Reshaping EU Healthcare: Custom-made Medical Devices

The healthcare landscape in the European Union (EU) is changing, with substantial advances in medical technology resulting in more tailored and effective treatment alternatives. This transformation is centered on custom-made devices, patient-matched devices, and adaptable medical devices, which provide tailored solutions to individual patient needs. This blog dives into the intricacies of these devices, including their differences, custom-made devices' special needs, their conformity assessment procedure, and manufacturers' obligations.

What are Custom-made Devices?

Custom-made medical devices (CMDs) are designed and manufactured to meet the specific demands of an individual patient based on a detailed prescription from a medical practitioner, considering the patient's unique anatomical and physiological characteristics.

Examples of CMDs include:

• Dental appliances
• Prosthetic limbs
• Specific orthopedic implants.

What are Patient-matched Devices?

Patient-matched devices, also known as patient-specific or tailored devices, are created using conventional templates that allow for some sort of mass production but are adjusted to meet the specific patient’s needs. These devices are partially pre-fabricated before being customized to the specific demands of each patient.

Common examples include:

• Mandibular implants
• Plates used to fix a broken bone
• Cutting guides.

What are Adaptable Medical Devices?

Adaptable medical devices are mass-produced medical devices that 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 anatomical-physiologic features prior to use.

Examples of mass-produced adaptable medical devices may include:

• Certain spectacle frames and optical glasses
• Patient-fitted wheelchairs
• Hearing aids.

Difference Between Patient-matched/Adaptable Medical Devices and Custom-made Devices

What Requirements in the EU MDR Make Custom-made Devices Different from Other Medical Devices?

Custom-made devices are classified using a similar risk-based approach as per the EU MDR that includes invasiveness, intended use, and duration of use as other medical devices. Manufacturers of custom-made devices must provide a classification reason and details on why the device is classified as a CMD.

The key requirements include:

• Custom-made devices must be accompanied by a declaration/statement according to Annex XIII, Section 1 of MDR (MDR: Article 21, Paragraph 2). The associated user or patient must be identifiable by name, acronym, or numerical code (MDR: Article 21, Paragraph 2).
• The product and packaging must be labeled "custom-made device" (MDR: Annex I 23.2 and 23.3).
• Assigning or affixing Unique Device Identification (UDI) is not required (MDR: Recitals point 42, Article 27 paragraph 1, 3, Article 29 paragraph 1,2,4).
• No technical documentation is created. However, documentation according to Annex XIII, Section 2 is required (MDR: Article 10, paragraph 5).
• The competent authorities may require the manufacturer to provide them with a list containing all custom-made devices that have been placed on the market in the respective territory (MDR: Article 21, paragraph 2).
• The manufacturer, authorized representative, and importer do not have to register in the electronic system referred to in Article 30 (EUDAMED) (MDR: Article 30, paragraph 3; Article 31, paragraph 1).
• The PRRC also does not need to register in EUDAMED (MDCG 2021-3, Point 9).
• Unlike the usual practice, for custom-made devices, the PRRC's qualification can be demonstrated through two years of relevant professional experience in the manufacturing sector (MDR: Article 15, paragraph 1).

Note: Special considerations apply to Class III or implantable custom-made devices.

It must be underlined that products that are adaptable medical devices or patient-matched medical devices are not qualified as CMDs and must follow the ‘standard’ MDR regulatory pathway for placing on the market.

Conformity Assessment Procedure for Custom-made Devices

As per EU MDR requirements, all medical devices should comply with relevant general safety and performance requirements of MDR Annex I to ensure conformity.

• Collaboration with a notified body in the context of the conformity assessment is not necessary for Class IIa and IIb (MDCG 2021-3, Point 9).
• Manufacturers of Class III custom-made implantable devices shall be subject to the conformity assessment (such as notified body review). The manufacturer may choose to apply a conformity assessment route as specified (Article 52, paragraph 8).

Obligations of Custom-made Device 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 each individual CMD.

Custom-made devices, dental appliances, and prosthetic limbs mark significant advances in personalized healthcare, providing specialized solutions that improve patient outcomes. However, these advantages come with an array of regulatory and production issues that must be carefully managed to assure safety and compliance. To counter this, our experts at Freyr are equipped to assist you in conquering all your regulatory hurdles with ease.