Manufacturing & Engineering

Set up and run a safe repair and installation business

Repairing, maintaining and installing machinery and equipment — in your own workshop and on customers' sites — carries machinery, electrical, lifting, working-at-height and hazardous-substance risks. Whatever you work on, this is the universal spine. It takes you through your core workplace health and safety duties, control of hazardous substances, work equipment safety, manual handling, fire safety, employers' liability insurance, equality and data protection.

Relevant to a specific activity in this sector.

Set up and run a safe furniture factory

Furniture-making is machinery- and dust-intensive: sawing, machining, sanding, assembly, upholstery and finishing, working with wood, foams, fabrics, adhesives and lacquers. Whatever you make, this is the universal spine. It takes you through your core workplace health and safety duties, control of wood dust and finishing chemicals, work equipment safety, manual handling, fire safety, employers' liability insurance, equality and data protection.

Relevant to a specific activity in this sector.

Set up and run a safe machinery factory

Making machinery and equipment is metalworking- and assembly-intensive: machining, welding, fabrication, heat treatment and testing. Whatever you make, this is the universal spine. It takes you through your core workplace health and safety duties, control of hazardous substances, work equipment safety, manual handling, fire safety, employers' liability insurance, equality and data protection.

Relevant to a specific activity in this sector.

Set up and run a safe mineral products factory

Making glass, ceramics, cement, lime, concrete and stone products is machinery- and dust-intensive, and respirable crystalline silica is the defining health hazard. Whatever you make, this is the universal spine. It takes you through your core workplace health and safety duties, control of silica and other hazardous substances, work equipment safety, manual handling, fire safety, employers' liability insurance, equality and data protection.

Relevant to a specific activity in this sector.

Set up and run a safe other-manufacturing workshop

Bench and workshop trades cover a wide range of goods — jewellery, musical instruments, sports goods, games and toys, medical and dental instruments, brushes and other goods. Whatever you make, this is the universal spine. It takes you through your core workplace health and safety duties, control of hazardous substances, work equipment safety, manual handling, fire safety, employers' liability insurance, equality and data protection.

Relevant to a specific activity in this sector.

Set up and run a safe paper mill

Making pulp, paper and paper products — from stock preparation and the paper machine through to converting, corrugating and finishing — is heavy-machinery, steam and chemical work. Whatever you make, this is the universal spine. It takes you through your core workplace health and safety duties, control of process chemicals, work equipment safety, manual handling, fire safety, employers' liability insurance, equality and data protection.

Relevant to a specific activity in this sector.

Set up and run a safe printing business

Printing is machinery- and chemical-intensive: presses, cutters and finishing lines, and inks, solvents and cleaning agents. Whatever you print, this is the universal spine. It takes you through your core workplace health and safety duties, control of hazardous substances, work equipment safety, manual handling, fire safety, employers' liability insurance, equality and data protection.

Relevant to a specific activity in this sector.

Machinery and equipment manufacturer: compliance checklist

Use this checklist to confirm your machinery and equipment manufacturing business meets its obligations before you sell. Work through the universal workplace items every manufacturer shares, then the product-conformity and type-approval items for what you make. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Non-metallic mineral products manufacturer: compliance checklist

Use this checklist to confirm your glass, ceramics, cement or concrete products business meets its obligations before a production run. Work through the universal workplace items every manufacturer shares, then the sections for placing products on the market and for environmental permits and emissions trading. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Rubber and plastics manufacturer: compliance checklist

Use this checklist to confirm your rubber and plastics manufacturing business meets its obligations before a production run. Work through the universal workplace and chemicals items every manufacturer shares, then the sections for placing products on the market and for producing plastic packaging. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Repair and installation: compliance checklist

Use this checklist to confirm your repair and installation business meets its obligations. Work through the universal workshop and employment items every business shares, then only the specialist-approval items for the systems you actually work on. If you answer no to any item that applies to you, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Coke and petroleum manufacturer: compliance checklist

