From one Medical Device Manufacturer to another, from one Notified Body to a Medical Device Manufacturer or from one Competent Authority to a Medical Device manufacturer, from Standards to Standards or Regulations, the word “Performance” can be used in a wide different way.
Depending on one’s background, the answer is always different. Some will say it refers back to the Clinical Performance of a Medical Device while for others, it means both Clinical and Technical performances.
In this newsletter, we want to discuss the different usage of the word “Performance’; the possible confusions between Performances and Characteristics and highlight the common pitfalls when using the word Performance within the European regulatory framework.
Definitions and Regulatory Perspectives
There are several definitions to the word Performance in European Regulations and Standards. First, the word Performance is often linked to an adjective. Below, three definitions of this word currently used in European Regulations:
‘Clinical data’ means the safety and/or performance information that is generated from the use of a device. - ISO 14155:2011: 3.9 clinical Performances: behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)
- ‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer;
- ‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;
- ‘performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose;
- ‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;
- ‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;
Although the Medical Device Directive doesn’t include a direct definition to the word, it does associate Performance with Clinical Data. The new European Regulations is more specific and provide definitions for both “Performance” and “Clinical Performance”; and the terms “Analytical Performances” was introduced with the IVDR.
In all of these regulatory definitions, we can identify a strong Clinical component with a recent precision to other “type of performances”. However, when looking a little bit further to device related standards, we can see that the word Performance is either associated to Clinical and/or Pre-clinical data.
Performances: Clinical or Pre-clinical?
While regulatory definitions are generally pretty straightforward, many standards incorporate both Clinical and Pre-clinical data in the requirements for Performance demonstration. The following examples which apply to the Cardiovascular and Orthopedic fields show that performances are often associated to both Pre-clinical and Clinical; but there can be a great variability from one medical field to another:
ISO 5840-1:2015(E) Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
“6.2.2 Performance specifications
The manufacturer shall establish (define, document, and implement) the clinical performance requirements of the device and the corresponding device performance specifications for the intended use and device claims. The specific performance specifications are provided in ISO 5840-2 and ISO 5840-3.”
- In the ISO 5840-1:2015(E) standard, Performance Specifications refer to both Clinical Performances and Pre-clinical Specifications
ISO 21534:2007 Non-active surgical implants — Joint replacement implants — Particular requirements
“4 - Intended performance
For the purpose of this International Standard, the intended performance of implants shall conform to Clause 4 of ISO 14630:—, and the design input shall additionally address the following matters:
- intended minimum and maximum relative angular movement between the skeletal parts to which the joint replacement implant is attached;
- expected maximum load actions (forces and moments) to be transmitted to the bony parts to which the joint replacement implant is attached;
- dynamic response of the body to the shape/stiffness of the implants;
- expected wear of articulating surfaces;
- suitability of the dimensions and shape of the implant for the population for which it is intended;
- strength of the adhesion and durability of surface coatings or surface treatments.”
- In the ISO 21534:2007 standard, Intended Performance refer to both Clinical Performances (a to e) and Pre-clinical Specifications (f)
ISO 14630:2012 Non-active surgical implants - General requirements
“4 Intended performance
The intended performance of an implant shall be described and documented by addressing the following, with particular regard to safety:
- intended purpose(s);
- functional characteristics;
- intended conditions of use;
- intended lifetime.
NOTE To describe the intended performance, it is advisable that particular account be taken of the following, among
— published standards,
— published clinical and scientific literature, and
— validated test results.”
- In the ISO 14630:2012 standard, Intended Performance refer to both Clinical Performances (a, c, d) and Pre-clinical Specifications (b)
So with such a wide usage of the word Performance, it becomes critical to specify and associate the right data to the right type of Performances when describing a medical device in the Technical Documentation or when answering to the Directive Essential requirements or the MDR General Safety and Performance requirements.
Pitfalls in using the word “Performance”
When a Medical Device Manufacturer uses the word “Performances”, without associating it with an adjective to describe both Clinical Performances and Devices Specifications, this often leads to confusion in the Clinical Performance description required by the Regulation (in the Clinical evaluation, Instruction for use, etc.).
If ones’ intent is to use the word Performance to refer to both Pre-clinical and Clinical data; it is crucial that these performances are correctly named and properly defined from the beginning (Clinical Performances, Functional performances etc.) so that all parties involved have the right understanding.
We often see that if the manufacturer introduces a clear definition of performances (i.e Clinical Performance) and characteristics (i.e specifications, functional specifications…), describing what both words stand for; then it’s usually followed by their adequate descriptions in the Medical Device Technical Documentation.
Confusion between Clinical Performance and Medical Device Characteristics
Once properly defined, the challenge often lies with how to properly “classify” Performance and what are the Medical Device Characteristics/Specifications of a given product. The key is to remember that performances as requested to be described, for example by the MDD, in the Instructions For Use, are Clinical Performances. The mean to reach these performances are characteristics (In-situ degradation of the material, Maintenance of mechanical properties); the impact/result on the patient is Performance (Functional recovery, Restoration of the joint function, Pain relief…)
With the ongoing changes and more coming up, even if not all of the references are harmonized for the terminology used, it is critical that all stakeholders use a clear definition of Performances. The new European Medical Device Regulations have added definitions, but not the current Directives. Variety will always exist but a common understanding of what Clinical Performance includes is critical to properly answer to the Regulatory Requirements.
Keep in mind that the Medical Device Clinical Performances are the Clinical results claimed by the Medical Device Manufacturer.