Below is an overview of the June 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., new harmonized standards published and guidance on the change to the EC Rep symbol (to EU Rep).

EU Commission Updates

List of WET Devices Formally Updated

Well-established technologies (WET) devices are understood to have a long history on the market, stable and relatively simple designs, and well-understood safety and clinical performance profiles.

The above formal publication does not make any changes to the WET device list included in the draft versions published on 20 March 2026.

MDR Article 52(4) on Technical Documentation Assessment: cannulas, catheters, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, suspensory fixations and cinches

MDR Article 61(6)(b) on Clinical Investigations: cranial perforators, cranio-blades, catheter passers, patties and strips, magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, forceps, cannulas, atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, ventricular drains, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone tacks, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, tubal extraluminal ligation devices, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, dental veneers, suspensory fixations and cinches, reusable surgical instruments, springs for skull enlargement, guidewires, pressure wires, pacing wires and leads, snares, lead caps, fixation and connector tools, endovascular embolisation coils, embolisation particles, cables, shunts and internal defibrillation paddles

MDCG 2026-4 on Management of SS(C)Ps – June 18

MDCG 2026-4 is available: HERE

This new position paper advises on how changes to how SS(C)Ps will be uploaded to EUDAMED.

Current state: Notified Bodies upload them during the process of registering the manufacturer’s conformity assessment certificate.

Future state: MDCG 2019-9 – rev.1 will be revised to assign this responsibility to the manufacturer, i.e., the manufacturer will need to upload SS(C)Ps in EUDAMED.

Timing: EUDAMED will be updated to change the process, expected for October 2026.

Transition Period: Manufacturers of devices already on the market prior to 28 May 2026 should upload the SS(C)P as soon as possible, but no later than 27 February 2027.

Guidance for Regulation (EU) 2025/40 on Packaging and Packaging Waste

The guidance document is available: HERE

Regulation (EU) 2025/40 on packaging and packaging waste applies to certain medical devices. The guidance document notes:

“The objective of the labelling requirements provided for in Article 12(1) is to improve the sorting of packaging waste by consumers. Therefore, these requirements do not apply to the packaging of certain products, such as human or veterinary medicinal products, medical devices or in vitro diagnostic medical devices, that can only be used by professional end users in the course of their industrial or professional activities. The Regulation expressly excludes from this labelling obligation transport packaging, except for e-commerce packaging, and packaging that is subject to a deposit and return system. The specifications for the waste sorting labels will be established in an implementing act by 12. August 2026.

As regards the derogation provided for in Article 12(11), for medical devices and in vitro diagnostic medical devices there are no definitions for inner and outer packaging in Regulations (EU) 2017/745 and (EU) 2107/746. To ensure the derogation is correctly applied for those products, the reference to immediate packaging should be understood as referring to the packaging in contact with the device while the outer packaging should be understood as referring to the sales packaging of the device.

The packaging of the formats and materials that are exempted from the DfR criteria are also exempted from the ban on incineration and landfilling. The exemptions include packaging materials such as lightweight wood, cork, textile, rubber, ceramic, porcelain or wax. There are also exemptions for certain packaging applications, such as medical devices and transport of dangerous goods. The exempted packaging can be collected with the residual waste and be incinerated or landfilled. All other packaging that will have to comply with the design for recycling criteria will have to be separately collected and, in principle, recycled.”

New version of EUDAMED Deployed

Release notes are: HERE

The following features are now available:

Various system errors were also corrected. Please see the release notes for the full list, if you have been waiting on a particular fix.

Team-NB Updates

Paper on the MDR Certification Process Updated

The updated version is available: HERE

It was updated to add two new appendices, as well as to provide updated guidance throughout.

IVDR Application and Surveillance Transfer Agreement Template

The position paper is available: HERE

This new document is a template Agreement related to the transfer of formal IVDR applications, and of appropriate surveillance of legacy devices.

Paper on Support for Micro and Small Manufacturers

The position paper is available: HERE

It is in response to the Commission’s proposal to offer reduced fees, and other fee concessions, to micro and small manufacturers.

UK Updates

MHRA Provides Extra Month Grace Period to Pay Annual Fee

The announcement is: HERE

The MHRA’s fiscal year runs from April 1^st to March 31^st of each year; and the annual registration fees are due within 90 days of April 1, i.e., by June 30^th of each year.

However, the MHRA’s due date is extended this another month, making the annual fee due by 31 July 2026. Presumably, this is to help with any payment concerns, issues, or delays, as this is the first year of the MHRA’s new annual fee system. Fees must be paid directly to the MHRA by UK-based manufacturers, or for foreign manufacturers, by their UK Responsible Person.

Updates on AI Airlock

The MHRA published an overview of learnings from Phase 2 of the Air Airlock program: HERE

They also announced that they have secured continued funding through 2029.

Findings from the AI ‘Call for Evidence’

The ‘Call for Evidence’ outcome is available: HERE

This was the MHRA’s open consultation, soliciting feedback from industry about regulating AI in healthcare.

“Key themes included strong support for a regulatory approach which included ongoing monitoring of technologies for performance, safety and efficacy once they are put into practice; the importance of striking a balance between tight regulation and being able to move at pace so patients can benefit more quickly and public expectation that any technology is subject to rigorous safety checks, transparency, accountability and human oversight.”

‘Ask for a Regulatory Advice Meeting’ Guidance Updated

The webpage is available: HERE

Updates include the following:

Switzerland

Revision of the Swissmedic Fees Ordinance

The announcement is: HERE

In addition to the new fee for device registration, Swissmedic also confirmed that starting 1 July 2026, their hourly fee increased from CHF 200 to CHF 270.

Swissmedic charges for various activities, including certain market surveillance work.

Guidance Documents Updated

Swissmedic updated guidance documents, including the following:

They are all available: HERE