How to comply with legal requirements for medical devices
The guidance below outlines the steps that you need to follow to meet the legal requirements before your product can be released into the UK market.
The first step that you need to take is to determine if your product is actually a medical device, by definition a medical device is any physical instrument, appliance, apparatus, material, software or other article that is used alone or combined for people to diagnose, prevent, monitor and/or treat a disease, diagnose, monitor, treat, alleviate or compensate for injury or handicap, control conception or finally to investigate replace and/or modify the anatomy or a physiological process. If you are manufacturing anything that meets this definition, you must follow specific rules for your type of product and adhere to the essential requirements of patient safety.
If you are manufacturing a medical device, yu=ou must follow specific guidelines that align with your relevant directive. The rules and regulations fall under the Consumer Protection Act of 1987 which ensures that medical devices are acceptably safe to be used for their intended purpose.
Medical devices are given a classification ranked on the level of risk associated with them, therefore the products with the highest risk will be under stricter control, the classes are as follows:
- Class I - generally low risk
- Class IIa - generally medium risk
- Class IIb - generally medium risk
- Class III - generally high risk
Accessories to the medical devices are classified separately to the device itself, however excluding accessories to implantable devices, these all fall under the highest risk class/category.
Once you have established the risk level of your medical device, you will need to follow the conformity assessment route to prove that the medical device has met the requirements in its associated directives.
If you have concluded that your device falls into either Class II, IIb or III, or is in Class I and is sterile or has a measurement function, you will be required to contact a notified body who can carry out a conformity assessment for your classification.
The notified body will ensure that the manufacturers of the medical device comply with the specific regulations which include but are not limited to the manufacturing processes and the quality management system.
Class I medical devices will not need to go through a conformity procedure if they are non-sterile and also do not have a measuring function as these devices are generally considered as low risk. However, you must register a Class I device with MHRA.
You have to register all IVDs with MHRA. If your device is listed in Annex II or if it is a self-testing device, you will be required to contact a notified body.
Manufacturers must hold clinical data to support any claims made for all types of medical devices. This is to prevent misleading the patient or the customer.
You are required by law to inform MHRA if you are going to conduct a clinical investigation with at least 60 days notice before commencing your investigation.
Lastly, once a medical device has been approved for placement in the UK market, the manufacturer is required to monitor the product and need to report any serious incidents to a reliable and competent authority.