MDR requirements for custom-made medical devices
The Medical Devices Coordination Group (MDCG) established under Article 103 of Regulation (EU) 2017/745 published in March 2021 recommendations regarding the qualification of adaptable mass-produced medical devices, custom-made devices (CMD) and their components.
What is a custom-made device (CMS)?
Due to Article 2, section 3 of The European Regulation 2017/745 (MDR), a custom-made device defines a device made for a specific patient, in accordance with a medical prescription issued by an authorized person – a specialist doctor, e.g. an orthopedist or dentist. This product has special design properties, specially adapted and intended to be used only by a given patient in order to treat his diseases or to meet individual needs.
An example of a custom-made product is a dental crown, an orthosis, a lower limb prosthesis, or an orthopedic insole.
The following products are not considered as custom-made devices
- mass-produced products that need to be adapted to meet the special requirements of the professional user,
- mass-produced products using industrial production processes in accordance with medical orders of authorized persons.
What are medical devices adapted to meet the specific requirements of any professional user?
Medical devices adapted to the requirements of a professional user are mass-produced, they must be properly fitted, adjusted and assembled by a qualified specialist based on the manufacturer’s instructions. A given group of products may include, among others: hearing aids, wheelchairs, optical glasses.
What are medical devices made in accordance with medical orders of authorized persons?
Mass-produced products using industrial production processes in accordance with medical orders of authorized persons have the following properties:
- are adapted to the patient’s anatomy,
- are manufactured in a batch, in a way that allows for repeatability of production,
- are designed and manufactured under the responsibility of the manufacturer, while the product design may be consulted with a specialist in a given medical field,
- the use of products does not require an order from an authorized person.
A given group of products may include, among others: implants made in 3D technology, series-produced contact lenses according to special recommendations.
Manufacturers of mass-produced medical devices must carry out an appropriate conformity assessment procedure and label the devices with the CE mark.
Are the parts, components or materials specifically intended for use in a custom-made device are medical devices in accordance with Regulation 2017/745?
In accordance to Article 2 point 1 the intended use of a medical device may be achieved alone or in combination with other devices. Some parts, components and materials produced in series may have a medical purpose and therefore meet the definition of a medical device. To sum up, intermediates specifically intended for the production of custom-made devices, which are a component of the final product (ultimately adopted to the individual patient), should have the status of a medical device and be CE marked.
What are the obligations of manufacturers of custom-made devices?
The manufacturer of custom-made devices is obliged to implement the procedure for custom-made devices in accordance with Annex XIII of the Regulation (EU) 2017/745, but does not label the products with the CE mark. As in the case of mass-produced medical devices, it is required to fulfill the registration to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
What are the differences between the requirements of the MDD and the MDR regarding to custom-made devices?
Manufacturers of custom-made devices must face a significant change introduced by the New Regulation 2017/745 (MDR), which is post-market surveillance. The new regulations introduce an obligation to perform clinical observations after placing on the market and implement appropriate measures to apply all necessary corrective actions.
[1] MDCG 2021-3 MDCG Guidance concerning custom-made medical devices