in Buying Guide
Who Regulates the Sale of Surgical Instruments?
Who Regulates the Sale of Surgical Instruments?
Although companies are monitored by notified bodies, such as SGS (www.sgs.com), ultimately, the government monitor all medical devices in the field. Their role is as follows:
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
The MHRA does not see any medical device as risk-free. Ultimately, they have to ensure that for any product used by or on a patient, the risk outweighs the benefits. They monitor the medical devices out in the field and act if there is a risk to patient safety. Publishing any safety notices on their web site, to make product information freely available.