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The field of Drugs and Medical Devices Law in the United Kingdom covers the regulation of drugs, medical devices, and procedures. These laws apply to pharmaceutical companies, hospitals, private and public health providers, and individuals in the sector. Essentially, it provides a framework for the development, manufacturing, marketing, selling, and distribution of drugs and medical devices. In London, this sector of law is regulated by both UK and European Union regulations.
Legal advice in the field of Drugs and Medical Devices may be required in a wide range of situations. Businesses may need a lawyer to help with the regulatory process, ensuring all products comply with the relevant UK and EU regulations. Individuals may need legal guidance if they have suffered harm as a result of a pharmaceutical product or medical device, in which case a lawyer would help them understand their rights and possibly file a personal injury claim. Other aspects where legal advice may be needed include patent issues, licensing, clinical trials, and liability claims.
In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) supervises the safety and efficacy of drugs and medical devices. With regards to medical devices, the Medical Devices Regulations 2002 and various amendments provide a framework for their governance. Licensing, marketing, post-market surveillance, clinical investigations and in vitro diagnostic devices all fall under this umbrella. For medicines, the Human Medicines Regulations 2012 covers similar aspects.
A medical device is anything used for diagnosis, prevention, monitoring, treatment or alleviation of a disease, injury or handicap; investigation, replacement or modification of the anatomy or physiological process; or control of conception.
Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK, ensuring their safety and efficacy for patients and healthcare professionals.
A new drug approval in the UK follows several steps, including discovery and development, preclinical research, clinical research, FDA review, and post-market safety monitoring. The approval process usually takes several years.
Yes, if a drug has caused you harmful effects that you were not warned about, you may be able to bring a product liability claim against the manufacturer.
Following Brexit, the UK now has the option to diverge from EU regulations. However, the extent and timing of any changes are yet to be determined. Certain aspects, like the new UK Conformity Assessed (UKCA) mark which replaces the EU's CE mark, have already come into play for medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the best resource for all legal issues regarding Drugs & Medical Devices. They provide guidelines and regulations, information about licenses and trials, safety alerts and recalls, and other relevant information.
If you need legal assistance for Drugs & Medical Devices issues in the UK, it's critical to seek advice from a lawyer who specialises in this area. You can search for a suitable legal practitioner via The Law Society, which offers a “Find a Solicitor” service. Alternatively, local Citizens Advice Bureaux can also offer preliminary help and advice.
