Welcome to the devices industry area of the MHRA website. This section provides targeted links to information throughout the site that is relevant to manufacturers of medical devices.
The MHRA is the competent authority (CA) for the UK. On behalf of the Secretary of State for Health, we administer and ensure compliance with medical device legislation in England, Northern Ireland, Scotland and Wales. The MHRA meets its CA functions in the following ways:
- Enforces the regulations by:
- investigating allegations received about possible non-compliance with the regulations
- operating a proactive inspection programme where manufacturers are randomly selected for inspection by MHRA's own staff.
- Designates UK notified bodies and audits them.
- Investigates post-market surveillance reports received from medical device manufacturers and users.
- Maintains a register of certain types of manufacturers.
News and hot topics
The European Commission is looking for medical devices experts with at least six years of professional experience to work on policy, audits, inspections, and evaluation.
The MHRA is seeking views on its approach to implementing into UK law the Commission Regulations 722/2012 on animal tissues and Commission Regulation 207/2012 on e-labelling.
04 Apr 2013 | MHRA response to the public consultation on the revision of European legislation on medical devices
The MHRA has published its analysis of the evidence received from healthcare professionals, patients, industry, academics, and the interested public on the draft new European legislation on medical devices.