Business guidance
Rules, requirements and how-tos for running your business — organised by topic, with industry-specific guidance on the sector pages.
Guidance for healthcare & social care
Show all guidanceAI medical device compliance
MHRA requirements for AI as a Medical Device (AIaMD) and Software as a Medical Device (SaMD). Covers classification, registration, technical documentation, quality management, post-market surveillance, and data protection for health AI.
Healthcare & Social CareCare Inspectorate Scotland inspection preparation checklist
Checklist for Care Inspectorate inspection readiness covering documentation, staff training records, care plans, Health and Social Care Standards evidence, premises, environment, and safeguarding arrangements.
Healthcare & Social CareChildcare Funding Entitlements: A Guide for Providers
How government childcare funding works for providers, covering the universal and targeted 15-hour entitlements, the 30-hour working-parent entitlement from 9 months, Tax-Free Childcare, provider agreements with local authorities, and claiming processes.
Healthcare & Social CareChildcare Ofsted Compliance Checklist
Comprehensive compliance checklist for Ofsted-registered childcare providers covering registration, safeguarding, staffing, premises, records, and insurance.
Manufacturing & EngineeringChoosing a UK Approved Body for medical devices
How to select and engage a UK Approved Body for conformity assessment of your medical device. Covers the 9 designated bodies and their scope, when an Approved Body is required, the assessment process by device class, and when self-certification is permitted.
Healthcare & Social CareCIW inspection preparation checklist
Verification checklist for CIW inspection readiness. Covers Statement of Purpose, Responsible Individual duties, staff qualifications and Social Care Wales registration, care documentation, Welsh language provision, premises and environment, and safeguarding arrangements.
Manufacturing & EngineeringClassify your medical device for the GB market
How to classify your medical device under the UK Medical Devices Regulations 2002. Covers Class I through III for general devices, active implantable devices, IVDs (current Annex system and future Class A-D), and Software as a Medical Device.
Healthcare & Social CareClinical governance and quality improvement
Clinical governance framework for healthcare providers covering patient safety culture, clinical audit, incident investigation, duty of candour, complaints handling, and continuous quality improvement. Links governance activities to the CQC Well-led domain and explains why effective governance protects both patients and your organisation.
Healthcare & Social CareComply with the EYFS Statutory Framework
How to implement the Early Years Foundation Stage (EYFS) framework in your childcare setting. Covers safeguarding, staff ratios, qualifications, learning areas, assessment, and Ofsted inspection preparation.
Healthcare & Social CareData protection for healthcare providers
How healthcare providers must handle patient data under UK GDPR, including special category health data requirements, Caldicott Principles, the common law duty of confidentiality, and record retention requirements.
Healthcare & Social CareDevolved care inspectorates: quick comparison reference
Quick-lookup reference comparing the three devolved care inspectorates: Care Inspectorate (Scotland), CIW (Wales), and RQIA (Northern Ireland). Covers registration, fees, grading systems, quality frameworks, enforcement powers, workforce bodies, and disclosure schemes.
Healthcare & Social CareFood Safety for Childcare Providers
Food safety and nutrition requirements for childcare settings, including food business registration, allergen management, HACCP systems, and Ofsted nutrition expectations.
Healthcare & Social CareHealthcare and social care regulation (CQC)
CQC registration requirements for health and social care providers in England, including detailed guidance on regulated activities, costs, and devolved nation alternatives.
Healthcare & Social CareHealthcare premises and equipment requirements
CQC Regulation 15 premises and equipment requirements, radiation protection under IRR 2017, healthcare ventilation, medical gas systems, decontamination of reusable devices, accessibility obligations, and fire safety for healthcare premises.
Healthcare & Social CareHealthcare professional registration requirements
Registration requirements with GMC, NMC, GDC, GPhC, and HCPC for healthcare employers and professionals.
Healthcare & Social CareHealthcare provider annual compliance checklist
Annual checklist of recurring compliance obligations for CQC-registered healthcare providers covering registration, workforce, clinical governance, premises, data protection, and policy reviews.
