New swissdamed Registration Fees Starting January 2027
29 May 2026Below is an overview of the May 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., UK’s draft regulation introducing its International Reliance program, and new Swiss registration fees starting in 2027.
Europe Updates
MDR/IVDR Reform Updates
The MDR/IVDR reform proposal is still under active review across the relevant EU bodies:
- The European Economic and Social Committee published its opinion on the simplification proposal: HERE
- The French Senate published their opinion: HERE
- The Working Party on Pharmaceuticals and Medical Devices noted they met on Clusters 4 and 5 of the proposal: HERE and HERE
- Status of various member state reviews can be found: HERE
Some of the opinions support the majority of the simplification efforts, while some raise objections around items such as Article 17’s amendment on reprocessing of devices.
On a related note, an updated Notified Body (NB) survey on certifications and applications was published: HERE
The recent survey notes:
- MDR transition remains stalled: 42% of NBs say fewer than 25% of their Directive-era clients have completed full MDR transfer, and no NB reported 100% completion.
- Manufacturers are delaying documentation: 92% of NBs report manufacturers requesting technical documentation submission delays, creating potential scheduling issues on NB capacity once the MDR/IVDR deadlines near.
New Version of EUDAMED Deployed
The release notes for EUDAMED version 2.27.0 are available: HERE
Among other changes, the system now includes:
- The initiation of the Mergers and Acquisitions (M&A) flow directly in the ‘My Actor data’ section.
- The Clinical Evaluation Consultation Procedure (CECP) feature
- Auto-update of the EMDN code changes
Minor Updates to MIR Form
The changelog, noting a bug fix, can be found: HERE
Health Technology Assessments (HTA)
New guidance available:
Further, on June 19, 2026, the Commission will host a webinar for health technology developers of high-risk medical devices. It will explain the process for joint clinical assessments (JCA) and joint scientific consultations (JSC) for high-risk medical devices and IVDs. Interested parties can sign up: HERE
As well, the Commission has opened an initiative to assess the EU rules on HTA: HERE
Digital Omnibus and AI Act
The AI Act High-risk use date has been postponed: HERE
This decision was made as part of the Omnibus proposal, which was intended to streamline overlapping digital regulations in Europe, including the AI Act, GDPR, and more.
For AI medical devices, the agreement keeps them in scope of the AI Act’s high-risk framework, so overlapping requirements remain. However, the postponement is offered as a compromise, giving stand-alone high-risk AI systems until 2 December 2027 to comply, and high-risk AI systems embedded in products until 2 August 2028 to comply.
It also allows more of the AI Act compliance work to be folded into the MDR/IVDR conformity assessment and QMS, rather than in a separate AI-only process. Note, however, that the exact mechanism for integrating AI Act requirements into MDR/IVDR conformity assessment has been delegated to the Commission to define by August 2027, i.e., more specifics still to come.
MedTech Europe published a response to the overall Digital Omnibus package: HERE
They note that the Council is walking back the Commission’s original proposals, weakening certain simplification goals while simultaneously introducing additional burdens, e.g., rolling back GDPR simplification and rejecting a proposed EU-level Single Entry Point for cyber incident reporting in favor of individual national reporting. Essentially, that it impacts Europe’s ability to compete, innovate, and attract investment.
Proposal to Update Agreement with Monaco
The proposed update to the EU Agreement with Monaco is available: HERE
It amends the 2003 Agreement (covering medicines, cosmetics, and medical devices), to update the regulatory frameworks included. For example, to update the old Directives to the EU MDR/IVDR, and AI Act.
Team Notified Body
Team-NB published several updates:
- Update on the Digital Omnibus and AI Act, noting it has no impact on the format of the conformity assessment of AI medical devices: HERE
- Further: “We must highlight that the extension of transition periods by only one year to 02 August 2028 does not the [sic] match the fact that almost two years have already passed largely unused by legislators to enable national designation procedures of AI notified bodies.”
- Link to the Notified Body annual sector survey: HERE
- Team-NB notes that all NBs currently have availability for assessments. However, this may change as outstanding applications are received closer to the end of the transition period.
- Legal expert opinion on the proposed revision of Article 50, on fee reductions, payment deferrals and possibility for forced acceptance of conformity assessment requests: HERE
- Survey on the Team-NB technical documentation trainings given to manufacturers: HERE
UK Updates
Conformity Assessment Flowchart Updated
The updated version is available: HERE
The flowchart for UK MDR 2002 Systems and Procedure Packs Conformity Assessment Routes was updated:
- From: Follow the procedure for Annex IV for type examination by an Approved Body
- To: Follow the procedure for V. Limited to aspects relating to obtaining sterility only
Ask for a Regulatory Advice Meeting Webpage Updated
The updated page is: HERE
Among other changes, the MHRA has added the following into the scope of work it cannot provide: “A determination on whether your organisation qualifies as a health institution (though we can provide general advice on the health institution exemption and how it apples [sic] to your products)”
Clinical Investigations for Medical Devices Webpage Updated
The webpage can be found: HERE
Updates were made to the following sections:
- Fee waiver programme details: notes added
- Applications for an investigative medicinal product and medical device – IMP+Device: updates to include the latest guidance
Switzerland Updates
Updated Guidance & Forms
The following were updated:
- PSR form and trend report form
- Economic Operator Obligations Info Sheet
- swissdamed Actor User Guide
- Manufacturer Incident Report (MIR) Guidance
All documents are available: HERE
swissdamed Webinar Recording Published
On 28 May 2026, Swissmedic conducted a webinar on swissdamed. The recording and PowerPoints are available: HERE
Topics included:
- Demo of database
- New fee structure starting January 2027
- Overview of Actor and device registration process
- Upcoming functionality for importers to link themselves to manufacturers
- How Swiss Authorized Representative transfers are processed in swissdamed
IMDRF Updates
The IMDRF has opened a consultation on its ‘Guidance on the Control of Products and Services Obtained from Suppliers’: HERE
Interested parties have until 6 July 2026 to provide feedback.