Use this checklist to confirm your coke or petroleum business meets its obligations. Work through the universal workplace and major-hazard items, then the environmental and emissions items, then the product and duty items. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Furniture manufacturer: compliance checklist

Use this checklist to confirm your furniture manufacturing business meets its obligations before you sell. Work through the universal workplace items every manufacturer shares, then the furniture fire-safety and product-safety items. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Operate a safe chemical manufacturing site: major-hazard, environmental and explosives controls

A task guide for chemical manufacturers on the site-based controls that apply to a working chemical plant. It covers major-accident hazard duties under COMAH, the environmental permit for the installation, dangerous-substance and explosive-atmosphere controls under DSEAR, and the licensing and supply controls for explosives and their precursors.

Relevant to a specific activity in this sector.

Other manufacturing: compliance checklist

Use this checklist to confirm your workshop or bench-trade manufacturing business meets its obligations before a production run. Work through the universal workshop items every maker shares, then the product-conformity section for what you make. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Paper manufacturer: compliance checklist

Use this checklist to confirm your paper business meets its obligations. Work through the universal workplace items every mill shares, then the sections for environmental permits and water, and for placing products on the market. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Printing business: compliance checklist

Use this checklist to confirm your printing or media reproduction business meets its obligations. Work through the universal workplace and employment items every print works shares, then the solvents, inks and emissions items if you use solvent-based chemicals. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Wood-products manufacturer: compliance checklist

Use this checklist to confirm your wood-products business meets its obligations before a production run. Work through the universal workplace items every manufacturer shares, then the sections for placing products on the market and for wood packaging. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Fabricated metal manufacturer: compliance checklist

Use this checklist to confirm your fabricated metal manufacturing business meets its obligations before a production run. Work through the universal items every fabricator shares, then the sections for placing products on the market and for firearms, ammunition and explosives. If you answer no to any item, follow the linked guide before you proceed.

Relevant to a specific activity in this sector.

Manufacture weapons and ammunition: licensing and major-accident control

Making firearms, ammunition, propellants or explosives is a controlled activity that you cannot start without the right authorities in place. This guide takes you through registering as a firearms dealer and the section 5 authority for prohibited weapons, the explosives manufacture and storage licence, and the major-accident controls (COMAH) that apply once you hold qualifying quantities.

Relevant to a specific activity in this sector.

Manage solvents, inks and emissions in printing

If you use solvent-based inks, coatings and cleaning agents, printing carries duties beyond the factory floor: an air-emissions permit that controls volatile organic compounds, and your UK REACH duties on the hazardous substances in your inks and chemicals. This guide takes you through both.

Relevant to a specific activity in this sector.

Meet your environmental permit and emissions trading duties

If you run a cement, lime, glass or ceramics kiln or furnace, your installation needs an environmental permit, and cement, lime and glass production fall within the UK Emissions Trading Scheme. This guide takes you through the installation permit and your greenhouse-gas monitoring, reporting and allowance duties.

Relevant to a specific activity in this sector.

Which repair and installation regulations apply to your business

Repairing, maintaining and installing machinery and equipment shares a workplace-safety foundation, then adds a specific approval or certification for the systems you work on — gas, refrigeration and air-conditioning, pressure systems, aircraft or ships.

Relevant to a specific activity in this sector.

Manage environmental permits and water at your paper mill

Paper-making is water-intensive and tightly regulated for its discharges. A mill typically needs an environmental permit for the installation, a trade effluent consent for what it discharges to the sewer, and — if it takes water from a river or borehole — an abstraction licence. This guide takes you through all three.

Relevant to a specific activity in this sector.

Which basic metal manufacturing regulations apply to your business

Every basic-metal producer shares the same high-hazard workplace-safety foundation, then the rules diverge by scale, process and what you place on the market — whether you run a steelworks, a non-ferrous smelter, a foundry, or a nuclear-fuel processing site.

Relevant to a specific activity in this sector.

