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MDCG addresses custom devices under MDR

Posted 15 March 2021 | By Michael Mezher 

MDCG addresses custom devices under MDR

The European Commission’s Medical Device Coordination Group (MDCG) on Monday issued a new questions and answers document addressing custom-made medical devices under the Medical Device Regulation (MDR) and providing considerations for adaptable and patient-matched devices.
 
Custom-made devices (CMDs) are defined under MDR as devices made specifically in accordance with a written prescription by an authorized person that have specific design characteristics and are intended for the sole use of a particular patient to address their individual condition and needs.
 
Some examples of CMDs include dental crowns or hand prostheses made with specific design characteristics for an individual patient. Mass-produced devices that are adaptable to meet the requirements of professional users (adaptable devices) and those that are made via industrial manufacturing processes in accordance with a written prescription (patient-matched devices) are not considered CMDs and must follow the standard pathway for being placed on the market under MDR.
 
One of the major issues addressed in the Q&A document has to do with the use of parts, components or materials specifically intended to be used in a CMD, adaptable device or patient-matched device and the implications of whether those parts, components or materials are CE-marked or placed on the market under MDR.
 
“The intended purpose of a medical device can be achieved either alone or in combination with other devices or products. Certain parts, components or materials may carry a medical intended purpose and can thus fulfill the definition of a medical device. By analogy, parts, components or materials of custom-made devices, adaptable medical devices or patient-matched devices may be CE-marked medical devices,” MDCG writes.
 
MDCG also clarifies that such “intermediate products” may be placed on the market on their own. “Instructions for use provided by the manufacturer of these CE marked devices should be followed when performing further preparatory processing, preparation, configuration, installation, assembly, adaptation or fitting in order to meet the needs of the user or patient prior to their use,” MDCG adds.
 
Manufacturers of intermediate products are instructed to consider the intended purpose of the final device, whether the final device is implantable, and the risks related to the intended contact or interaction of the product as part of a final CMD, adaptable device or patient-matched device and a patient’s body when determining the risk class of such products.
 
Other considerations for intermediate products include whether the physical, chemical or biological properties of the product change during the manufacturing or adaptation of the CMD, patient-matched device or adaptable device and whether the products pose any risks to the persons performing the preparatory processing of the intermediate device.
 
The Q&A also addresses whether state of the art industrial manufacturing processes can be used to manufacture CMDs and whether 3D-printed devices can qualify as custom-made.
 
“As long as the definition of a CMD is fulfilled … and the device is not mass-produced, manufacturers may use modern state of the art technologies (such as CAD CAM, 3D-Printing etc.) to manufacture CMDs,” MDCG writes. With regard to 3D printing, MDCG explains that 3D-printed devices are not considered custom by default and must be made in accordance with a written prescription, be intended for the sole use of a particular patient and not be mass-produced.
 
The document also explains that to fulfill the requirements for a CMD, a written prescription must be issued by a qualified person authorized under national law and contain the name of the patient and specific design characteristics made by the authorized person unique to the patient’s anatomic-physiological features and/or pathological condition. Models, molds and dental impressions may also accompany a written prescription and constitute specific design characteristics.
 
MDCG notes that it is up to national law to determine what professions qualify as authorized persons in any given jurisdiction.
 
The document also clarifies some of the obligations of CMD manufacturers under MDR.
 
“With the absence of stated exceptions, CMD manufacturers must meet nearly all of the MDR requirements. Although the authorised person issuing the written prescription primarily determines the design and intended purpose of the CMD, it is the responsibility of the CMD manufacturer to consider which MDR Annex I requirements are applicable to the device at hand,” MDCG writes. Those requirements include establishing and maintaining a quality management system (QMS) proportionate to the risk class of their device, implementing an MDR compliant postmarket surveillance system and reporting serious incidents and field safety corrections to the competent authorities.
 
The conformity assessment procedure for CMDs is found in MDR Annex XIII and rather than a declaration of conformity, CMDs must be accompanied by an Annex XIII statement and shall be made available to the patient or user of the device. The conformity assessment procedure covering QMS certification is applicable to Class III implantable CMDs, which shall be entered into Eudamed. There may also be national requirements for manufacturers to register their devices or themselves as economic operators.
 
“CMD manufacturers are exempt from device [unique device identifier] UDI registration, assignment and labelling requirements. As such, and although they must appoint a person responsible for regulatory compliance (PRRC) in accordance with Article 15 of the MDR, they are not required to register these persons in Eudamed,” MDCG adds.
 
The document also addresses requirements for periodic safety update reports (PSUFs) for different classes of CMDs and discusses the implications of using non-CE marked devices as part of a CMD.
 
MDCG

 

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