Medical Devices

Medicines licensing Pharmacist and technician responsibilities Pharmacy premises standards Safe dispensing practices
Contents hide
1 Legal Definition
2 Regulation in the UK
3 UKCA and CE Marking
4 Classification of Medical Devices
4.1 Risk classes
5 Types of Devices
6 Software and AI as Medical Devices
7 Supply in Pharmacy
8 Legal Responsibilities for Pharmacies
9 Interaction with Medicines Law
10 Practical Risks for Pharmacies
11 Key Takeaways

Medical devices are regulated separately from medicines and are subject to a distinct legal framework in the UK. It is important to understand what qualifies as a medical device, how devices are classified, and the regulatory requirements that apply to their supply and use. Legal Definition Under the Medical Devices Regulations 2002 (SI 2002/618) (as…

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