Accessories for Medical Products: Definition and Regulatory Requirements
There are many definitions of "accessory". The term accessories differentiates in its definition in the medical devices act. This article gives you an overview about the definitions and the regulatory requirements and answers frequently asked questions.
Definition of "accessories"
There are several definition of the term "accessory".
Medical Device Directive
The first definition is given by the Medical Device Directive (MDD):
Medical Device Regulation
A comparable definition is provided by the Medical Device Regulation (MDR):
The FDA defines medical devices and medical device accessories not seperately:
- […] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
The Medical Devices Act applies to medical devices and their accessories. "Accessories shall be treated as medical devices," writes the German MPG.
Therefore manufacturers have to prove all essential requirements and undergo a conformity assessment procedure for these accessories.
The MDR did not change this approach of applying the same rules for medical devices and accessories:
"This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union." (MDR, Article 1)
The FDA sees this similarly: „The FDA has a long-standing rule which says that anything intended to be used as an accessory to a medical device is itself a medical device and regulated to the same level as the device it accessories.“ [Source]
Can software be an accessory to a medical device?
Is an independent (stand-alone) software for calibrating a medical device itself a medical device? Or an accessory to a medical device? Or neither? If the software is explicitly designed to calibrate a medical device or medical devices but not meant to treat or diagnose patients itself, then this software is a medical device.
Special case "Germany"
Deviating from today's definition the MPG defined accessories in the first 1994 edition, as follows:
"Accessories for medical devices are items, substances and preparations of substances that are not medical devices such as the ones referred to in point 1, but are intended by the manufacturer to be to, [...] "
With the amendment of the MDD in 2007, the definition of a medical device has been expanded to make it clear that even software can be a medical device. This can be found in the justification for the amendment. The implementation into MPG in 2009, adopted this definition in the wording and fit in the same change in the definition of accessories too by deleting "Software". But this should not mean that software can no longer be a accessory.
Conclusion: The problem occurs because of the acquisition of the definition of accessories to the MPG and is a misinterpretation of the amendments of 2009.