Healthcare & Social CareHealthcare regulation across the UK nations
Comparison reference for healthcare regulation in England (CQC), Scotland (HIS and Care Inspectorate), Wales (HIW and CIW), and Northern Ireland (RQIA). Covers registration, inspection frameworks, workforce registration, and key differences between the four nations.
Healthcare & Social CareInfection prevention and control for healthcare providers
How to meet infection prevention and control (IPC) requirements under the Health and Social Care Act 2008 Code of Practice (Hygiene Code). Covers standard precautions, environmental cleaning, outbreak management, antimicrobial stewardship, and CQC inspection expectations.
Healthcare & Social CareInsurance for Childcare Businesses
Insurance requirements and options for childcare providers including public liability, employer's liability, professional indemnity, and vehicle insurance for outings.
Manufacturing & EngineeringMedical device compliance checklist
Verification checklist for medical device manufacturers and UK Responsible Persons. Covers device classification, conformity assessment, technical documentation, UKCA/CE marking, MHRA registration, PMS system, vigilance reporting, labelling, and ongoing obligations.
Manufacturing & EngineeringMedical devices and equipment compliance
Regulatory requirements for medical devices including vigilance reporting and equipment maintenance.
Manufacturing & EngineeringMedical devices: placing on the GB market
How to comply with the UK Medical Devices Regulations 2002 when placing medical devices on the Great Britain market. Covers device classification, UKCA marking transition timelines, MHRA registration, essential requirements, clinical evidence, conformity assessment by device class, post-market surveillance, and Unique Device Identification.
Healthcare & Social CareMedicines and controlled drugs compliance
Legal requirements for handling, storing and administering medicines including controlled drugs in healthcare settings.
Healthcare & Social CareMeet RISCA 2016 compliance requirements for care services in Wales
How to meet the ongoing compliance requirements under the Regulation and Inspection of Social Care (Wales) Act 2016 and the Regulated Services (Service Providers and Responsible Individuals) (Wales) Regulations 2017, including Statement of Purpose, governance, staffing, service user engagement, and complaints handling.
Healthcare & Social CareMeet RQIA Minimum Care Standards
How to meet the Minimum Care Standards that RQIA uses to assess your health or social care service in Northern Ireland. Covers identifying your applicable standards, self-assessment, gathering evidence, and addressing common shortfalls.
Healthcare & Social CareMeet Scotland's Health and Social Care Standards
How to meet Scotland's Health and Social Care Standards (My support, my life), covering the five headline standards, self-assessment approaches, evidence of compliance, and common shortfalls identified by the Care Inspectorate.
Retail & Consumer GoodsMHRA authorisation for medicines and medical devices
How to obtain MHRA authorisation for medicines and medical devices in the UK. Covers Marketing Authorisations, wholesale dealer licences, manufacturer licences, and medical device registration including UKCA vs CE marking.
Retail & Consumer GoodsMHRA licensing for medicines and medical devices
MHRA licensing requirements for manufacturing, distributing, and importing medicines and medical devices in the UK.
Technology & DigitalNetwork and Information Systems (NIS) Regulations
The NIS Regulations 2018 (as amended in 2022) require operators of essential services and relevant digital service providers to implement appropriate security measures, report significant incidents within 72 hours, and cooperate with sector-specific competent authorities. The Cyber Security and Resilience Bill (introduced November 2025) will further expand scope to managed service providers, data centres, and critical suppliers.
Healthcare & Social CareNHS Data Security and Protection Toolkit compliance
How to complete the NHS Data Security and Protection Toolkit (DSPT) annual self-assessment if you handle NHS patient data. Covers the two assessment tracks (CAF-aligned and standards-based), evidence gathering, submission process, and achieving Standards Met status.
