MHRA Medical Device Registration
Registered with the UK Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with applicable medical device requirements.
CERTIFICATIONS & TESTING
Compliance Details
Explore the certifications, testing standards and compliance requirements behind Strutt products.
Coverage may vary by market and model. Choose the relevant section below to view supporting information and test documentation.
SECTION 01
Global Standards Compliance
Regulatory registrations and internationally recognized standards supporting Strutt products across key markets.
CE-MDR
Compliant with applicable requirements under the EU Medical Device Regulation, supporting market access and regulatory compliance across the European Union.
HSA Class A Medical Device Registration
Registered with Singapore’s Health Sciences Authority (HSA) as a Class A medical device in accordance with applicable local requirements.
MDEL Medical Device Establishment Licence
Licensed under Canada’s Medical Device Establishment Licence (MDEL) framework, supporting compliance with applicable medical device distribution requirements.
TGA Medical Device Registration
Registered with Australia’s Therapeutic Goods Administration (TGA) in accordance with applicable medical device requirements.
SECTION 02
Safety & Performance
Safety, stability, braking and essential driving performance are evaluated against recognized mobility-device standards.
EN 12184
European standard covering safety requirements and test methods for electrically powered mobility products.
EN ISO 12100:2010
Evaluated against applicable mechanical safety requirements under Machinery Directive 2006/42/EC Annex I.
ISO 7176
International wheelchair standards covering key aspects of safety, stability, braking and functional performance.
SECTION 03
Electrical Safety
Battery and electrical systems are evaluated to help reduce risks associated with electrical faults, overheating and other system-level hazards.
IEC 63281-2-1:2024
Evaluated against safety requirements for personal e-Transporters to support safe and reliable everyday use.
SECTION 04
Wireless Compliance
Wireless systems are evaluated against applicable regional requirements for radio frequency, electromagnetic compatibility and connected functionality.
CE RED
Evaluated under the EU Radio Equipment Directive for radio performance, electromagnetic compatibility and applicable wireless requirements.
RCM / RSM
Supports compliance with applicable Australian requirements for radio communications, electromagnetic compatibility and electrical safety.
SECTION 05
Cybersecurity
Connected functions are evaluated against applicable cybersecurity requirements to support secure communication and responsible data handling.
CE RED 3.3 Cybersecurity
Cybersecurity testing covering network protection, personal data and privacy requirements for connected radio equipment.
SECTION 06
Water Resistance
Environmental testing helps verify that the product can withstand water exposure encountered during normal everyday use.
IPX5 Water Resistance
Designed to handle everyday splashes and light rain, with IPX5-rated water resistance for added confidence in daily use.
SECTION 07
Materials & Environmental Compliance
Materials and components are evaluated against applicable chemical, substance and environmental compliance requirements across key markets.
RoHS
Evaluated for compliance with applicable restrictions on hazardous substances in electrical and electronic equipment.
REACH SVHC
Evaluated against applicable REACH requirements for Substances of Very High Concern (SVHC).
WEEE Registration
Registered under applicable Waste Electrical and Electronic Equipment (WEEE) requirements, supporting responsible end-of-life collection and recycling.
Certifications, test results, and compliance requirements vary by market, model, and configuration. Please refer to the applicable local product version for details.
