Medical Devices Regulations 2002: Primary UK legislation governing medical devices, setting out essential requirements for safety and performance
UK Medical Devices Regulations 2023: Updated regulatory framework for medical devices in the UK post-Brexit
Consumer Rights Act 2015: Legislation protecting consumer rights in B2C transactions, including quality standards and fitness for purpose
Sale of Goods Act 1979: Fundamental legislation governing the sale of goods, including implied terms about quality and fitness
Supply of Goods and Services Act 1982: Legislation governing contracts for the supply of goods and services, including implied terms
Health and Safety at Work Act 1974: Primary legislation for workplace health and safety, relevant for medical equipment use in professional settings
EU MDR 2017/745: Retained EU law governing medical devices, including classification, conformity assessment, and safety requirements
EU IVDR 2017/746: Retained EU law specifically governing in vitro diagnostic medical devices
MHRA Guidelines: Regulatory guidance from the Medicines and Healthcare products Regulatory Agency for medical device compliance
UK GDPR: Data protection legislation relevant if medical equipment processes personal data
Data Protection Act 2018: UK's implementation of data protection requirements, including special provisions for health data
ISO 13485: International standard for medical devices quality management systems
Unfair Contract Terms Act 1977: Legislation controlling unfair terms in contracts, particularly regarding limitation of liability
Consumer Protection Act 1987: Legislation establishing strict liability regime for defective products
WEEE Regulations: Waste Electrical and Electronic Equipment regulations governing disposal and recycling of electronic equipment
RoHS Regulations: Restriction of Hazardous Substances regulations limiting use of harmful materials in electronic equipment
Product Safety and Metrology Regulations: Regulations ensuring product safety and correct measurement standards for medical equipment
