New EU guidance provides guidelines for manufacturers of custom-made medical devices with a view to compliance with MDR rules.
The Medical Device Coordination Group (MDCG) has issued instructions clarifying the guidelines for manufacturers of custom-made medical devices in order to achieve a harmonised administrative practice for the interpretation of the rules set out in Regulation 2017/745 on Medical Devices (MDR).
The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The MDCG was established by Article 103 of MDR and is to provide advice to and assist the Commission and the Member States in ensuring harmonised implementation of the Regulations on Medical Devices.
What is a custom-made device?
Under MDR Article 2(3), "custom-made devices" are defined as any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. It is up to the individual Member State to define who is an "authorised" person.
Mass-produced devices are not considered custom-made devices. Further, adaptable medical devices and so-called "patient-matched" devices are not considered custom-made devices.
Parts and components from custom-made devices
Minor parts, components and similar material from custom-made devices may in themselves be approved as medical devices. Consequently, such minor parts may be supplied on the market. However, compliance with all manuals and similar from the manufacturer is a presumption when reworking a device, before the patient uses the device.
Manufacturers of medical devices comprised by minor parts must at all times comply with relevant and applicable MDR requirements. If during the processing the physical, chemical or biological properties of the device change, the final device must comply with the general safety and performance requirements that follow from Annex 1 to the MDR.
Manufacturers of medical devices comprised by minor parts also bear full responsibility for the device, which for instance includes post-market surveillance .
Obligations of manufacturers of custom-made devices
Manufacturers of custom-made devices are subject to largely all the requirements set out in MDR. The manufacturer must establish which safety and performance requirements set out in MDR Annex I apply to the relevant device. Further, the manufacturer must establish a quality management system, which must be continually maintained and improved. The main function of the system is to ensure compliance with MDR in the most suitable manner, in proportion to the type of risk of the medical device.
To be able to perform post-market surveillance, the manufacturer should establish suitable channels of communication for relevant healthcare professionals as well as for patients. This ensures that the manufacturer receives information about the quality, safety and performance of the device after launch.
Manufacturers must further report serious incidents or accidents involving the relevant device to the appropriate authorities.
Click here to read more about the guidance.