Which coke and petroleum manufacturing regulations apply to your business

Refining crude oil and making coke and other refined petroleum products is among the highest-hazard manufacturing there is, sitting inside the COMAH major-accident regime, environmental permitting and the UK Emissions Trading Scheme, with fuel quality standards and excise duty on top.

Relevant to a specific activity in this sector.

Which fabricated metal manufacturing regulations apply to your business

Every metal fabricator shares the same workplace-safety foundation, then the rules diverge by what you make and whether you place products on the market — from general fabrication to conformity-marked structural steel, pressure vessels, or firearms and ammunition.

Relevant to a specific activity in this sector.

Which furniture manufacturing regulations apply to your business

Furniture manufacturers share workplace-safety duties built around wood dust and finishing chemicals, then carry the furniture fire-safety and product-safety rules before anything reaches the market.

Relevant to a specific activity in this sector.

Which machinery and equipment manufacturing regulations apply to your business

Manufacturing machinery and equipment — engines, pumps, machine tools, lifting and handling equipment, agricultural machinery and industrial plant — shares a workplace-safety foundation, then carries a heavy set of product-conformity duties before anything reaches the market.

Relevant to a specific activity in this sector.

Which non-metallic mineral products manufacturing regulations apply to your business

Manufacturing glass, ceramics, cement, lime, plaster, concrete products and cut stone carries workplace-safety and respirable-silica duties, then diverges by whether you place construction or consumer products on the market and how energy-intensive your process is.

Relevant to a specific activity in this sector.

Which other manufacturing regulations apply to your business

Makers of jewellery, musical instruments, sports goods, games and toys, medical and dental instruments, brushes and other goods share a workshop-safety foundation, then carry the product-conformity regime that fits what they make — general product safety, toys, PPE, medical devices or hallmarking.

Relevant to a specific activity in this sector.

Which paper manufacturing regulations apply to your business

Making pulp, paper, board and paper products carries workplace-safety duties, a water-intensive environmental footprint, and product rules covering general product safety, food-contact materials and packaging producer responsibility.

Relevant to a specific activity in this sector.

Which printing and media reproduction regulations apply to your business

Printers and reproduction businesses — commercial, digital and screen printers, packaging printers, and reproduction of recorded media — carry workplace-safety duties and face extra environmental and chemicals obligations wherever they use solvent-based inks and cleaning chemicals.

Relevant to a specific activity in this sector.

Which rubber and plastic manufacturing regulations apply to your business

Every rubber and plastics manufacturer shares the same workplace-safety and chemicals foundation, then the rules diverge by what you make and whether you place products on the market or produce packaging.

Relevant to a specific activity in this sector.

Which wood products manufacturing regulations apply to your business

Sawmilling and making wood products — sawn timber and veneers, plywood and panels, joinery and packaging, cork and other wood goods — shares a workplace-safety foundation built around wood dust, then carries its own market rules: legal timber sourcing, construction-products marking, formaldehyde limits, general product safety and wood-packaging treatment.

Relevant to a specific activity in this sector.

Comply with work equipment safety regulations (PUWER)

How to meet your legal duties under the Provision and Use of Work Equipment Regulations 1998 (PUWER). Covers suitability, maintenance, inspection, guarding of dangerous parts, controls and emergency stops, training and information requirements. PUWER applies to all work equipment from hand tools to complex machinery.

Applies if you give your workers machinery, plant, vehicles or tools to use at work

Use mobile work equipment safely

How to comply with PUWER Regulations 25-30 for mobile work equipment such as forklift trucks, dumpers, excavators, and tractors. Covers roll-over protection, seatbelts, visibility, traffic management, and operator training.

Applies to some businesses in this sector – open the guide to check

UK REACH Chemical Compliance

Understand and comply with UK REACH chemical registration requirements for manufacturers and importers.

Relevant across several parts of this sector.

CLP Chemical Classification and Labelling

Classify, label and package hazardous chemicals under GB CLP.

