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Questions & Answers on MDR “Custom-Made Devices”

By: | Tags: | Comments: 0 | June 8th, 2021

 

What is a custom-made device?

MDR Article 2 (3) defines a „custom-made device“ as any device that:

  • is specifically made in accordance with a written prescription of any person authorized by national law by virtue of that person’s professional qualifications; which gives
  • specific design characteristics provided under that person’s responsibility and
  • is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

 

Examples can include devices made in accordance with a written prescription:

  • Hand prosthesis
  • An orthosis
  • Orthopedic footwear

 

Devices that are mass-produced which need to be adapted to meet the specific requirements of any professional user (“adaptable medical devices”) and mass-produced devices by means of industrial manufacturing processes, potentially made in accordance with the written prescriptions are not considered “custom-made devices” (for example: orthotic braces, patient fitted wheelchairs, optical glasses etc.)

 

What defines a written prescription containing patient specific design characteristics?

At minimum, a written prescription should contain:

  • the name of the patient (or pseudonym if relevant);
  • specific design characteristics made by the authorized 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);
  • molds (e.g. for dental or orthotic purposes);
  • dental impressions.

 

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 (such as the thickness and trajectory of a plate, the number, type and positions of fixation screws, choice of material) by the prescribing person is necessary as part of a written prescription in order for the definition of a custom-made device to be met.

 

How many “classes” are there for “custom-made devices”?

There are two categories of “custom-made devices”:

  • General “custom-made devices”
  • Class III implantable “custom-made devices”

 

Class III implantable custom-made devices must follow the procedure in Annex IX, chapter I (certification of the QMS).

 

Does a 3D printed device (additive manufacturing) qualify as a “custom-made device”?

A 3D printed device does not qualify as a “custom-made device” by default. An assessment should be performed on a case-by-case basis. In order for a 3D printed device to qualify as a “custom-made device”, the requirements from question 1 must be met.

 

Which obligations of “custom-made device” manufacturers differ from those of other medical device manufacturers?

  • MDR Annex XIII: the conformity assessment procedure applicable only to custom-made device;
  • Custom-made device shall be accompanied by the MDR Annex XIII statement;
  • No requirement for UDI registration, assignment and labelling;
  • A conformity assessment procedure covering QMS certification by a notified body is applicable to Class III implantable “custom made devices” and shall be entered in EUDAMED;
  • A person responsible for regulatory compliance (PRRC) is not required to register in EUDAMED;
  • A Summary of Safety and Clinical Performance (SSCP) is not required for a “custom-made device” (Article 32(1));
  • As for post-market surveillance, a report according to Article 85 MDR and a Periodic Safety Update Report (PSUR) according to Article 86 MDR, must be established by the “custom-made device” manufacturer;
  • In case of Class III implantable devices, PSURs are not required to be sent to notified bodies but must be part of the “custom-made devices” documentation.

 

more info provided at below references:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745

https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_2021-3_en.pdf

 

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