Commission Publishes Updated Links to Notified Body Fee Lists
20 July 2026
August Updates: New EUDAMED Functionality, New IMDRF Guidance, and More
2 September 2026Below is an overview of the July 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., updated list of NB fee lists.
Europe
New MDCG 2026-5 Position Paper
The MDCG published a new position paper on UDI assignment between manufacturers and distributors: HERE
It notes:
“The provisions of the MDR and IVDR, and the indications provided by the EU UDI Helpdesk, should not be interpreted that any other economic actors (authorised representatives, distributors, importers) than the manufacturer may assign UDIs to devices. The manufacturer, as indicated on the label of the device and the device documentation, is the only entity which can assign UDIs to the device intended to be placed on the EU market (and receive codes from the EU UDI issuing entities, being the codes linked to the manufacturer) and the only entity which can register the device in Eudamed.”
MDR/IVDR Reform Progress
The Commission’s proposal continues through the review channels:
- Parliament Committee draft report on MDR/IVDR: HERE
- Opinion of the European Economic and Social Committee on MDR/IVDR reform proposal: HERE
Webinar about new SS(C)P Functionality in EUDAMED
The Commission published the recording it gave live on 2 July 2026: HERE
The webinar describes the process manufacturers must take to upload Summary of Safety (and Clinical) Performance (SS(C)P) documents into EUDAMED. SSPs are required for Class C and D IVDs, and SSCPs are required for Class III and implantable devices.
Commission on NB Applications & Monitoring
A report was published regarding Conformity Assessment Bodies/Notified Bodies at each stage of their designation process, and is available: HERE
Reports are available per member state, on the annual monitoring and onsite activities regarding Notified Bodies: HERE
Study on the Monitoring of Availability Devices
An updated study monitoring the availability of medical devices in Europe is available: HERE
Some points of interest from the study results:
- MDR applications may have plateaued. Total filings fell slightly to ~32,900, while certificates climbed to 18,010.
- Submission quality is still a problem. Only 14 of 52 MDR notified bodies say more than half of submissions arrive complete. That number has barely moved across 11 survey rounds.
- EURL batch testing data provided. 841 IVDR Class D batches tested by EURLs since October 2024, almost all in the hepatitis category. Respiratory, bacterial, and herpes categories show zero EURL-tested batches.
Team NB
New Position Paper
Team NB’s ‘Proposal for risk adaptive surveillance system’ is available: HERE
Team-NB is proposing a structured framework for how risk-adaptive surveillance should actually work under the MDR/IVDR reform, filling in details they think the Commission’s proposal (COM(2025) 1023) left open.
Team-NB recommends a new Article 48c, creating three surveillance tiers: initial/enhanced, medium, and reduced. Every manufacturer would start at the highest level after initial certification. Then, they can step down to “medium” after three years if there are no serious incidents with confirmed causal relation to the device, no major nonconformities, no failed CAPAs, etc. during that time. Then brought to “reduced” level after six years, under the same criteria. Re-escalation back up can happen immediately if a triggering event occurs.
A one-page brief on the above is also available: HERE
Team-NB’s 2nd EU Regulations Discussion Day
It is scheduled for 6 November 2026 and more details are available: HERE
United Kingdom
Guidance Re: “On the market” vs “Putting into service”
The MHRA published guidance on how to determine if a product is being placed “on the market” versus being “put into service”: HERE
The reason for the distinction is that devices registered as “on the market” are subject to the MHRA’s annual registration fee, whereas devices being “put into service” are not.
Guidance on IVD Point-of-Care Test Devices Updated
The webpage is available: HERE
It was updated to remove outdated references in several sections; update the section on training and UKAS accreditation for POCT; update the section on incident reporting to clarify the scope and reporting routes for medical device incidents in different parts of the UK.
Custom-Made Medical Devices Guidance Updated
The updated guidance document is available: HERE
It includes minor changes, such as removing the example provided around “Prescribed ophthalmic specialist” manufactured by a glazing shop, and to remove the UK MDR 2002 cited definition of a ‘medical specialist’.
Requirements for Specific Devices Guidance Updated
The updated guidance is available: HERE
It includes changes such as updated links, and other minor clarifications.
Switzerland
Updated Guidance Documents
A large number of guidance documents were updated in July, many of which are to align with swissdamed becoming mandatory as of 1 July 2026.
The documents are available: HERE
New Information Sheet on swissdamed Pricing
It is available: HERE
It clarifies further which devices are subject to the new registration fee, how the fee is calculated, and when billing will occur.
