FDA QMSR and Medical Device File

 

 

 

 

 

 

 

 

 

 

 

 

FDA QMSR and Medical Device File

On January 31, 2024, FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many regulatory authorities worldwide – ISO 13485:2016. You can see the final rule here. The focus of this post is to understand a newly introduced term in the FDA Quality Management System Regulation (QMSR) – Medical Device File (MDF) and Medical Device Family.

As per ISO 13485 (4.2.3), medical device manufacturers will now need to contain or reference the procedures and specifications for the entire life cycle of the manufactured product – in the Medical Device File. The final design output from the design phase, which was previously maintained or referenced in the design and development file, will now form the basis of the MDF.

FDA Medical Device File – Content

According to ISO 13485 4.2.3, the MDF shall include, but is not limited to:

a) general description of the medical device, intended use/purpose, and labeling, including IFU;
b) product specifications;
c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;
d) procedures for measuring and monitoring;
e) requirements for installation and/or procedures for servicing, if appropriate

The MDF should be generated for each medical device type or medical device family.

FDA Medical Device Family – Definition

New QMSR doesn’t provide a Medical Device Family definition and therefore we need to look for other sources. The first and most important place to look for QMSR definitions is ISO 13485:2016.

ISO 13485 (3.12) defines Medical Device Family – as 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.

We found an old but useful definition for MDF in the FDA guidance from 2015: GN-12-1: Guidance on Grouping of Medical Devices for Product Registration – General Grouping Criteria

According to this document, a medical device family is a collection of medical devices, and each medical device family member:

• is from the same product owner;
• is of the same risk classification;
• has a common intended purpose;
• has the same design and manufacturing process; and
• has variations that are within the scope of the permissible variants.

A characteristic of a medical device may be considered a permissible variant if:

• the physical design and construction of the medical devices are the same, or very similar;
• the manufacturing processes for the medical devices are the same, or very similar;
• the intended purpose of the medical devices is the same; and
• the risk profile of the medical devices, considering the above factors, is the same.

Basic UDI-DI and MDF

The manufacturers which market their products in the EU under Medical Device Regulations (MDR) may consider products that fall under the same Basic UDI-DI as candidates for the single MDF. Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation, and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.

Generic Device Group and MDF

The manufacturers may also consider the products included in a Generic Device Group (MDR Article 2(7)) although it seems that this definition is broader than the MDF definition in the ISO 13485. The Generic Device Group is defined as a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics

Another useful definition of Medical Device Family is found in the Health Canada document – Guidance for the Interpretation of Sections 28 to 31: License Application Type: A Medical Device Family is composed of devices that are made by the same manufacturer and that differ only in style, color, flavor and/or size and have the same design, manufacturing process and intended use.

Timelines for QMSR  Implementation

Medical device manufacturers who already market their products in the U.S. or intend to do so will have two years to upgrade their quality system to include ISO 13485:2016 requirements. FDA will begin to enforce the QMSR requirements at the beginning of February 2026. Our advice is – start now!

BioReg Services

Don’t hesitate to contact us for any assistance on Medical Device File and how to properly group the products in your portfolio. In addition, our team provides cost-effective help with all ISO 13485 Transition, CE EU-MDR Certification or other Quality & Regulatory Consulting tasks.

BioRegards,

Daniel