July “In All Other News”: MDCG 2026-5, MDR/IVDR Reform Progress, and more
7 August 2026
New Swissmedic Webinar on swissdamed Scheduled for November 2026
3 September 2026August was a slow month for regulatory updates, with minimal news coming out of Europe, the UK, and Switzerland. Below we outline the updates that did occur.
Europe
EUDAMED 2.75.5 Deployed
EUDAMED has been updated, with version now 2.27.5 deployed: HERE
Among other changes, the most recent release includes:
- Mergers and Acquisitions (M&A) functionality now supports the initiation of the M&A flow directly in the “My Actor data” section of EUDAMED, including a centralized management screen to view, track, and withdraw requests, as needed.
- The Clinical Evaluation Consultation Procedure (CECP) feature, as well as Mechanism for Scrutiny (MfS) feature are now available in the EUDAMED.
- When searching for the Certificates in the public site, the system displays the expiry date in red and an exclamation mark next to it, allowing easier differentiation between expired and not expired Certificates.
EMDN 3rd Training Recording Published
It is available: HERE
Packaging and Packaging Waste Regulation (PPWR) FAQs Updated
The updated FAQs are available: HERE
It includes new FAQs, such as:
- Who is the manufacturer of transport packaging?
- Who is the manufacturer of branded packaging?
- Is packaging used to ship product parts between manufacturing sites, for finalization or assembly, considered placed on the market and therefore subject to PPWR rules?
- What should happen to packaging held in stock or already produced prior to 12 August 2026, but not yet placed on the market by that date? Will operators be obliged to destroy, remanufacturer or re-label it?
- Can manufacturers delegate responsibilities to third parties?
- Article 18 lays down obligations on importers. What should an importer be aware of?
Finland Competent Authority on AI Transparency
Finnish Competent Authority FIMEA published a page on the AI Regulation’s transparency obligation: HERE
It confirms that the transparency obligations of Article 50 of the EU Artificial Intelligence Regulation (2024/1689) have applied since 2 August 2026, and the purpose of Article 50 is to help people identify interactions with an artificial intelligence system and content produced or manipulated by artificial intelligence.
It further confirms that 1) the transparency obligation also applies to the medical device sector, and 2) transparency obligations do not depend on whether the AI-system is classified as high-risk or not.
Updated Guidance for Joint Clinical Assessments
The notice is available: HERE
Among other things, the updated Commission guidance explains the corresponding steps for health technology developers to provide early information to the Health Technology Assessment (HTA) Secretariat and to access the HTA IT Platform.
Team NB Updates
Position Paper on MDR Reform
The paper is available: HERE
Team-NB advises they support the Commission’s initiative to plan and conduct risk based and proportionate surveillance activities. However, they propose an alternate approach, with the intensity, frequency and modality of surveillance audits, unannounced audits, technical documentation sampling, and batch testing adjusted based on documented criteria such as incident history, PMS/Vigilance data, QMS maturity, and effectiveness of corrective actions. The paper provides more detail into Team-NB’s thought process for the proposed approach.
New MDR Clinical Training for Manufacturers in Dec 2026
Details, including cost, agenda, and sign-up link, are available: HERE
United Kingdom
New Consultation on Fee Changes
The MHRA has opened a new consultation regarding fee adjustments: HERE
The purpose is to obtain feedback on the following proposals:
- Increase most fees by indexation only.
- Targeted increases for a small number of higher-value services.
- Enhanced service standards, guaranteed timelines and rebates for selected services.
- Enhanced support for eligible small and medium-sized enterprises.
- Improvements to the MHRA’s scientific advice service.
- A phased update to the medical devices post-market surveillance fee.
- Adjustments to some existing fees.
The consultation is open until 25 September 2026.
Switzerland
CFS Guidance Updated
The updated guidance is available: HERE
It was updated to include information on swissdamed registration.
IMDRF & MDSAP
New IMDRF Guidance on Essential Principles and Content of PCCPs
The new guidance document is available: HERE
The guidance includes topics such as:
- Manufacturers should plan their Pre-Determined Change Control Plans (PCCPs) carefully up front, as amending it later largely erases the efficiency gains the PCCP was intended to provide.
- Not every jurisdiction accepts PCCPs, and those that do may define differently which software changes require a new submission in the first place. That means the same PCCP may not be useable “as is” across markets, and manufacturers relying on recognition or reliance frameworks need to account for those gaps themselves.
- The document acknowledges that bundling a PCCP into the initial marketing submission increases time-to-market and may delay ROI. Therefore, manufacturers can instead submit the PCCP alongside the first modification submission for the device instead. This allows them to obtain the initial authorization faster and then develop the PCCP with the benefit of early market experience.
IMDRF Implementation Guide Updated
The updated version is available: HERE
This document outlines which IMDRF countries have fully, partially, or have not, implemented various IMDRF principles into their framework.
For example, Brazil, Canada, the EU, Switzerland, and the US (among other countries) have fully implemented IMDRF/SaMD WGN/N10 FINAL: 2013 (Key Definitions on SaMD), while Australia and the UK have partially implemented it.
MDSAP Audit Approach Revised
The latest revision is available: HERE
It includes updates to sections such as on Unique Device Identification (UDI).
