We simplify market access for medical devices

Swissmedic

Information sheet on Procurement of medical devices in healthcare institutions has been updated to version 6.0. The updates focus on outlining device registration in swissdamed’s UDI module and how healthcare institutions can access the relevant data via the public view, facilitating checking of devices to be procured. 

Version 3.0 of swissdamed User Guide – Playground was published. The main updates are:

• Removed chapter 8: “Transfer UDIs by transferring a mandate” 
• Updated chapter 4: “Upload UDIs via XML” 
• Updated chapter 10: “Online editor – Create / manage UDIs manually”.

Handbook swissdamed User Guide UDI Devices Module has updated to version 3.0. Some chapters are added:

• chapter 9: “Machine-to-Machine (M2M) registration of devices”
• chapter 10: “Online editor – Create / manage UDIs manually” 
• chapter 11: “Master UDI-DI”

Version 4.0 of Information sheet Injectable products for wrinkle treatment was published. This document was fundamentally revised based on the findings from the SPA Filler 2024 / 2025. Product group “No clear information on use and residence time” added.

Swissmedic

Updated Handbook of swissdamed Actors module (v.3.0). The only changes are the adjustment of Actor admin and Mandate admin permissions in chapter 1.3.2, as follows:

• Clarifies the Actor admin’s permissions. It explicitly adds that an Actor admin can create new mandates and edit only the ‘Mandate valid from’ and ‘Mandate valid until’ dates.
• Clarifies and slightly restricts the Mandate admin’s permissions regarding dates. It specifies that a Mandate admin can edit mandates except the ‘Mandate valid from’ and ‘Mandate valid until’ dates. 

EU Commission

Implementing Dec. (EU) 2026/1231 updates the list of Harmonised Standards (HS) under the EU MDR with additions on:

• biological evaluation (EN ISO 10993-1:2025, EN ISO 10993-5:2009, EN ISO 10993-23:2021/A1:2025 and, EN ISO 10993-12:2021/A1:2025), 
• symbols (EN ISO 15223-1:2021/A1:2025), 
• medical electrical equipment (EN 60601-1:2006 and EN IEC 60601-2-83:2020/A11:2021 EN / IEC 60601-2-83:2020/A1:2025), 
• transfusion equipment for medical use (EN ISO 10993-17:2023/A1:2025 and EN ISO 1135-5:2025),
• ophthalmic optics (EN ISO 12870:2025 and EN ISO 14889:2025), 
• non-active surgical implants (EN ISO 14607:2025), 
• washer-disinfectors (EN ISO 15883-1:2025, EN ISO 15883-2:2025, EN ISO 15883-3:2025  and EN ISO 15883-7:2025), 
• prosthetics (EN ISO 22675:2025), and 
• sharps injury protection (EN ISO 23908:2025). 

Implementing Dec. (EU) 2026/1313 updates the list of Harmonised Standards (HS) under the IVDR with the addition of EN ISO 15223-1:2021/A1:2025 on symbols.

An Appendix to MDCG 2021-5 rev.1 has been published on the staggered approach for replacing the EC-REP symbol with the new EU-REP symbol, in compliance with EN ISO 15223-1:2021/A1:2025.
For a proportionate and resource efficient transition, a 5-year co-existence period is granted.

Compliance will be mandatory from 17 June 2031 for medical devices and IVDs. Until then, EC-REP and EU-REP symbols can co-exist at different levels of packaging. Because the transition is considered an editorial change in labelling, it does not need Notified Body approval.

A Position Paper in the form of MDCG 2026-4 has been published regarding the management of SSCP and SSP in EUDAMED after mandatory use. The key points are:

• Shift in uploading responsibility from Notified Bodies to manufacturers: Manufacturers shall upload both the master version and its translations, ensuring that the uploaded document is the exact version validated by the Notified Body. Notified Bodies shall simply indicate the validated SSCP/SSP in EUDAMED by ticking a box during certificate registration.
• Interim process: From the mandatory EUDAMED use date (i.e. 28-May-2026), until the new system features are live, Notified Bodies will continue uploading the master SSCP/SSPs alongside new or updated certificates, and manufacturers will remain responsible for managing the translations.
• Implementation timeline: The new functionality allowing manufacturers to upload the SSCP/SSPs will be rolled out in EUDAMED Playground in July 2026, and will be finally deployed to the Production environment in October 2026.
• Deadlines for existing devices: Because manufacturers cannot begin uploading SSCP/SSPs until October 2026, to align with the 12-month period Notified Bodies have to upload corresponding certificates, manufacturers must upload SSCP/SSPs for devices on the market no later than 27-Feb-2027.

