The MDCG issued a dedicated Questions & Answers on the most pertinent matters concerning custom-made devices, adaptable medical devices and patient-matched medical devices as regulated by the MDR – Regulation (EU) 2017/745. Below we present an extract from this helpful document, starting with some definitions and examples.
Definition: MDR Article 2(3)
‘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;
Example: A dental crown manufactured according to a written prescription provided by a dentist containing specific design characteristics for a particular patient’s individual condition.
Legal status: Manufacturers to follow MDR compliance path specific to custom-made devices; check Q8 and Q9 of the MDCG Guidance for further details.
Adaptable medical devices
Definition: are mass-produced medical devices which must be adapted, adjusted, assembled or shaped at the point of care, traditionally by a healthcare professional, in accordance with the manufacturer’s validated instructions to suit an individual patient’s specific anatomo-physiologic features prior to use.
Examples: certain spectacle frames and optical glasses (assembled together to form spectacles), orthotic braces, exo-prosthetics
Legal status: According to MDR art. 16(1), a person (e.g. healthcare professional) who adapts, adjusts, assembles or shapes an adaptable medical device for a particular patient is not regarded as a manufacturer, as long as the adaptation, adjustment, assembly and shaping does not modify the device in such a way that compliance with the applicable requirements may be affected or changes the intended purpose.
Manufacturer to follow the MDR compliance path.
Patient-matched medical devices
Definition: a medical device that meets the following requirements:
•it is matched to a patient’s anatomy within a specified design envelope using techniques such as scaling of the device based on anatomic references, or by using the full anatomic features from patient imaging; and
•it is typically produced in a batch through a process that is capable of being validated and reproduced; and
•it is designed and produced under the responsibility of a manufacturer even though the design may be developed in consultation with an authorized healthcare professional.
Example: Cutting guides used in procedures such as knee arthroplasties, or guides used for pedicle screw placement, that are made by 3D printing based on MR or CT data to match a specific patient.
Legal status: under the sole accountability of the manufacturer who is entirely responsible for the design, safety, performance and overall compliance of the device; to follow the MDR compliance path.
——–The MDCG Q&A———–
Q 5. Does a 3D printed device (additive manufacturing) qualify as a CMD?
A 3D printed device does not qualify as a CMD by default. An assessment should be performed on a case-by-case basis. In order for a 3D printed device to qualify as a CMD, the following requirements must be met:
−a written prescription, containing patient specific design characteristics, of an authorised person is in compliance with the requirements expressed below (see question 6),
−the manufactured device is intended for the sole use of a particular patient, exclusively to meet their individual conditions and needs,
−the device is not mass-produced.
Q 6. What defines a written prescription containing patient specific design characteristics?
A written prescription must be issued by a qualified person authorised by national law. At minimum, it should contain:
−the name of the patient (or pseudonym if relevant),
−specific design characteristics made by the authorised person which are unique to the patient’s anatomic-physiological features and/or pathological condition. The following (non-exhaustive) additions can accompany a written prescription and if so, also constitute specific design characteristics:
•models (physical or 3D model data).
•moulds (e.g. for dental or orthotic purposes).
Note: Dimensions and/or geometric parameters (such as DICOM files from CT scans) are not considered specific design characteristics on their own. Additional measured data or information by the prescribing person is necessary as part of a written prescription in order for the definition of a CMD to be met.
Q 9. Which obligations of CMD manufacturers differ from those of other medical device manufacturers?
The conformity assessment procedure for all types of CMDs is described in MDR Annex XIII. In accordance with section 1 of Annex XIII, and in place of a declaration of conformity, CMDs shall be accompanied by an Annex XIII statement. This statement shall be made available to the particular patient or user identified by a name, an acronym or a numerical code. A conformity assessment procedure covering QMS certification by a notified body (in accordance with Chapter I of Annex IX or Part A of Annex XI of the MDR) is applicable to Class III implantable CMDs.
According to Article 56 (5), the registration of QMS-certificates issued for Class III implantable CMD shall be entered into EUDAMED. In addition, manufacturers may have to comply with national requirements on the registration of economic operators and devices.
CMD manufacturers are exempt from device 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. In addition, Article 32(1) prescribes that a Summary of Safety and Clinical Performance (SSCP) is not required for a custom-made device. As for post-market surveillance, a report for Class I devices according to Article 85 MDR and a Periodic Safety Update Report (PSUR) for class IIa, IIb and III according to Article 86 MDR, must be established by the CMD manufacturer. Both the post-market surveillance report and the PSUR must be part of the CMD documentation according to Section 2 of Annex XIII of the MDR. In case of Class III implantable CMDs, PSURs are not required to be sent to notified bodies but must be part of the CMD documentation according to Section 2 of Annex XIII of the MDR.