The Medical Device Regulation 2017/745 defines a ‘custom-made device’ as any device which is specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications. This authorised person gives specific design characteristics provided under their responsibility. Moreover, such a custom-made device would be exclusive to one specific patient to meet their individual conditions and needs.
Adaptable medical devices or patient-matched medical devices are not categorized as custom-made devices. Adaptable medical devices are mass-produced medical devices which are adapted, adjusted, assembled, or shaped at the point of care to suit the individual’s features. Patient-matched medical devices are matched to an individual’s anatomy within a specified design envelope, is typically produced in a batch through a process, and is designed and manufactured under the manufacturer’s responsibility even though its design may be based on a healthcare professional’s authorization.
General Obligations of the Manufacturer
Manufacturers of custom-made devices shall meet the following requirements of the Medical Device Regulation (MDR) 2017/745:
- Demonstration of conformity with the general safety and performance requirements,
- Conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF,
- Establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I,
- Implement and keep up to date the post-market surveillance system in accordance with Article 83. Establish a report for Class I devices according to Article 85 and a Periodic Safety Update Report (PSUR) for class IIa, IIb and III according to Article 86,
- Keep available documentation that indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture, and performance of the device, including the expected performance. Both the PMSR and the PSUR shall be part of this documentation.
- Set up a system for recording and reporting incidents and field safety corrective actions as described in Articles 87 and 88.
- Establish, implement, and maintain a quality management system (QMS) that shall ensure compliance with the MDR that is proportionate to the risk class and the type of device. The QMS must address all elements described in Article 10(9) of the MDR.
- Ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible, and clearly comprehensible to the intended user or patient.
Annex XIII Statement
In lieu of a Declaration of Conformity, manufacturers of custom-made devices shall draw up a statement as instructed in Annex XIII Section 1 which includes the following:
- the name and address of the manufacturer, and of all manufacturing sites,
- if applicable, the name and address of the authorized representative,
- data allowing identification of the device in question,
- a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code,
- the name of the person who made out the prescription and who is authorized by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,
- the specific characteristics of the product as indicated by the prescription,
- a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds,
- where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin, or of animal origin as referred to in Regulation (EU) No 722/2012.
This statement shall accompany each custom-made device and shall be made available to the particular patient or user identified by name, an acronym or a numerical code.
In addition to this statement, manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment as specified in Chapter I of Annex IX. Alternatively, the manufacturer may choose to apply a conformity assessment as specified in Part A of Annex XI.
PRRC
Manufacturers shall have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
Manufacturers of custom-made devices are not required to register their PRRC in EUDAMED.
Other obligations
Member States may require that the manufacturer of a custom-made device submit to the competent authority a list of such devices which have been made available in their territory.
Manufacturers who do not have a place of business in a Member State, may place their devices on the Union market if the manufacturer designates a sole authorized representative, as specified in Article 11 of the MDR.
Exemptions
- Manufacturers of custom-made devices are exempt from device UDI registration, assignment and labelling requirements.
- Manufacturers of Class III implantable custom-made devices are not required to send the PSURs to the Notified Bodies but they must be part of the documentation according to Section 2 of Annex XIII.
- Custom-made devices shall not bear the CE marking of conformity.
- Custom-made devices shall not be registered on EUDAMED.
- Manufacturers of Class III and implantable custom-made devices are not required to draw up a summary of safety and clinical performance.
