MHRA vs Swissmedic: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of MHRA (United Kingdom) vs Swissmedic (Switzerland).
MHRA
Medicines and Healthcare products Regulatory Agency
United Kingdom
Post-Brexit, the MHRA operates an independent regulatory framework for medical devices in the UK. The UK Conformity Assessed (UKCA) marking is replacing CE marking for the UK market. The MHRA is devel…
Class I, IIa, IIb, III
UKCA marking via UK Approved Body
- ▸UKCA marking
- ▸UK device registration
- ▸Yellow Card adverse event reporting
- ▸UK Approved Body oversight
Swissmedic
Swiss Agency for Therapeutic Products
Switzerland
Swissmedic regulates medical devices in Switzerland under the revised Medical Devices Ordinance (MedDO), which is largely aligned with EU MDR. Switzerland recognizes EU CE certificates for most device…
Class I, IIa, IIb, III
EU CE recognition / Swiss conformity assessment
- ▸MedDO compliance oversight
- ▸Recognition of EU CE certificates
- ▸Swiss market surveillance
- ▸MDSAP participation
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