Medical device concerns and MHRA compliance

The number of regulatory 'alerts' issued by the UK medical devices regulator jumped 71% in the last year. We consider how manufacturers can respond to concerns about a medical device, and steps to take to ensure compliance with the regulations.

The Medicines and Healthcare products Regulatory Agency (MHRA), responsible for the regulation of medical devices in the UK, has issued 29 'alerts' in the past year, compared with just 17 in the previous year. This increase is due to a number of factors, including an increase in self-reporting by manufacturers.

Any issue with the safety of a medical product should be reported to the MHRA. Guidance from the MHRA suggests that reportable circumstances include (but are not limited to) when a medicine causes side effects, when someone is injured by a medical device (either because its labelling or instructions aren't clear or because it has been broken or misused) or when someone receives the wrong diagnosis because of a medical device. A report can be made by anyone, including patients. Depending on the severity of the report, it will be investigated either by the MHRA directly, or by the manufacturer or a nominated medical specialist.

The Human Medicines Regulations 2012 require manufacturers to have systems in place to record and review any complaints received about a product, as well as an effective system for recalling medicinal products at any time. Any complaint relating to the product should be investigated by the manufacturer. If a defect is identified that could result in a recall or abnormal restriction on supply, the manufacturer should inform the MHRA, and an investigation will be carried out.

If the investigation determines that a recall of the faulty medicine or device is required, it will be the responsibility of the licence holder (usually the manufacturer) to ensure that the recall is carried out effectively, working closely with the MHRA and the Defective Medicines Report Centre (DMRC). The following issues can lead to a recall if they are not addressed:

• Problems with labelling or packaging
• Potential contamination of the product
• Health risks associated with the product. 

The MHRA may issue a safety alert to inform healthcare professionals and wholesalers of the identified problem.

For manufacturers, a side effect of any product recall is that there can be increased regulatory scrutiny and, in some circumstances, litigation. In order to comply with the Human Medicines Regulations, manufacturers should:

• Ensure that systems are in place to monitor and record complaints, and to ensure that appropriate investigations are carried out in a timely manner.
• When the need for a potential recall is identified, seek to understand the cause of the problem and remedy it quickly, to reduce the potential class of affected individuals.
• Before announcing the recall, ensure that there is a consistent approach to internal and external communications of the issue; any inconsistencies in information could lead to difficult questions if litigation is pursued.