Spotlight

How Custom-Made Medical Devices are Regulated in the EU

Custom-made medical devices (CMD) are treated differently from other medical devices within the EU Medical Device Regulation 2017/745 (MDR) and in some cases, the requirements and obligations incumbent on CMD manufacturers may be unclear. The below article intends to provide some clarity, or at the very least, collect all available information on how CMD products are regulated in the EU.

Qualification as a CMD and Classification

For a product to qualify as a custom-made medical device, it must first meet the definition of a medical device, as defined in Article 2(1) of the MDR. Following this, the manufacturer must ensure that the product meets the definition of a custom-made medical device, as indicated in the EU MDR 2017/745:

‘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;

Article 2(3), EU MDR

The key elements here are that the device must be produced to specification in accordance with a written prescription to meet a particular patient’s needs, and must not be mass-produced. For example, prescription contact lenses would not fall into the definition of a CMD as they are mass-produced. On the other hand, an implant that has been specifically manufactured in accordance with a prescription for a particular patient would be considered custom-made.

Guidance released by the EU Medical Device Coordination Group (MDCG), MDCG 2021-3, provides additional information on what may or may not be considered a CMD. It uses the term ‘adaptable medical device’ for those products which are mass-produced and then adapted, assembled, shaped, or adjusted to meet the requirements of a user. Such adaptable medical devices include patient-fitted wheelchairs, orthotic braces, hearing aids, and exo-prosthetics.

The guidance also uses the term ‘patient-matched medical devices’ which are devices usually manufactured in batches and that meet the following:

  • 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 authorised healthcare professional.

These definitions have been taken from IMDRF ‘PMD WG/N49 FINAL: 2018’. Once it has been determined to be a CMD, the manufacturer can use the classification rules in Annex VIII to categorise the device. However, unless this is a Class III implantable CMD, this classification process will have little impact on the route to compliance.

Conformity Assessment Procedure

Article 52 of the MDR indicates that custom-made medical devices shall follow the conformity assessment procedure in Annex XIII and draw up the statement as required in that Annex, prior to placing the device on the market. In addition to this, Class III implantable CMDs will be subject to either the conformity assessment as specified in Chapter I of Annex IX or Part A of Annex XI, as decided by the manufacturer.

Annex XIII

CMDs have their own specific conformity assessment procedure, as found in Annex XIII of the EU MDR. This Annex requires manufacturers to:

  • Draw up a statement in accordance with the specific requirements in Annex XIII (1). This statement shall be kept for 10 years, or 15 years (for implantable CMD) after the device has been placed on the market.
  • Draw up, keep, and maintain technical documentation for the CMD.
  • Carry out and analyse data related to the CMD in the post-market phase.
  • Carry out vigilance-related activities and reporting, when applicable.

Technical Documentation

In Article 10, the MDR requires all devices, except for CMD, to draw up and keep up to date technical documentation, as set out in Annexes II and III. Article 10(5), requires that CMD have technical documentation drawn up in accordance with Section 2 of Annex XIII which states:

The manufacturer shall undertake to keep available for the competent national authorities 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, so as to allow assessment of conformity with the requirements of this Regulation.

Therefore, it is clear that the technical documentation for CMD does not need to be the same as that for other medical devices. However, Section 2 of Annex XIII is not specific as to what technical documentation is required for custom-made medical devices; the requirements in this section only point to what information shall be provided within the documentation. Therefore, the technical documentation must contain 3 main elements which clearly indicate the CMD:

  • Design.
  • Manufacture.
  • Performance.

In addition to these, the MDR provides hints throughout its text of other documentation which should be included:

  • General Safety and Performance Requirements (Annex XIII (1)).
  • Risk Management.
  • Post-Market Surveillance Report (Class I CMD).
  • Periodic Safety Update Report (PSUR) (Article 86).***
  • Clinical Evaluation Report (CER)(Article 61(12))*.
  • Post-Market Surveillance Plan (PMS Plan)(Article 84).**
    • PMCF shall also be part of this Plan.

*Article 61(12) states “The clinical evaluation, its results and the clinical evidence derived from it shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device concerned.” Our interpretation of this is that the Clinical Evaluation Report is still required, however, unlike other devices, it will not form part of the technical documentation referred to in Annex II.
** Similarly, Article 84 states “For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.”
*** The PSUR will not need to be provided to the Notified Body in the case of Class III implantable CMDs.

Class III implantable CMDs are not required to draw up a Summary of Safety and Clinical Performance (SSCP).

Person Responsible for Regulatory Compliance

Custom-made medical device manufacturers will also require a Person Responsible for Regulatory Compliance (PRRC). However, as a deviation from the requisite expertise/qualifications required in Article 15, CMD manufacturers may demonstrate the requisite expertise by having at least two years of professional experience within a relevant field of manufacturing. This PRRC will not need to be registered on EUDAMED.

Labelling and CE Mark

Custom-made devices will not require a CE mark and must clearly specify on their label that the product is a “custom-made device”. The device must be accompanied by the Annex XIII statement.

UDI and Registration

Unlike other medical devices, CMDs will not require a Unique Device Identification (UDI), as indicated in Article 27, and will not require registration on EUDAMED. In addition, CMD manufacturers do not seem to be required to submit an Actor Registration through Eudamed, as evident in Article 31. In light of this, Article 21 states that Member States shall not create obstacles to “custom-made devices being made available on the market if Article 52(8) and Annex XIII have been complied with”.

Obligations of CMD Manufacturers

Apart from the stated exceptions within the EU MDR for custom-made devices, obligations that need to be met by CMD manufacturers are the same as for other devices. This means that all CMD manufacturers must operate a Quality Management System (QMS) in accordance with Article 10(9). Risk management, post-market surveillance, and clinical evaluation requirements may be met for devices with a similar design, materials, and intended purpose, rather than for each and every CMD.

Additional Considerations

EU Member States are empowered to request a CMD manufacturer to provide them with a list of devices that have been made available in their country. Therefore, the manufacturer must ensure they keep a register of such devices with an indication of where the device has been sold, and to whom. Therefore, identification and traceability of the devices are also important aspects to consider, even though UDI may not be required.

How We Can Help

The following is a non-exhaustive list of services that we can provide to help you comply with the EU Regulation’s requirements for custom-made medical devices:

Get in touch today for a free initial consultation.