New Guidance Document related to Custom-Made Devices
MDCG 2021-3: Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices
This guidance addresses some of the bigger questions related requirements for Custom-Made devices under the MDR, such as:
The definition of a custom-made device (CMD)
The guidance references MDR Article 2(3)* for the CMD definition, but also underlines some key phrases within that definition that are important when determining if your product is a CMD. The guidance also provides some examples for products considered and not considered CMDs.
*‘custom-made device’ means 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.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;
The definition of adaptable and patient-matched medical devices
The differences outlined in ‘adaptable’ and ‘patient-matched’ medical devices is important. This is because adaptable and/or patient-matched devices must follow the full MDR compliance pathway, and obtain CE Marking. This is unlike CMDs, which are not CE Marked.
Examples of adpatable devices are:
• patient fitted wheelchairs
• hearing aids (otoplastic and amplifier)
• orthotic braces
Does the ‘authorised person’ writing the prescription for a CMD have to be a healthcare professional?
No, the MDR explicitly states that it should be any person authorised by national law. It is up to the Member States to establish who qualifies as an authorised person.
What are the obligations of a CMD manufacturer under the MDR and how do they differ from other medical device manufacturers?
CMD manufacturers must meet almost all MDR requirements, and it is the responsibility of the manufacturer to determine which requirements are applicable to their device. For example, the obligations related to QMS, post-market surveillance, risk management and the clinical evaluation life cycle must all be met by the CMD manufacturer.
There are some differences in the conformity assessment procedures between CMDs and other medical devices. The process for CMDs is noted in MDR Annex XIII. Further, CMD manufacturers are exempt from some requirements, such as UDI registration and certain labelling requirements. More information on this is noted in the Guidance
While we have summarized some key points above, the Guidance provides many additional details to help CMD manufacturers navigate the regulatory process under the MDR. Therefore, it is worth reading if this applies to your products.