We simplify market access for medical devices

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.

European Commission

The Commission has developed draft guidelines on how to classify High-risk Artificial Intelligence Systems (HRAIS) under the EU AI Act. These three guidelines detail two main pathways for an AI system to be classified as high-risk:

• If an AI system is a product itself, or acts as a safety component within a product, that is governed by existing Union harmonisation legislation (such as medical devices).  (Article 6(1) and Annex I). This is of particular importance for medical devices and IVDs, since they do fall under this category when they are subject to Notified Body certification.
• If its intended use falls within sensitive areas where AI poses a significant risk to health, safety, or fundamental rights. (Article 6(2) and Annex III). This category is unlikely to apply to Class I medical devices or Class A IVDs, thus not really relevant for the MedTech industry. 

The draft guideline under Annex I of the AI Act addresses in detail the meaning of “safety component”, with examples that illustrate the difficulty in avoiding this definition for components of medical device software.

Swissmedic

Swissmedic held a webinar about product registration in swissdamed’s UDI module on Thursday, 28-May-2026. The slides can be found here. Some important points discussed in the webinar are:

• In case of parallel placing on the Swiss market of the “legacy” (MDD, AIMDD or IVDD) version and MDR/IVDR version of the same product, both must be registered in swissdamed. They may then be linked in swissdamed. If the “legacy” and MDR/IVDR device are already registered, the linking will be possible to be made with the online editor. If the devices are not registered yet, the link can be entered in the XML file. 
• Although not explicitly described anywhere, Swissmedic recommends to understand the requirement to immediately register a device subject to Vigilance reporting (MIR, FSCA, trend report) as applying not only to the initial report but also to follow-up and final reports of ongoing Vigilance cases.
• Swissmedic will charge swissdamed product registration fees, according to the new update to the Swiss Ordinance on fees for medical devices (FeeO-Swissmedic, SR 812.214.5). The fees will be charged to the manufacturers/SPP producers through invoicing to the Swiss Authorized Representatives (CH-REP), starting in January 2027.
  The fees in a given calendar year encompass:
  • Basic fee: CHF 200 for the first product registered by an Actor.
  • Unit fee: CHF 20 for each additional product. The maximum fee is CHF 10,000.
  • No fee for updates to a UDI-DI.
  • No fee if the device is marked as ‘No longer placed on the market’ as at 31.12.2026
  • More information is available from Swissmedic’s Registration fee webpage. 

• The function of importers linking the devices they import in swissdamed is planned go-live in autumn 2026.

After the function is made available, Swissmedic expects importers to complete the linking by 1 April 2027.

During this phase, Swissmedic will provide further information explaining the linking process for importers. Swissmedic assumes that the period from autumn 2026 to 1 April 2027 is sufficient to comply with the requirement for the first time. 

After that, all products, systems, and procedure packs placed on the Swiss market by importers must be linked. Any delay between placing the imported product on the market and linking it will no longer be tolerated from 1 April 2027.

The swissdamed Business Rules v4.0 is published. Some adaptations and new business rules are introduced. 

Team NB

A Position Paper of MDR Certification Process was published by Team NB. The primary purpose of the document is to harmonize the pre-application and application processes across different Notified Bodies. By clearly defining the minimum data required from manufacturers, the guidance aims to reduce incomplete submissions and allow NBs to process applications faster.

The document also includes comprehensive appendices that serve as checklists, detailing the exact master data and documentation manufacturers must submit during the pre-application and formal application phases

MedTech Europe

The position paper advocates for a more risk-proportionate regulatory framework during IVDR revision is published. 

• Emphasizing that most IVDs are non-invasive and fall into low-to-medium risk categories, the paper urges policymakers to reduce unnecessary certification burdens to help foster industry innovation.
• Calling for protecting a level-playing field by ensuring commercially available CE-marked devices remain the standard for patient safety, rather than allowing hospitals to freely use unregulated “in-house” tests.
• Strongly recommends aligning the “Orphan IVDs” definition with the EU’s standard rare disease threshold (5 in 10,000 people) to ensure that producing diagnostic tests for rare conditions remains economically viable.
• Categorising the European Commission’s recent proposals into elements they “Welcome” and elements they urge policymakers to “Strengthen”

European Commission

The EU Commission has published a welcome Implementing Reg. (EU) 2026/977 that harmonizes procedural requirements in conformity assessments by Notified Bodies under the EU MDR and IVDR.
It introduces:

• Maximum timelines:
  • Application review & contract: 30 days from receipt of a complete application
  • QMS auditing: 120 days from start of the audit programme to final review
  • Product verification (Technical Documentation): 90 days
  • Certification decision: 20 days after the final review
• Maximum number of timeline interruptions at each stage (e.g., only once during application review, and up to four times during QMS auditing or product verification). 
• Financial transparency: Notified Bodies must provide detailed quotations including estimated surveillance and unannounced audit costs. Manufacturers must be informed in advance of any cost increase exceeding 10%.
• Notified Bodies must publish annual reports by April 30th detailing median assessment durations and total costs.
• The re-certification process is streamlined to focus on changes, PMS data, and state-of-the-art updates, prohibiting the repetition of initial certification assessments.

Team NB

Team-NB has published a position paper on the clinical evaluation based on non-clinical data only (e.g., bench testing, in-silico, animal/cadaveric testing, or validated simulations), per EU MDR Article 61(10). The paper provides: 

• A set of helpful questions and examples to guide manufacturers in the potential applicability of Article 61(10), which revolves around: intended clinical performance and claims,  device/body interaction, and risk management. 
• Insights to Notified Body’s expectations on the clinical evaluation documentation under Article 61(10), as well as common deficiencies in the manufacturer’s justification, the analysis of the state-of-the-art, the approach to clinical evaluation and PMS/PMCF activities. 

Overall, this new position paper broadens the approach to Article 61(10), while simultaneously clarifying boundaries, and is particularly favorable for medical device software.

Swissmedic

Swissmedic has updated its guidance (Version 3.0) for submitting MIR reports, effective May 1st , 2026. The key changes are:

• New reference to “Selection of IMDRF AET Codes”, a guide for industry partners and healthcare providers.
• Explicitly prohibits using a “time range” for the incident date to cover multiple incidents in a single MIR.
• New symptoms arising after an initial report should be described in a follow-up report.
• Manufacturer and CH-REP details must align with the data registered in swissdamed.