Relevant across several parts of this sector.

COMAH Compliance for Chemical Sites

Meet COMAH requirements for sites holding dangerous substances.

Relevant across several parts of this sector.

Get the specialist approvals for the systems you repair and install

Some kinds of equipment can only be worked on under a specific approval or certification. If you install, service or repair gas appliances, refrigeration and air-conditioning, pressure systems, aircraft or ships, this guide takes you through the registration, certification and competence you need before you do the work.

Relevant to a specific activity in this sector.

Biocides and Pesticides Authorisation

Get HSE CRD authorisation for biocidal and pesticidal products.

Relevant to a specific activity in this sector.

Get authorisation for a water activity in Scotland (EASR)

How to get authorisation for any activity affecting surface water or groundwater in Scotland — abstraction, impoundment, engineering in or near a water body, and discharges. Since 1 November 2025 water activities are authorised under the Environmental Authorisations (Scotland) Regulations 2018 (EASR), which replaced the Controlled Activities Regulations (CAR 2011) framework. Covers the four-tier authorisation system (General Binding Rules, notification, registration, permit), pre-application advice, fees, and enforcement, all administered by SEPA.

Relevant across several parts of this sector.

Get a water discharge permit

How to get an environmental permit for discharging liquid effluent or waste water to surface water or groundwater. Covers standard rules and bespoke permits, groundwater protection, monitoring requirements, and the difference between environmental permits and trade effluent consent.

Applies if you release liquid effluent or waste water into a river, the sea or the ground

Trade effluent consent for discharging to sewers

How to get consent from your water company to discharge trade effluent into public sewers. Covers what counts as trade effluent, when consent is needed, how to apply, prohibited substances, consent conditions, charges, and enforcement under the Water Industry Act 1991.

Applies if you put process liquids, washwater or other non-household effluent down the drain into the public sewer

Apply for a water abstraction licence

How to apply for a licence to abstract water from rivers, streams, boreholes, or other sources. Covers the 20 cubic metres per day threshold, licence types, pre-application enquiries, Environmental Impact Assessment, annual charges, and devolved nation requirements.

Applies if you take water from a river, borehole, spring or well rather than the mains

Water abstraction licences and drinking water quality in Northern Ireland: NIEA and DWI

How water is regulated in Northern Ireland for two different kinds of business: a mill or other user that takes water from a river, lough or borehole and needs an abstraction and impoundment licence from NIEA, and a water undertaker that supplies drinking water and must meet the 2017 Water Quality Regulations enforced by the Drinking Water Inspectorate.

Relevant to a specific activity in this sector.

Environmental Permit - Part A(1) Installation

Large combustion plant (50MW thermal input and above) and other major industrial installations require a Part A(1) environmental permit.

Relevant to a specific activity in this sector.

Electronics and electrical product conformity: which regime applies

A quick-lookup reference for makers and importers of electronic and electrical products. Use the product features to find which conformity regime or regimes apply, the regulator, and whether the rule is a Great Britain or a UK-wide matter, then go to the linked snippet for the detail.

Relevant across several parts of this sector.

Chemical manufacturer: compliance checklist

A verification checklist for makers of chemicals and chemical products. Use it to confirm that UK REACH registration, GB CLP classification and labelling, product authorisation, COMAH duties, environmental permits, DSEAR controls, explosives licensing and core workplace health-and-safety duties are all in place before a production run.

Relevant to a specific activity in this sector.

Which chemical regulations apply to your products and site

A reference guide for chemical manufacturers that routes you to the regimes that apply to your products and your site. It points you to UK REACH and GB CLP for substances and mixtures, product authorisation for biocides, plant protection products and cosmetics, COMAH and environmental permitting for major-hazard sites, and the explosives licensing regime.

Relevant to a specific activity in this sector.

