This guidance is only relevant for healthcare institutions in Great Britain (England, Wales and Scotland). Information on the healthcare institution exemption applicable in Northern Ireland.
In-house manufacture refers to medical devices that are made in a healthcare establishment to be used for patients within that establishment.
A healthcare establishment is a body that provides care for patients and promotes public health (eg an NHS hospital).
You need to see separate guidance if you are manufacturing in vitro diagnostic (IVD) medical devices.
This guidance doesn’t cover independent dental practices that manufacture their own appliances.
This guidance outlines the minimum requirements that healthcare institutions must meet when performing in-house manufacture of medical devices. Manufacturers can choose to implement more stringent requirements (such as those outlined in the guidance document published for Northern Ireland) as long as the minimum requirements below are met.
Legal requirements
You need to follow the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for certain activities relating to the in-house manufacture of medical devices. Some activities fall outside the scope of the regulations.
The UK MDR 2002 specifies that the exemption is only applicable to in vitro diagnostic medical devices (IVDs). Although not specifically stated, this guidance within the Regulations applies to both IVDs and general medical devices, and the in-house manufacturing exemption can apply to all medical devices assuming the below guidance is followed.
You should consider if:
- the product is defined as a medical device or IVD
- the intended purpose has been finalised or if it’s too early in the development stages to know
- the establishment that makes or develops the particular device is defined as a manufacturer in line with the UK MDR 2002
- the device is being placed on the market in line with the UK MDR 2002
These regulations don’t apply if your device is only being used for patients within the institute it was made, even if the product is made in one part of a healthcare establishment. For example, if it is made in an NHS trust laboratory and moved to another part of the hospital, as this means you are not placing it on the market.
They also don’t apply for those who put together or adapt existing devices for their intended purpose, for example a surgeon assembling an orthopaedic implant.
Devices transferred between hospitals
A transfer refers to a sale, loan, hire, lease, gift, or any other type of legal transfer. You should follow the regulations if you’re a healthcare establishment and you manufacture medical devices with the intention of transferring them to another establishment.
As this means you are a manufacturer, you must ensure the medical device complies with the conformity and UKCA marking procedures.
The UK MDR 2002 may apply for joint ventures between multiple establishments, even if there is a third establishment created to place the device on the market.
The regulations don’t apply if your institution has a specialist research and development laboratory that has been commissioned by another institution. This would usually be to manufacture a product for specific clinical or research purposes, which are not commercial objectives.
Sterilisation of devices such as surgical instruments is also not covered by the regulations as long as there is no change of ownership or new procedure pack needed.
Clinical investigations
You must notify the MHRA before you carry out a clinical investigation of a medical device if you are manufacturing it within your healthcare establishment and are selling it for profit.
Contact the MHRA
Please direct any queries to [email protected]
