European Regulators Publish New Q&A on Custom-Made Medical Devices

The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance.

The new MDCG Q&A document identifies 10 key questions pertaining to which devices qualify as custom-made devices, or CMDs, as well as MDR-related obligations and compliance considerations manufacturers will need to address.

Below, we discuss some of the CMD-related issues covered in the MDCG Q&A.

Defining a custom-made device under the MDR

First, the MDCG cites MDR Article 2(3) for defining a CMD as any device that has been produced according to a specific prescription from a qualifying physician or other qualified person; the prescriber sets specific design characteristics for the device, which is intended solely for use by a specific patient to meet their individual conditions and treatment needs.

Examples of devices qualifying as CMDs under the MDR include dental crowns designed for individual patients, knee ankle foot orthoses (KAFOs) featuring design characteristics specific to individual patients’ conditions, and prosthetic devices prescribed to replace lost body parts or functions using patient-specific design characteristics.

Mass-produced and patient-matched devices

The MDCG Q&A document also provided examples of devices that do not meet the MDR’s CMD definition.

• Any mass-produced device adapted to specific patient requirements post-production do not fall under the MDR definition for CMDs. Examples of mass-produced adapted devices include spectacle frames and optical glasses, patient-fitted wheelchairs, hearing aids and orthotic braces.
• In addition, the MDR’s CMD definition excludes mass-produced devices manufactured via industrial processes, even if produced according to written prescriptions. These so-called patient-matched devices are produced in batches and do not necessarily require written prescriptions from authorized individuals. A key distinction MDCG makes is that manufacturers are solely accountable for patient-matched devices in terms of design, safety, performance and regulatory compliance.

The importance of written prescriptions for CMDs

Another key issue included in the MDCG Q&A is how written prescriptions for CMDs are defined by the MDR. At the very least, a qualifying prescription should include a specific patient’s name as well as specific design characteristics from an authorized prescriber that correspond to the patient’s features and disease or condition.

Additional items for CMD written prescriptions may include physical or 3D model data, dental or orthotic molds, or dental impressions.

MDR compliance requirements specific to CMD manufacturers

CMD manufacturers should also be aware that they will have to meet specific conformity assessment requirements explained in Annex XIII of the MDR. These requirements include an Annex XIII Statement in lieu of a standard declaration of conformity, which must be made available to the particular patient or user for which a CMD is intended.

Furthermore, conformity assessment procedures for quality management system (QMS) certification from Notified Bodies is also required for Class III high-risk active implantable CMDs, according to the MDCG FAQ. QMS certificates for these devices will have to be entered in the Eudamed medical device database, as well.

On the other hand, CMD manufacturers are not obligated to meet Unique Device Identification (UDI) requirements; while these companies are required to appoint Persons Responsible for Regulatory Compliance (PRRC), those individuals also do not need to be registered in Eudamed.

Finally, although CMD manufacturers are not required to provide Summaries of Safety and Clinical Performance (SSCP), they must establish either Periodic Safety Update Reports (PSUR) for Class IIa, IIb abd III devices or reports for Class I devices in accordance to MDR Article 85.

CMD manufacturers should refer to the full MDCG FAQ document for further information and recommendations regarding MDR compliance.

Learn more about European MDR compliance and CE Marking at Emergo by UL:

• European Authorized Representative in-country representation
• Whitepaper: Extended MDR date of application—optimizing your PMS and clinical activities
• Webinar: Europe’s new Medical Devices Regulation (MDR)