A competent authority plays a significant role in the continued development of your medical device, and they have the power to impose restrictions on your product. Field safety notices, field safety corrective action, and medical device alerts can all be initiated or implemented by a competent authority. At Patient Guard Ltd, in Blackpool, Lancashire, we help manufacturers register with a competent authority and cooperate with both parties when necessary to achieve the desired outcome. Clients also rely on us to act as a qualified person at their company.
For manufacturers of Class I devices, there is a requirement to be registered with an EU competent authority (CA), such as the MHRA. Patient Guard Ltd can perform this on your behalf, keeping you informed of any action required.
A field safety corrective action (FSCA) poses a challenge for a manufacturer, especially if a recall is required. Our consultants will help you work with the competent authorities in managing FSCAs as well as the associated regulatory issues that they may cause.
A field safety notice (FSN) is usually required by a manufacturer should an issue have occurred within the market, usually identified from the vigilance process and complaint handling. Although it can be something as simple as a change to your Instructions for Use (IFU), Patient Guard Ltd will help you to draft any FSNs and engage with you on your strategy
A medical device alert (MDA) is usually issued if the competent authority believes that the FSCA and/or FSN has not been effective in removing the risk to the end user, or your tractability is insufficient in warning your customers of the issue. Through this stressful time, Patient Guard Ltd will help you to plan your way forward.