What this covers (20 activity descriptions)
  • Ear
  • Eye specialist (private practice)
  • Family planning centre providing medical treatment without accommodation
  • Genito-urinary specialist (private practice)
  • Gynaecologist (private practice)
  • Homeopath (registered medical practitioner)
  • Infectious disease specialist (private practice)
  • Mental health specialist (private practice)
  • Morbid anatomy specialist (private practice)
  • Osteopath (registered medical practitioner)
  • Physiologist
  • Private consultants clinics
  • Psychiatrist (private practice)
  • Radiotherapy treatment centre
  • Social medicine specialist (private practice)
  • Specialist medical consultant (private practice)
  • Specialist medical consultation and treatment
  • Specialist physician and surgeon (private practice)
  • Surgeon (private practice)
  • Urologist (private practice)

What you must comply with

Unique to specialist medical practice activities

registration

GMC Specialist Register entry

GMC
Medical Act 1983
Uk

Consultants must hold entry on GMC Specialist Register via Certificate of Completion of Training (CCT) or Certificate of Eligibility for Specialist Registration (CESR). Required for NHS consultant appointments.

licensing

Controlled drugs licence (specialist practice)

Misuse of Drugs Act 1971
Uk

Specialist practices (e.g. pain clinics, anaesthesia, psychiatry) frequently handle Schedule 2 controlled drugs. Enhanced record-keeping and storage requirements apply. Private prescribers must hold personal Home Office licence.

licensing

Clinical trial authorisation (where applicable)

Medicines for Human Use (Clinical Trials) Regulations 2004
Uk

Required for specialist centres conducting clinical trials of investigational medicinal products. Combined review via IRAS (MHRA + Research Ethics Committee). Major reform effective 28 April 2026 under SI 2025/538.

Applies to all medical and dental practice activities

registration

CQC registration for regulated activities

CQC
Ongoing

Mandatory for all providers of regulated activities in England. Equivalent regulators: HIW (Wales), HIS (Scotland), RQIA (Northern Ireland).

certification

DBS checks for healthcare staff

DBS
Ongoing

Enhanced DBS with barred list check required for all staff in regulated activity with children or vulnerable adults. Recheck recommended every 3 years. Access NI equivalent in Northern Ireland; Disclosure Scotland (PVG scheme) in Scotland.

insurance

Professional indemnity insurance

CQC
Annual

All registered providers must have appropriate indemnity arrangements. Individual practitioners may hold cover via professional body membership or separate policy.

registration

Clinical waste disposal duty of care

Ongoing

Clinical waste is controlled waste. Must use licensed waste carriers and maintain consignment notes for hazardous waste. Separate regimes: SEPA (Scotland), NRW (Wales), DAERA (Northern Ireland).

registration

Health data protection (special category data)

ICO
Annual

Health data is special category data under UK GDPR Article 9. Requires explicit consent or other lawful basis. Data Protection Impact Assessment required for high-risk processing.

inspection

Safeguarding duties (children and adults)

CQC
Ongoing

Duty to safeguard and promote welfare of children (s11 Children Act 2004). Duty to report safeguarding concerns for adults at risk (Care Act 2014). Must have designated safeguarding lead and policies.

inspection

Infection prevention and control

CQC
Ongoing

CQC Regulation 12 requires safe care including IPC measures. Must have IPC policy, designated IPC lead, hand hygiene protocols, and environmental cleanliness standards.

insurance

Employers' liability insurance

HSE
Annual

Required for all employers. Sole practitioners with no employees exempt.

Guidance for this activity

Running 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 upcoming 2026 regulatory changes.

Sector-Specific
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Healthcare 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.

Sector-Specific
Read guide

Healthcare 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.

Sector-Specific
Read guide

Clinical 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.

Sector-Specific
Read guide

Register with the Care Quality Commission (CQC)

Complete step-by-step guide to CQC registration for healthcare providers in England, including what activities require registration, application fees, fit and proper person requirements, and the full registration process timeline.

Sector-Specific
Read guide

Medical 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.

Sector-Specific
Read guide

Infection 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.

Sector-Specific
Read guide

NHS 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 Version 7 requirements, evidence gathering, submission process, and achieving Standards Met status.

Sector-Specific
Read guide

Start 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.

Sector-Specific
Read guide

Social 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.

Sector-Specific
Read guide

Data 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.

Sector-Specific
Read guide

AI 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.

Sector-Specific
Read guide

Medical 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.

Sector-Specific
Read guide

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