

NoBoCap has a new short course on the EU MDR/IVDR & FDA QMSR available: HERE

It takes place online, on 7 May 2026, from 11am-11:15am Central European Time.

NoBoCap (Notified Body Increased Capacity) is an EU-funded project designed to speed up medical device approvals by strengthening the capacity of Notified Bodies (NBs) and training professionals on EU MDR/IVDR regulations.

Team Notified Body Updates

Position Paper on MDR Tech File Best Practices Updated

The updated position paper is available: HERE

It includes new sections, such as ‘Common Pitfalls in Pre-Clinical and Clinical Data’.

New Position Paper on Article 61(10) Applicability

The paper is available: HERE

It provides guidance on what Notified Bodies look for while reviewing Article 61(10) justification, and “best practice for preparing a robust justification for its use”.

As part of this, the paper includes a series of questions that “may be useful for the manufacturer to consider when documenting…the justification”.

Below are the questions related to the Intended Clinical Performance and Claims, as an example.

Question/Consideration	Team-NB Guidance
Clearly describe the role of the device within the clinical setting	In general, the less integral to the success of the diagnostic or therapeutic intervention, the more likely Article 61(10) will be applicable. For example, Article 61(10) may be more applicable to an accessory to a medical device which does not impact the achievement of health outcomes for the patient
How does the device achieve its intended purpose?	The less that individual patient characteristics influence the successful achievement of a device’s intended purpose, the more likely Article 61(10) will be applicable
How does the device contribute to a positive impact on the health of an individual or a positive impact on patient management or public health and how will that impact be demonstrated?	The greater the potential impact on health outcomes, the less likely that Article 61(10) will be applicable
What actions are triggered by the information provided by the device and how soon will the information be acted on?	Article 61(10) is more likely to be applicable to a device which does not trigger an immediate patient treatment decision or action
How is it demonstrated that the device performs favorably when compared to state of the art?	Article 61(10) is unlikely to be accepted if the state of the art safety and performance endpoints are defined by clinical data
Are there any explicit clinical claims (e.g., “This device will reduce pain”) or implicit clinical claims that can only be confirmed by clinical data? Implicit claims are claims that are not explicitly stated by the manufacturer, but are obvious from the state of the art, e.g. a manufacturer only states that a TENS (Transcutaneous Electrical Nerve Stimulation) device is intended to create electric pulses, but it is obvious from the state of art that this would always be used for pain control.	If “Yes”, Article 61(10) is not applicable as clinical data is required to support clinical claims
Are the results of the non-clinical performance testing representative of all possible disease states, scenarios where the device is used, tissue types, patient population, users, etc. that the device is likely to interact with?	If “Yes”, Article 61(10) becomes more applicable

Team NB Partners with MedTech Label EU Project

Team NB announces participation in MedTechLabel: HERE

This is a European project “aiming to develop a unified digital labelling framework for medical devices”.

Feedback on MDR/IVDR Reform

Team NB published feedback on the MDR/IVDR reform: HERE

This was in response to the Commission’s ‘Have your say’ initiative, to collect stakeholder feedback on the reform proposal.

Team NB raised concerns regarding reduction of Notified Body involvement across certification and surveillance activities (such as removal of CE certificate expiration dates) and feel the MDR/IVDR reform reduces regulatory oversight to a level below the old Directives (MDD/AIMDD/IVDD). Further, their position is that “there is no notified body “fee problem” that requires solving: the Commissions’ proposal does not present a sufficiently detailed impact analysis or substantive proportionality argumentation, to support the position taken in proposed Article 50.”

Code of Conduct Updated

Team NB published an updated Code of Conduct: HERE

It was updated to align the time to review software between the MDR and IVDR, and some minor formatting changes to the table of contents.

UK Updates

CFS Guide Updated

Updated guidance is available: HERE

It was updated to include minor clarifications, e.g., Certificates of Free Sale can only be ordered for manufacturers with a registration status of ‘Registered’. If the account status is ‘Suspended’, they must first rectify the suspension.

Registration Webpage and Guidance Updated

MHRA registration guidance webpage updated: HERE

It was updated to reflect the new annual registration fee, which went into effect on 1 April 2026.

MHRA Expands AI Airlock Program

The MHRA will introduce a new AI Airlock Phase 3: HERE

The AI Airlock pilot program aims to use real-world products to help guide future AI guidance and policy.

Clinical Investigations Webpage Updated

The MHRA guidance webpage was updated: HERE

The Pilot section was updated; it notes that the fee waiver programme for SMEs has been extended until 5 April 2027, or until such time that all fee waivers have been granted.

Switzerland Updates

Guidance on Medical Device Software Updated

Swissmedic updated its guidance on software devices: HERE

It underwent significant revision and reformatting, and includes reference to new MDCG guidance since its last revision.

New Edition of ISO 14155:2026

Swissmedic notes the new edition of ISO 14155:2026 has been made available: HERE

It was made available by ISO with redlines to show the changes made from the previous edition.

“Amongst the different changes introduced in the new edition, there are updates related to safety management, including provisions for planning, ongoing safety surveillance, the assessment of safety events and measures to be taken in the event of safety issues arising during a clinical investigation. Swissmedic therefore welcomes the new standard and encourages its use.”

Manufacturer Incident Report (MIR) Form Updated

Swissmedic has published the updated EU MIR form for use in Switzerland: HERE

IMDRF Updates

Singapore March 2026 Meeting

The IMDRF published its meeting outcome statement: HERE

Scroll down for all the individual slide decks.

A few items of note:

New Consultation on Draft AI Life Cycle Management Guidance

The IMDRF opened a new public consultation: HERE

This is related to the draft ‘Technical Framework for Artificial Intelligence Life Cycle Management’.

Interested parties have until 10 July 2026 to provide feedback.