Medical Devices
Medical Device Coordination Group Document MDCG 2021-3
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3.
Are there specific considerations/requirements which must be taken into
account by manufacturers of devices referred to in Question 2?
Manufacturers of devices referenced in question 2 shall fulfil all relevant and applicable
requirements of the MDR. To determine the risk classes of those products, it is necessary to
consider:
− the intended medical purpose of the final CMD, adaptable medical device or
patient-matched medical device;
− whether it is an implantable medical device (i.e. whether the part, component or
material is intended to be used in the manufacturing of an implantable CMD,
adaptable medical device or patient-matched medical device)
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;
− the risks related to the intended contact or interaction of the product as a part,
component or material in the final CMD, adaptable medical device or patient-
matched medical device with the patient’s body.
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If any of the physical, chemical or biological properties of those products referred to in question
2 change during the manufacturing of the CMD, patient-matched medical device or the
adaptation process of the adaptable medical device (e.g. plastics, metallic compounds, ceramic
fluids for crowns), compliance of the finished product with the general safety and performance
requirements of MDR Annex I has to be demonstrated.
It is important to note that the manufacturer must also demonstrate that these products do
not create unacceptable risks to the persons performing the relevant preparatory processing
(such as preparation, configuration, installation, assembly, adaptation or fitting) to the needs
of the patient prior to their use.
The clinical evaluation conducted by the manufacturer should focus on demonstrating the
clinical benefit related to the intended medical purpose of the products when used as parts,
components or materials of a custom-made devices, adaptable medical devices or patient-
matched medical devices.
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To perform a post-market clinical follow-up (PMCF), liaison with the authorised person
responsible for the issuing of the relevant written prescription, CMD manufacturers who have
utilised the part, component or material and persons adapting the final device is necessary.
Furthermore, the manufacturer of devices referred to in question 2 bears the responsibility
over these CE marked medical devices and is responsible for all incumbent MDR obligations
such as post-market surveillance activities and vigilance reporting for the parts, components
or materials.
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Implantable devices encompass those devices which are partially or wholly implanted. Please refer to Article 2(5) of the MDR for
the definition of an ‘implantable device’.
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In general, the risk class of the product is expected to be the same as the risk class of the final CMD, adaptable medical device
or patient-matched medical device. For example, if a part, component or material is specifically intended to be used for the
manufacture of a Class III implantable custom-made device, then that part, component or material would be classified as a Class
III implantable.
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For further clarifications on clinical evaluation for custom-made devices, please refer to question 8.