What we regulate

Medicines and medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medicines and medical devices and equipment used in healthcare, and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.

Medicines

Whether it is a medicine you buy, or one prescribed for you as part of a course of treatment, it is reassuring to know that all medicines available in the UK are subject to rigorous scrutiny by the MHRA before they can be used by patients. This ensures that medicines meet acceptable standards on safety, quality and efficacy.

But what is, and is not, a medicine?
The law defines a medicine as something used in disease, whether it is used to prevent, treat or diagnose it, in anaesthesia, investigating conditions or interfering with the normal operation of the body. It does not include such things as contact lens fluids, food supplements and cosmetics.

Many factors are considered in deciding whether a product is actually a medicine such as what it contains, what it’s advertised or used for, the way it will be used, any particular targeting of the marketing information and what the promotional literature says.

Claims that a product 'supports' health or a healthy lifestyle is not usually considered as medicinal. Control of medicines starts as soon as they are first discovered and tested in healthy volunteers, all the way through to when a company wants to change the conditions its products are approved for, such as changing the colour of the tablet or what it is used for.

Go to information on how we regulate medicines

Devices

What is, and is not, a medical device?

The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability. The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products - many thousands of items used each and every day by healthcare providers and patients.

The list of items here is not comprehensive but shows the wide range of products that are considered to be medical devices:

General
  • Anaesthetic equipment
  • Blood warming cabinets
  • Catheters (for example, urinary, cardiac)
  • Chiropody equipment
  • Dental equipment and materials
  • Dressings
  • Endoscopes
  • Examination gloves
  • Implants - powered and non-powered (e.g. implantable defibrillators, pacemakers, heart valves, orthopaedic prostheses, bone cements)
  • IV administration sets and pumps
  • Ophthalmic equipment
  • Patient monitoring equipment (e.g. cardiac monitors)
  • Physiotherapy equipment
  • Radiotherapy equipment (brachytherapy external beam)
  • Sphygmomanometers
  • Surgical instruments and equipment
  • Syringes and needles
  • Thermometers
  • Vaginal specula
  • X-ray systems, ultrasound imagers and CT/MR scanners
For patient transportation or moving (but not including ambulance vehicles themselves):
  • Carry chairs
  • Lifting aids
  • Stretchers and trolleys
For critical care:
  • Defibrillators
  • Resuscitators
  • Ventilators
For people with a disability:
  • Orthotic and prosthetic appliances
  • Patient hoists
  • Pressure relief equipment
  • Walking aids
  • Wheelchairs and special support seating
For daily living:
  • Hearing aids
  • Incontinence products
  • Prescribable footwear
  • Special chairs
  • Urine drainage systems
Medical devices and equipment also include the following in vitro diagnostic medical devices and their accessories:
  • Blood gas analysers
  • Devices for blood glucose measurement
  • Hepatitis and HIV test kits
  • Pregnancy test kits
  • Specimen collection tubes
  • Urine test strips
Also included are:
  • Condoms
  • Contact lenses and care products
  • Intra-uterine devices (IUDs)

We are also interested in products which, whilst not themselves medical devices, are used closely in conjunction with these devices.

For example:

  • Bench top sterilizers
  • Blood and tissue storage systems
  • Chemical and biological indicators used in sterilization processes
  • Disinfecting and sterilizing equipment

Medical devices do not include ambulance vehicles, general workshop equipment such as power or machine tools, or general purpose laboratory equipment. Pre-filled devices, for example, drug inhalers, syringes and certain other drug/device combinations are classed as medicines, not medical devices, and should be reported via the Yellow Card scheme. The MHRA Adverse Incident Centre staff will be happy to provide advice in any cases of doubt.

Go to information on how we regulate devices

Advanced therapy medicinal products

Advanced Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial process.

Specifically, an ATMP is a medicinal product which is either a gene therapy medicinal product, a somatic cell therapy medicinal product or a tissue engineered product.

Under the ATMP Regulation, the Centralised authorisation procedure will apply to ATMPs which are intended to be placed on the market in the Community. A new committee, the Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA).

The CAT is responsible for preparing a draft opinion on the quality safety and efficacy of each ATMP for which a marketing authorisation application is submitted. The CAT’s opinion will be submitted to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for final approval.

Further information is available on the EMA’s website (external link)

In the UK, the MHRA is the supervisory authority for UK manufacturers or importers of centrally authorised ATMPs, as well as the competent authority for ATMPs which are prepared and used under the hospital exemption and made and supplied under the ‘Specials’ scheme.

The MHRA is also the competent authority for the assessment of applications for clinical trial authorisations and the associated manufacturer’s licence for investigational ATMPs.

Go to information on how we regulate advanced therapy medicinal products

Blood

The MHRA is responsible for regulating blood establishments and hospital blood banks. Statutory Instrument 2005 No. 50 and its Amendment (SI 2005/2898) about blood safety and quality became effective from 8 November 2005.

The Regulations set the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components.

The Principal Regulations require and provide for:

  • Blood establishments (primarily the national blood services of England, Wales, Scotland and Northern Ireland - the “UK Blood Service”) to be authorised and inspected, a process very similar to the existing arrangements operated by the MHRA under the Medicines Act.  The Regulations define a blood establishment as an organisation which collects and tests blood and blood components, whatever their intended purpose; and processes, stores and distributes blood and blood components when they are intended for transfusion.
  • Hospital blood banks to establish systems for quality management and haemovigilance1 and the MHRA to have powers to monitor compliance. A hospital blood bank is defined in the Regulations as any unit within a hospital which stores and distributes and may perform compatibility tests on, blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities. The Regulations do not require authorisation or routine inspection of blood banks. However, inspections of blood banks “for cause” may be carried out by the MHRA. Blood banks or blood establishments that are operating as blood banks are required to submit an annual return to the department setting out how they comply with the requirements of the Regulations.
  • Blood establishments and hospital blood banks to report to the MHRA  any serious adverse events or serious adverse reactions related to blood and blood components.

1 Haemovigilance comprises a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients and the epidemiological follow-up of donors.

Go to information on how we regulate blood


 


Page last modified: 30 May 2014