The Medicines and Healthcare Products Regulatory Agency (MHRA) is government agency that regulates pharmaceuticals , blood establishments, advanced therapy medical products and medical devices in the United Kingdom. Working under the Department of Health, the MHRA also incorporates the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD).
The agency formed following the merger in 2003 of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA), then in 2013 with the National Institute for Biological Standards and Control (NIBSC). Its activities include overseeing UK notified bodies, regulating clinical trials, monitoring compliance for medicines and medical devices, as well as offering technical and regulatory advice for these products.
Some of the most important European regulations for medical devices in the EU are:
- CONSOLIDATED Medical Device Directive (93/42/EEC)
- CONSOLIDATED Active Implantable Medical Devices Directive (90/385/EEC)
- View as web page
- Personal Protective Equipment Directive (89/686/EEC)
A full list of EU regulations can be found here.
- Website: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Medical Device Associations in the United Kingdom:
- Association for Clinical Biochemistry
- Association of British Healthcare Industries Limited (ABHI)
- Association of X-Ray Equipment Manufacturers (AXrEM)
- BioIndustry Association (BIA)
- British Healthcare Trades Association (BHTA)
- British In Vitro Diagnostics Association (BIVDA)
- British Medical Association (BMA)
- Dental Laboratories Association
- Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH)
- National Institute for Health and Clinical Excellence
- The Association of Contact Lens Manufacturers (ACLM)