What exactly is a medical device family?

Or device group?

Or medical device family group?

What criteria does your company use to assign individual devices to a family?

Who is responsible for maintaining the structure of your device families?


Harper Lee quote from To Kill a Mockingbird

You can choose your friends but you sho’ can’t choose your family…”

Human families come in all shapes, sizes, colours, genders and ages. However; in the case of medical device categorisation, the definition of a “family” of product codes is entirely up to you.

So which definition do you use?

ISO 13485:2016

https://www.iso.org/obp/ui#iso:std:iso:13485:ed-3:v1:en

​Medical Device Family is a group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function.

Health Canada​

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html

Medical Device Family

A group of medical devices that are made by the same manufacturer, that differ only in shape, colour, flavour or size, that have the same design and manufacturing process and that have the same intended use.

Medical Device Group Family

A collection of medical device groups that are made by the same manufacturer, that have the same generic name specifying their intended use, and that differ only in the number and combination of products that comprise each group.

Health Sciences Authority (HSA) Singapore

https://www.hsa.gov.sg/medical-devices/registration/grouping/family

Family grouping requirements

Medical devices under a family have to meet all of the following requirements:

  • From the same product owner
  • Have the same risk classification
  • Have a common intended purpose
  • Have a common design and manufacturing process
  • Have variants that are within the scope of permissible variants

Therapeutic Goods Administration (TGA) Australia

https://www.tga.gov.au/kind-medical-device

Devices are taken to be of the same kind if they have the following characteristics:

  • the same sponsor
  • the same manufacturer
  • the same classification
  • the same Global Medical Device Nomenclature System Code (GMDN code)
  • for Class III, Class AIMD medical devices and Class 4 IVD medical devices (other than an immunohaematology reagent that is a Class 4 IVD medical device) the same unique product identifier (UPI)

Replacement Reagent and Instrument Family Policy (US FDA Guidance)

https://www.fda.gov/media/111186/download

An instrument family consists of similar analysers made by one manufacturer that yield the same analytic result from samples of the same specimen within stated tolerance limits. A device family refers to a group of two or more devices manufactured by or for the same manufacturer and having the same:

  • Basic design and performance characteristics related to device safety and effectiveness that share a common Design History File (DHF) (See 21 CFR 820.30(j)),
  • Intended use and function, and
  • Device classification and product code.

Common Data Elements for Medical Device Identification (IMDRF)

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-rps-common-data-elements.pdf

Model

The value used to represent one medical device or a family of medical devices to group many variations that have shared characteristics.

Unique Device Identification system (UDI system) Application Guide (IMDRF)           

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190321-udi-sag.pdf

Regulatory Authorities should be aware that this guidance does not specifically cover certain emerging issues with UDI systems, such as: tools and device categorization nomenclature for grouping similar devices

Applied for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/45 (MDR) Notified Bodies Operations Group (NBOG)

https://www.nbog.eu/nbog-documents/

This NBOG’s best practice guide applicable for MDR provides a list of codes that reflect the design and intended purpose of the devices for which the NB would apply for designation scope and the manufacturer would request for conformity assessment.

Example

Organisational Business Unit/Marketing Defined

All medical devices managed and marketed under a broad business directed umbrella ie. Paediatric Orthopaedics, Wound Dressings, or US Dental without a requirement for same intended use, class or DHF.


If you are struggling to respond to any of the questions regarding family designations for your medical device portfolios, then you have an immediate need to initiate a programme in order to prepare a consistent approach for your supervening global identification data reporting requirements. Choosing inconsistent family categorisations will have a negative impact on your device identification data output efficiencies, such as UDI compliance and regional registration groupings.

A structured global identification scheme requires a positive investment in a data management strategy that centres on the accurate and consistent collection of the substantial volume of medical device identification data.

Choose your families wisely.

For more information on increasing data management efficiencies please feel free to contact me at Kimyoung@intem.com

K Young