Medical Device News July 2026 Regulatory Update
Stay up to date with the latest EU MDR, IVDR, UK MDR and Swiss Medical Device regulations.
In this episode we cover:
- ✅ Well-Established Technologies (WET)
- ✅ COMBINE Phase 2 expansion
- ✅ New MDCG guidance
- ✅ Harmonized Standards update
- ✅ UK Borderline Guide changes
- ✅ Swissdamed M2M registration
- ✅ Team-NB initiative for Micro & Small Enterprises
- and much more…
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🇪🇺 Europe
Well-Established Technologies (WET) – Delegated Acts Published
European Commission announcement:
https://ec.europa.eu/newsroom/sante/newsletter-archives/77013
Delegated Acts:
- Class III & Implantable Devices
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601451 - Class IIb Implantable Devices
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601359
These delegated acts are part of the Administrative Simplification Agenda.
COMBINE Phase 2 – Expanded Scope
https://ec.europa.eu/newsroom/sante/newsletter-archives/76937
Highlights:
- Clinical trials combining medicinal products with medical devices
- IVD performance studies
- Companion diagnostics
- ATMP combined studies
- Single or separate sponsors
- Future substantial modification procedure
- Joint documentation & protocols
Austria – Common Free Sale Certificate (FSC) Deficiencies
https://www.basg.gv.at/en/companies/medical-devices/certificate-of-free-sale/common-deficiencies
Learn the most common mistakes identified during FSC applications.
SSCP Uploads – MDCG 2026-4
https://health.ec.europa.eu/document/download/a80332cf-e9f0-4d45-8863-3d96e8c2a675_en?filename=mdcg…
Timeline:
- Start: October 2026
- Deadline: February 2027
Harmonized Standards Updated
https://eur-lex.europa.eu/eli/dec_impl/2026/1231/oj
The European Commission has published the latest list of harmonized standards supporting MDR & IVDR compliance.
EU Representative Symbol (EC REP vs EU REP)
MDCG 2021-5 Rev.1
https://health.ec.europa.eu/document/download/e10f7694-67b4-4093-a969-6f7e43747c44_en?filename=md_m…
During the transition period it is acceptable to use:
- EC REP
- EU REP
- or both symbols on different packaging levels.
Team-NB Position Paper
Micro & Small Enterprise Initiative
https://www.team-nb.org/wp-content/uploads/2026/06/Team-NB-PositionPaper-Micro-Small-Entreprise-Ini…
🇬🇧 United Kingdom
MHRA Borderline Guide Updated
Borderline products: medical devices and other products – GOV.UK
The previous statement:
Alcohol-only pre-injection swabs and wipes are considered to be medical devices as are those containing antimicrobial substances…
has been revised to:
Alcohol-only pre-injection swabs and wipes are considered to be medical devices.
This removes antimicrobial-containing wipes from this specific guidance.
🇨🇭 Switzerland
Swissdamed Device Registration
New M2M Upload & Master UDI-DI Support
https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-i…
Official Swissdamed UDI User Guide
Swissdamed Webinar
Swissmedic swissdamed Webinar 28.05.2026
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