Place electronic and electrical products on the GB market: conformity assessment and UKCA marking

A guide for makers and importers of electronic and electrical products placing products on the GB market. It explains which conformity regimes apply to which products, the steps to assess conformity and apply the UKCA marking, and how the GB-scope safety regime differs from the UK-wide RoHS, WEEE, electromagnetic compatibility, radio and metrology regimes.

Relevant to a specific activity in this sector.

Place chemical substances and products on the GB market

A task guide for chemical manufacturers placing substances and products on the GB market. It covers UK REACH registration, GB CLP classification, labelling and packaging, and product authorisation for biocides, plant protection products and cosmetics, with the placing-on-market sequence in order.

Relevant to a specific activity in this sector.

Food-contact materials compliance in Scotland, Wales and Northern Ireland: councils, FSS and FSA rules

What paper, board and converting businesses must do to put food-contact materials on the market in Scotland, Wales and Northern Ireland. Each nation has its own 2012 Regulations, its own enforcers and its own penalty scale, and Northern Ireland applies EU food-contact law under the Windsor Framework, including the EU ban on bisphenol A.

Relevant to a specific activity in this sector.

Place fabricated metal products on the market: conformity and UKCA marking

If you make metal products to sell — structural steelwork, boilers and pressure vessels, or general metal goods — they must be safe and, where a product regime applies, carry conformity marking before you place them on the Great Britain market. This guide takes you through construction products and structural steel, pressure equipment, and the residual general product safety duty.

Relevant to a specific activity in this sector.

Place jewellery, toys, medical devices and other goods on the market

Every product you make carries its own conformity regime before it reaches the market. Most goods carry general product safety. Toys, personal protective equipment and medical devices have their own marking and registration rules. Articles of precious metal must be hallmarked. Work through the section that fits what you make.

Relevant to a specific activity in this sector.

Place basic metal products on the GB market: conformity and marking

If you place metal products on the market — structural steel and reinforcing steel for construction, or other finished metal goods — they must be safe and, where a product regime applies, carry conformity marking and a declaration of performance before you place them on the Great Britain market. This guide takes you through construction products and structural steel, and the residual general product safety duty.

Relevant to a specific activity in this sector.

Place non-metallic mineral products on the market

Cement, aggregates, concrete products, glass and ceramic building products are construction products and must meet the conformity rules before you sell them; other goods must still meet the general product safety duty. This guide takes you through construction-products conformity — declaration of performance and marking — and the residual product-safety baseline.

Relevant to a specific activity in this sector.

Place rubber and plastic products on the market: conformity and product safety

If you make rubber or plastic products to sell — plastic builders' ware, tyres, food-contact articles and packaging, or general plastic goods — they must be safe and, where a product regime applies, meet that regime and carry conformity marking before you place them on the market. This guide takes you through construction products, tyre safety, food-contact materials, and the residual general product safety duty.

Relevant to a specific activity in this sector.

Ongoing material duties for vehicle manufacturers: end-of-life recycling and restricted substances

A task guide for motor-vehicle manufacturers on the two ongoing material duties that continue beyond placing a vehicle on the market — end-of-life vehicle producer responsibility, and the restriction of chemical substances under UK REACH. Both are recurring duties to set up, not one-off checks.

Relevant to a specific activity in this sector.

Type-approve and place motor vehicles, trailers and components on the GB market

A task guide for makers of motor vehicles, trailers, bodywork and components placing product on the GB market. It covers whole-vehicle and multi-stage type-approval, component and separate-technical-unit (STU) approval, emissions and CO2 type-approval, and replacement-part safety, with the placing-on-market sequence in order.

Relevant to a specific activity in this sector.

Meet the furniture fire-safety and product-safety rules

Upholstered furniture and mattresses must meet strict fire-safety requirements before you can sell them, and all furniture must meet general product safety. This guide takes you through the Furniture and Furnishings (Fire) (Safety) Regulations 1988 — the ignition-resistance tests and the labelling — and the residual general product safety duty.

Relevant to a specific activity in this sector.