Healthcare & Social CareOperating care services across UK nations: cross-border registration and compliance
Comprehensive guide for care providers operating in more than one UK nation. Covers separate registration requirements with each devolved inspectorate, workforce portability, disclosure and barring schemes, quality framework differences, and the practical implications of no mutual recognition between CQC, Care Inspectorate Scotland, CIW, and RQIA.
Healthcare & Social CareOutdoor Learning and Forest School in Early Years
Requirements for outdoor learning and forest school provision in early years settings, including risk assessment, insurance, qualifications, and health and safety compliance.
Manufacturing & EngineeringPlacing medical devices on the Northern Ireland market
How to comply with the Northern Ireland medical device regime under the Windsor Framework. Covers EU MDR/IVDR requirements, CE marking, UKNI marking via UK Approved Bodies, EU Authorised Representative, and dual compliance for manufacturers selling in both GB and NI.
Manufacturing & EngineeringPost-market surveillance for medical devices
How to establish and maintain a post-market surveillance system for medical devices on the GB market under the enhanced requirements in force from 16 June 2025. Covers PMS plans, proactive data collection, trend analysis, summary reporting, Field Safety Corrective Actions, and data retention periods.
Healthcare & Social CarePremises and Fire Safety for Childcare Settings
Premises requirements and fire safety for childcare providers including EYFS space standards, fire risk assessment, fire drills, evacuation procedures, and daily safety checks.
Healthcare & Social CarePrepare for an Ofsted Inspection
How to prepare for an Ofsted inspection of your childcare setting. Covers what inspectors look for under Ofsted's renewed inspection framework, self-evaluation, evidence gathering, and how to handle the inspection day.
Healthcare & Social CarePrepare for an RQIA inspection
Inspection readiness checklist for RQIA-registered services in Northern Ireland. Covers documentation, staffing records, care plans, premises environment, complaints handling, safeguarding, and what to expect on inspection day.
Healthcare & Social CareRecord-Keeping and Data Protection for Childcare Providers
Mandatory record-keeping requirements for childcare providers under EYFS, data protection obligations under UK GDPR, and how to handle complaints and significant events.
Healthcare & Social CareRegister a care service with Care Inspectorate Wales (CIW)
Step-by-step guide to registering a regulated care service with Care Inspectorate Wales (CIW) under the Regulation and Inspection of Social Care (Wales) Act 2016. Covers application requirements, Responsible Individual appointment, service manager fitness, premises standards, fees, and expected timescales.
Retail & Consumer GoodsRegister a food business in Wales
How to register a food business with one of the 22 Welsh local authorities. Covers the Welsh-specific registration process, bilingual forms, what happens after registration, and key differences from the England registration system.
Healthcare & Social CareRegister a health or social care service with RQIA
Step-by-step guide to registering a health or social care service with the Regulation and Quality Improvement Authority (RQIA) in Northern Ireland. Covers application requirements, fit person criteria, premises standards, registration conditions, fees, and expected timescales.
Retail & Consumer GoodsRegister and run a food business
How to register your food business with your local authority, meet food hygiene requirements, and achieve a good food hygiene rating. Essential compliance for all food businesses including home-based and mobile.
Healthcare & Social CareRegister as a Childminder in England
Complete guide to becoming a registered childminder, from pre-registration training and DBS checks to Ofsted registration and setting up your self-employed childminding business.
Healthcare & Social CareRegister Holiday Clubs and Out-of-School Care
Ofsted registration requirements for holiday clubs, breakfast clubs, after-school clubs, and wraparound care. Covers when registration is required, exemptions, and compliance obligations.
Healthcare & Social CareRegister with the Care Inspectorate Scotland
Step-by-step guide to registering a care service with the Care Inspectorate Scotland under the Public Services Reform (Scotland) Act 2010, including application requirements, fitness assessments, premises standards, fees, and expected timescales.
Healthcare & Social CareRegister with the Care Quality Commission (CQC)
Complete step-by-step guide to CQC registration for healthcare providers in England, including what activities require registration, annual fees, fit and proper person requirements, and the full registration process.
