The European Commission’s (EC) Medical Device Coordination Group (MDCG) has recently released a Q&A document covering the most pertinent questions that arise from the regulation of custom-made medical devices under the European Union Medical Device Regulation (EU MDR).
The first question outlines the scope of the legislation. It defines a custom-made device (CMD) as any device that is specifically made in accordance with a written prescription from an authorised person with specific design characteristics and is intended for the sole use of a particular patient to meet their individual conditions and needs. Examples include dental crowns, orthosis and prosthesis designed specifically for a particular patient. Mass-produced devices that are adapted to meet the specific requirements of a particular user are not consider to be CMDs.
Another key focus revolves around whether parts, components or materials specifically intended for use in a CMD, adaptable medical device or patient-matched device impacts are placed on the market as medical devices or CE marked. These ‘intermediate products’ can be placed on the market as standalone products, and when used in the construction of a CMD, the instructions from the manufacturer of the intermediate product should be followed. CMD manufacturers must consider whether the physical, chemical or biological properties of intermediate products are changed during the creation of a CMD. It must also be demonstrated that there is no danger to the end user or to the individual preparing the CMD during the process of adapting an intermediate product. Furthermore, manufacturers of an intermediate product are required to consider the intended purpose of the final CMD, whether it is implantable and the risks related to the intended interaction of the product as an element in the final CMD. The final question in the document clarifies this aspect of using CE marked intermediate products and the impact of this on MDR compliance.
State of the art industrial manufacturing processes (including 3D printing) can be used to manufacture CMDs as long as they still qualify based on the definition provided in the first question. As long as these techniques are not used to mass produce devices and are used for a particular design to meet a specific patient’s needs, then they can be used. It is also important to note that the use of 3D printing (additive manufacturing) doesn’t automatically qualify a device as a CMD.
Further questions provide clarity on the written prescription and authorised person described in the definition of a CMD. A written prescription must be issued by a qualified person authorised by national law. It must contain the name of the patient and the specific design characteristics created by the authorised person and which are unique to the patient’s anatomic-physiological features and/or pathological condition. The qualified person authorised by national law doesn’t have to be a healthcare professional and can be any person authorised by national law. Consequently, Member States are responsible with establishing who qualifies as an authorised person.
Later questions also define the obligations of CMD manufacturers in relation to the MDR. The majority of MDR requirements must be met and this includes establishing and maintaining a compliant quality management system (QMS), a post-market surveillance system and ensuring the reporting of any serious incidents and/or field safety corrective actions. However, certain obligations for CMD manufacturers differ from regular device manufacturers. Rather than a declaration of conformity as would normally happen with a regular device, a statement that comes with the CMD shall be provided to the patient in accordance with Section 1 of Annex XIIII of the MDR. However, a conformity assessment procedure covering QMS certification by a notified body is applicable to class III implantable CMDs, and such a certificate must be entered into EUDAMED. Despite this, CMD manufacturers are exempt from device UDI registration, assignment and labelling requirements.
To view the full Q&A document, click here.