Place wood and wood products on the market

Before wood and wood products reach the market they carry their own rules: legal sourcing under the UK Timber Regulation, performance marking for construction products like structural timber and panels, formaldehyde limits on wood-based panels, general product safety for consumer goods, and heat treatment and marking for solid-wood packaging that travels abroad. This guide takes you through each in turn.

Relevant to a specific activity in this sector.

Vehicle Type Approval

Get type approval for vehicles manufactured or imported into GB.

Relevant to a specific activity in this sector.

Meet motor fuel quality and hydrocarbon oil duty

The fuels you make carry two duties beyond running a safe installation: they must meet the motor fuel quality standards for what can be supplied, and the mineral oils you produce are subject to hydrocarbon oil (excise) duty, with HMRC approval and accounting. This guide takes you through both.

Relevant to a specific activity in this sector.

Place paper products on the market

Before paper products reach the market they carry their own rules. Consumer goods must be safe under general product safety. Cartons, wrap and other food-contact paper and board must meet the food-contact materials rules. The packaging you place on the market brings extended producer responsibility duties. This guide takes you through each in turn.

Relevant to a specific activity in this sector.

Product safety compliance checklist for the GB market

Compliance checklist for businesses placing consumer products on the Great Britain market. Covers the general safety requirement, UKCA marking and documentation, traceability, supply chain roles, record keeping, and recall preparedness under the General Product Safety Regulations 2005, Consumer Protection Act 1987, and Product Regulation and Metrology Act 2025.

Applies if you make, import or supply finished goods that end up in consumers' hands

Assess whether your product meets the general safety requirement

How to carry out a product safety risk assessment to determine whether your product meets the general safety requirement under the General Product Safety Regulations 2005. Covers the OPSS PRISM methodology, designated standards, documenting your assessment, and building a due diligence defence.

Applies if you make, import or supply finished goods that end up in consumers' hands

Product standards and CE marking for the Northern Ireland market

How product standards and marking requirements differ for the Northern Ireland market under the Windsor Framework. Covers CE marking requirements, why UKCA marking is not valid in NI, the EU General Product Safety Regulation applying in NI from December 2024, and dual compliance obligations for businesses selling across the whole UK.

Relevant across several parts of this sector.

Construction product marking - CE and UKCA compliance

How the Construction Products (Amendment) Regulations 2025 affect CE and UKCA marking for construction products placed on the Great Britain market. CE marking continues to be recognised until further notice, and from 8 January 2026 GB also recognises products complying with the new EU Construction Products Regulation 2024/3110. UKCA marking remains voluntary. Covers Declarations of Performance, harmonised and designated standards, and OPSS enforcement.

Applies if you distribute or resell construction products made by others

Electrical product safety compliance

How to comply with the Electrical Equipment (Safety) Regulations 2016 when placing electrical products on the Great Britain market. Covers safety objectives, voltage scope, conformity assessment, technical documentation, UKCA and CE marking, EMC Regulations overlap, and RoHS requirements for electrical and electronic equipment.

Relevant across several parts of this sector.

UKCA 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.

Relevant across several parts of this sector.

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.

Relevant across several parts of this sector.

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.

Relevant across several parts of this sector.

Toy safety compliance in Great Britain

How to comply with the Toys (Safety) Regulations 2011 when placing toys on the Great Britain market. Covers essential safety requirements, age grading and warnings, chemical limits, conformity assessment routes, UKCA and CE marking, documentation obligations, and economic operator duties.

Relevant to a specific activity in this sector.

Medical devices and equipment compliance

Regulatory requirements for medical devices including vigilance reporting and equipment maintenance.

Relevant to a specific activity in this sector.

Placing 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.

Relevant to a specific activity in this sector.

Post-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.

Relevant to a specific activity in this sector.

Report 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.

Relevant to a specific activity in this sector.

Choosing 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.

Relevant to a specific activity in this sector.

Classify 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.

Relevant to a specific activity in this sector.

Software 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.

Relevant to a specific activity in this sector.