Healthcare & Social CareRegister your care staff with Social Care Wales
How to ensure your care staff register with Social Care Wales, including mandatory registration categories, qualification requirements, the Code of Professional Practice, fitness to practise processes, and your obligations as an employer.
Manufacturing & EngineeringReport a medical device safety incident to MHRA
Step-by-step guide to reporting serious medical device incidents to MHRA via the MORE portal. Covers incident identification, timeline classification (2, 10, or 15 calendar days), MIR form submission, follow-up investigation, CAPA, and Field Safety Corrective Actions.
Healthcare & Social CareResponding to Care Inspectorate enforcement action in Scotland
What to do when the Care Inspectorate imposes conditions, issues improvement notices, or initiates cancellation of your registration, including your rights of appeal under the Public Services Reform (Scotland) Act 2010 and the sheriff court appeal process.
Healthcare & Social CareRespond to CIW enforcement action in Wales
What to do when Care Inspectorate Wales imposes conditions, issues improvement notices or restriction notices, or initiates cancellation of registration. Covers your rights, appeal routes via the First-tier Tribunal, and how to respond effectively to protect your service.
Healthcare & Social CareRespond to RQIA enforcement action
What to do if RQIA takes enforcement action against your health or social care service in Northern Ireland. Covers failure to comply notices, conditions on registration, urgent procedures, cancellation proceedings, appeal rights, and how to seek legal representation.
Healthcare & Social CareRun a care home or other residential care service
Residential care is one of the most closely regulated activities in the UK. Adult care and nursing homes and domiciliary care register with the CQC in England; children's homes register with Ofsted. On top of registration sit the registered manager, enhanced DBS checks for every member of care staff, mental capacity and deprivation-of-liberty safeguards, adult safeguarding duties and fire safety designed around residents who cannot self-evacuate.
Healthcare & Social CareRunning clinical trials in the UK
How to get MHRA authorisation for clinical trials of investigational medicinal products (CTIMPs). Covers combined review process, GCP requirements, safety reporting, informed consent, and the 2026 regulatory framework.
Healthcare & Social CareSafeguarding and Child Protection for Childcare Providers
Creating and implementing safeguarding policies for childcare settings. Covers the designated safeguarding lead role, recognising abuse, reporting procedures, Prevent duty, and staff training requirements.
Healthcare & Social CareSafeguarding and mental capacity in healthcare
Legal duties for safeguarding vulnerable adults and making decisions for people who lack mental capacity.
Healthcare & Social CareSafer Recruitment for Childcare Settings
Step-by-step safer recruitment for childcare providers including DBS enhanced checks, disqualification declarations, reference checking, interview techniques, and maintaining staff suitability records.
Healthcare & Social CareSet up and run a regulated health practice
Opening a GP surgery, dental practice, clinic, pharmacy or optical practice means clearing two gateways — registering the service with the CQC (in England) and ensuring every clinician holds their professional registration — then running the practice within the rules on medicines and controlled drugs, infection control, premises and health data.
Healthcare & Social CareSocial care business planning and insurance
Business planning essentials for social care providers. Covers insurance requirements, Care Act 2014 obligations in England, financial viability and fee setting, and a checklist of what you need before applying to register.
Healthcare & Social CareSocial care registration and regulators
Guide to registering as a social care provider across all four UK nations. Covers CQC registration in England, Care Inspectorate in Scotland, CIW in Wales, and RQIA in Northern Ireland — including fees, registered manager requirements, and inspection frameworks.
Healthcare & Social CareSocial care workforce qualifications and staffing
Workforce requirements for social care providers across the UK. Covers the Care Certificate and qualifications in England, mandatory SSSC registration in Scotland, and staffing level principles for care homes and domiciliary care.
Technology & DigitalSoftware and AI as medical devices (SaMD/AIaMD)
How MHRA regulates software and AI-powered medical devices. Covers the SaMD definition and boundary guidance, current classification under UK MDR 2002, future reclassification to Class IIa minimum, Good Machine Learning Practice principles, predetermined change control plans, and clinical evidence for AI.
