Below is an overview of the September 2026 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., revision to IVD classification guidance document MDCG 2020-16.

Europe

Minor Updates to Vigilance Contacts List

The updated PDF is available: HERE

The section for the Slovakian Competent Authority was updated to remove one of the email addresses indicated as a vigilance contact.

Casus’ vigilance resource was updated accordingly: Europe Vigilance Requirements Tool

MDR/IVDR Reform Proposal Continues Review Under New Presidency

The reform proposal continues to make its way through review, with the latest meeting being 24 September 2026: HERE

New Opportunity to Apply for Joint Scientific Consultations

On 23 September, the Commission opened the 4^th request period for joint scientific consultations (JSCs) for 2026: HERE

The submission period is open until 21 October 2026 to developers of both medicinal products and medical devices (for medical devices classified as class IIb or III and, in vitro diagnostic medical devices classified as class D).

Expert Panel Reviews

Decision and opinion CECP-EMA/EX/0000335537 (Orthopaedics, traumatology, rehabilitation, rheumatology) available: HERE

The above was in relation to a Class III resorbable device injected into the knee for mild to moderate osteoarthritis.

Decision and opinion CECP-EMA/EX/0000171363 (Orthopaedics, traumatology, rehabilitation, rheumatology) available: HERE

The above was in relation to a Class III implantable bioabsorbable orthopaedic screw.

MedTech Europe Statement on EU Procurement Regulation

MedTech Europe’s first reaction statement is available: HERE

MedTech Europe welcomed the Commission’s proposed Public Procurement Regulation, published 9 September 2026, mainly because it moves public buyers away from awarding contracts on lowest price alone and toward best price-quality ratio. However, the association states that the proposal does not go far enough, since many of its strongest provisions are optional or deferred. It further asks that the European preference rules and the new supply security duties be reconsidered for healthcare, arguing that origin requirements could delay patient access and that information demands should be coordinated across Europe instead of set buyer by buyer.

United Kingdom

Medical Device Reform Bill Introduced

The reform bill is available: HERE

The UK Government has formally proposed amendments to the Health Bill, which would allow the MHRA to create its own approval system for medical devices in the future.

The idea being explored is that devices placed on the Great Britain market through the domestic route (i.e., not through CE marking or international reliance), may one day need a license issued directly by the MHRA instead of relying on UKCA certificates issued by UK Approved Bodies. Meaning, the MHRA may possibly move toward a regulator-led system, similar to the Australian TGA model (although the MHRA has not indicated which model it has in mind in the above link). UK Approved Bodies may still have a role, but what that would look like is uncertain.

For now, the UKCA system stays in place and the UK’s approach to relying on CE Marking and/or its proposed International Reliance framework remains unchanged. The details, including which devices would be covered, fees, and timing, have not been decided and would need to be worked out later through consultation and further legislation.

TEAM-AB Guidance: Role of Approved Bodies in Vigilance

Team Approved Body’s new guidance is available: HERE

It provides feedback on the UK Approved Body’s role for UKCA Marked devices, such as:

Switzerland

Swissmedic Guidance and Other Document Updates

All of the below documents are available: HERE

Swiss Medtech swissdamed Webinar (German and French)

Swiss Medtech is hosting a webinar on swissdamed registration: HERE

The German webinar will be on 2 October 2026, and the French webinar will be on 2 November 2026. There is no fee for Swiss Medtech, BVMed, and AUSTROMED members, and fee of CHF 60 for all others.

As a reminder, Swissmedic is hosting its own free webinar in English on 10 November 2026. More information on the date and how to sign up is available: HERE

IMDRF/MDSAP

IMDRF September 2026 Meeting in Singapore

The meeting PowerPoint Presentations are available: HERE

Presentation materials are available from the workshops conducted, working groups, management committee, official observers, and affiliate members.

MDSAP Guidance on Validating Certificates

Information and links on how to confirm the validity of MDSAP certificates is available: HERE