The EU Commission is organizing a webinar on the upcoming EUDAMED SSCP/SSP functionality on 2-Jul-2026.

A new Guidance document for Regulation (EU) 2025/40 on packaging and packaging waste has been published. The main clarifications and exemptions relevant to medical devices and IVDs are:

• Qualification as packaging: Pre-filled intravenous (IV) bags and syringes do not fall under the definition of packaging. They are regulated as integral delivery devices and form an integral part of the medicinal product itself, rather than being a packaging component meant to be discarded.
• Labelling exemptions: The harmonised waste sorting labelling requirements, which are meant to help consumers sort waste, do not apply to the packaging of medical devices and IVDs that are strictly intended for professional use.
• Inner vs. Outer packaging derogations: To properly apply the labelling derogation (under Article 12(11)) the term “immediate packaging” refers to the packaging in direct contact with the device, while “outer packaging” refers to the sales packaging of the device. This clarification is provided because the EU MDR and IVDR do not formally define inner and outer packaging.
• Design for recycling and waste treatment: Packaging applications for medical devices and IVDs are exempted from the Design for Recycling (DfR) criteria. Because they are exempt from these criteria, they are also exempt from the general ban on the incineration and landfilling of recyclable packaging.

Team NB

A new Position Paper on initiatives for Micro- and Small Manufacturers has been published. The key initiatives proposals are:

• Systematically offering structured, non-binding dialogue during the conformity assessment process, at no additional cost. They also propose pre-submission interactions, similar to the US FDA’s Q-Submission programme, to clarify clinical, performance, and quality expectations early in their development pathways.
• To reduce the administrative burden of annual technical documentation reviews of well-assessed devices with no meaningful changes or safety signals, Notified Bodies should have the discretion to use targeted sampling instead of repetitive, full reassessments.
• Creation of structured EU or Member State-funded education frameworks and onboarding programmes to improve early technical documentation readiness. Additionally, they call for non-repayable funding mechanisms to offset substantial ecosystem costs, incl. clinical investigations, laboratory testing, and CROs.
• Because small manufacturers often rely on external consultants of varying quality, Team-NB proposes using structured dialogue to allow Notified Bodies to review and validate the regulatory approaches proposed by consultants at a high, non-binding level.
• Broader, risk-based implementation of remote or hybrid audits. For organizations with limited resources, stable portfolios, and a strong compliance record, this would reduce travel costs, administrative burdens, and logistical coordination.
• Active guidance on how to apply MDCG documents. They suggest closer collaboration across stakeholders to develop harmonized technical documentation templates, anonymized examples of high-quality submissions, and unified digitised submission frameworks.

Swissmedic

An updated information sheet on swissdamed M2M REST API Documentation v3.0 was published. Key change focus on Section 4.1 on OpenAPI specification link for the production environment.

Team NB

Team-NB published a position paper including a template agreement for IVDR Notified Body Transfers. To help manufacturers maintain their IVDR Article 110 (3e) transitional benefits when changing NBs. Key takeaways are:

• Seamless Regulatory Continuity: The agreement allows manufacturers to simultaneously terminate their contract with an Outgoing NB and sign with an Incoming NB on an agreed “Transfer Date”. This simultaneous action ensures the legal conditions of the IVDR transitional period are maintained.
• Legacy Device Surveillance: For devices still under valid IVDD certificates, the Incoming NB completely takes over “appropriate surveillance” (including QMS audits, vigilance, and authority communications) starting on the Transfer Date.
• Clear Split of Liability: The Outgoing NB remains strictly liable for all conformity assessments and surveillance actions taken prior to the Transfer Date. The Incoming NB assumes full responsibility from the Transfer Date onward.
• Mandatory Transparency: A safe transfer requires full disclosure. The manufacturer and the Outgoing NB must provide the Incoming NB with technical documentation, previous audit reports, vigilance cases, and records of any open non-conformities.
• Traceability and Labeling: The agreement includes specific provisions for transitioning the NB identification number on product labeling. Manufacturers must carefully document this change for each device catalogue number, tying it to a specific “last serial or lot number” produced under the Outgoing NB’s surveillance.