Healthcare & Social CareSSSC workforce registration for care providers in Scotland
How to ensure your care staff register with the Scottish Social Services Council (SSSC), including registration categories, qualification requirements, timescales, fitness to practise, PVG scheme membership, and employer obligations.
Healthcare & Social CareStart a clinical laboratory service
How to set up and operate a clinical laboratory in the UK. Covers UKAS accreditation, CQC registration, HTA licensing, MHRA requirements, professional registration, and quality standards for medical testing services.
Healthcare & Social CareStart and Register a Childcare Business
Complete guide to registering and launching a childcare business in England, from Ofsted registration to EYFS compliance. Covers nurseries, preschools, and childminders.
Manufacturing & EngineeringUKCA and CE marking for medical devices
How to choose between UKCA and CE marking for your medical device on the GB market. Covers UKCA marking via UK Approved Bodies, CE marking transitional acceptance (2028/2030 deadlines), the MHRA consultation on indefinite CE recognition, dual marking for GB and NI access, and NI-specific requirements.
Healthcare & Social CareUnderstanding care regulation in Wales: CIW and RISCA 2016
How Care Inspectorate Wales (CIW) regulates care services under RISCA 2016, the Responsible Individual model, Welsh Language Standards obligations, and how the Welsh framework differs from CQC in England and Care Inspectorate in Scotland.
Healthcare & Social CareUnderstanding RQIA: healthcare and social care regulation in Northern Ireland
How healthcare and social care regulation works in Northern Ireland under the Regulation and Quality Improvement Authority (RQIA). Explains the integrated HSC system, how RQIA differs from CQC, Minimum Care Standards, inspection methodology, and RQIA's current statutory role.
Healthcare & Social CareUnderstanding the Care Inspectorate Scotland
Comprehensive explainer of how the Care Inspectorate Scotland operates, its regulatory model under the Public Services Reform (Scotland) Act 2010, how it differs from CQC in England, the Health and Social Care Standards, and its relationship with the SSSC and Healthcare Improvement Scotland.
Healthcare & Social CareWhich education and childcare rules apply to your business
Education and childcare businesses are regulated by what they do and who they serve. Early years and out-of-school childcare register with Ofsted in England. Independent schools register with the Department for Education. Higher education providers register with the Office for Students. Driving instructors join the DVSA's ADI register (Great Britain-wide — Northern Ireland has the DVA's separate register). Domiciliary care and social work have their own regulators. Find your provider type below, then follow the route that matches.
Retail & Consumer GoodsWhich health and care rules apply to your business
Health and care businesses are regulated twice over: the service registers with a care regulator (CQC in England, with separate regulators in Scotland, Wales and Northern Ireland — and Ofsted for children's social care), and the professionals who deliver it register with their own statutory regulator (GMC, NMC, GDC, GPhC, GOC or HCPC). Find your provider type below, then follow the route that matches.
General rules
Common requirements shown separately from guidance directly classified to this sector.
Check if you need to register for VAT
Find out if your business must register for VAT based on your taxable turnover. Covers the £90,000 threshold, what counts as taxable turnover, the rolling 12-month test, and when voluntary registration makes sense.
Business StructureMandatory registrations every business must complete
Step-by-step guide to the registrations every business must complete before trading, regardless of sector. Covers HMRC tax registration, ICO data protection fee, mandatory insurance, and pension auto-enrolment.
Premises & OperationsMeet your business waste duty of care
Understand your legal responsibilities when producing, storing, or disposing of business waste. Covers using registered waste carriers, completing waste transfer notes, and the stricter rules for hazardous waste.
Compliance & LegalPre-trading compliance checklist
A concise yes/no checklist to verify you have completed all mandatory pre-trading requirements, including business registration, tax, insurance, licences, premises approvals, and data protection.
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