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
07 May 2014 | New restrictions on the use of certain hazardous substances in electrical and electronic equipment (RoHS) requirements
In June 2011, the recast of the RoHS Directive (2002/95/EC) was published in the Official Journal as Directive 2011/65/EU (RoHS II). One of the main requirements of RoHS II is to restrict six hazardous substances in electrical and electronic equipment.
19 Mar 2014 | Medical device stand-alone software (including apps)
The MHRA has today published guidance on medical device stand-alone software (including apps).
30 Jul 2013 | Proposal for new European regulations aimed at improving consumer product safety and the functioning of the European internal market through market surveillance
The Department for Business Innovation and Skills (BIS) have published a consultation seeking views on the European Commission's proposals for two new European device regulations.