The importance of the Medical Device Regulation for training equipment in rehabilitation, physiotherapy and the fitness
Nowhere else will you find a better overview of the selection of medical equipment that is available for therapy, diagnostics and training in the fields of rehabilitation and prevention than at FIBO, where countless exhibitors from around the world come to present their training equipment. Yet what is it that distinguishes medical training equipment from the training equipment we are familiar with from fitness studios?
How does medical training equipment differ from conventional training equipment?
The biggest difference lies in the intended use for the equipment. In its Council Directive 93/42/EEC from 14 June 1993, the EU regulates the proper use of medical devices. These guidelines are known internationally as the Medical Device Directive (MDD).
In May 2017, a new EU regulation came into force for medical devices. This is known as the Medical Device Regulation (MDR), and it is valid and applicable without separate implementation in national legislation. Following a three-year transition period, it is set to supersede the Medical Device Directive 93/42/EEC (MDD).
The new MDR is meant to ensure that any devices used to examine, treat or monitor patients satisfy particular standards. As a result, implants, x-ray machines, pacemakers and training equipment are all considered to be medical devices, and are subject to European guidelines and the regulations resulting therefrom.
Among other things, the MDR mandates that medical devices, and therefore corresponding training equipment, cannot endanger either the safety or the health of patients and users. For example, the CE marking is a fundamental requirement for medical devices, and it verifies that European legislation and regulations have been complied with.
How does medical training equipment receive regulatory approval?
It is often assumed that the manufacturers submit their training equipment for certification or testing, much as is done for vehicles. However, this is not the case for medical devices. Manufacturers are themselves responsible for conducting EU conformity assessments.
In order to do this, the manufacturer must have a comprehensive quality management system in place. This QM system is then audited by a so-called “notified body”, i.e. an independent testing organisation, and certified. This means that the inspection is not performed directly on the device, but rather on the quality management system that has been put in place at the manufacturer.
Among the requirements that such QM systems must satisfy are the provision of detailed technical documentation, including risk management files, and clinical evaluations. This clinical evaluation is ether conducted by the manufacturer themselves or, for devices classified in risk class IIa or higher, by a “notified body” that has been accredited by a national organisation/authority. Here, the manufacturer must demonstrate that the medical device offers sufficient medical efficacy. Furthermore, the manufacturer must ensure that their medical devices do not result in any unexpected or unacceptable side effects.
Another requirement is that the manufacturer classify the device by assigning it to one of four risk groups. Medical devices are assigned to risk classes I, IIa, IIb and III, whereby class III poses the greatest potential risk, and is therefore subject to the most intensive compliance procedure. Medical training equipment is generally assigned to class I or class IIa, whereby equipment classified as IIa is distinguished by the fact that it has an external power source.
Other requirements and obligations for the manufacturer
The requirements that the MDR places on manufacturers go far beyond those mandating the appropriate QM system and a clinical study. For instance, the manufacturer's sales staff/consultants must be trained as qualified medical device consultants, and are subject to ongoing training requirements. The manufacturer's equipment must satisfy demanding safety requirements, including for its operability and biomechanics. When transferring the training equipment to the healthcare facility, the manufacturer is obligated to provide an introduction to this equipment during which the medical device book is also transferred.
As a result of these and other obligations, medical training equipment is more expensive than conventional fitness equipment. Even so, there is no choice – anyone who examines, treats or monitors patients is obligated to use appropriate medical devices for these purposes.
What is the importance of the Medical Device Regulation (MDR) for the fitness industry?
The regulations contained in the MDR are only relevant for fitness studios when services are invoiced either directly or individually through health insurers within the framework of supported programmes. These regulations are also applicable when patients are receiving treatment on the premises as a result of a special programme. It is important that national legislation and regulations are always taken into account here as well.
What things does the operator of a healthcare facility have to take into account?
The operator is the party that owns the medical device and that is responsible for making decisions regarding this item. Responsibility is transferred from the manufacturer to this party at the time the device is transferred to them and the item is commissioned.
Operators are obligated to ensure that the provisions of the MDR are complied with, and thus that risks are minimised. This includes ensuring that the devices are properly maintained and functional.
The operator of a medical device is obligated to instruct their employees before the medical device is put to use. The fact that instruction has taken place must be documented in the medical device book. The operator must also document all measures undertaken for the care and maintenance of the device and all safety checks in the medical device book. The manufacturer gives the medical device book to the operator when the relevant piece of equipment is delivered. The operator can also assure themselves that the manufacturer has supplied them with a device that complies with the Medical Device Regulation by checking the CE marking and reviewing the declaration of conformity.
When using active medical devices, i.e. medical devices from risk class IIa that are operated using an external power supply, the operator must conduct safety checks as part of their maintenance. The objective of such safety checks is to identify any defects as early as possible and to eliminate these, in order to reduce device downtime, for example. The operator is responsible for setting their own deadlines for safety checks, as they are the only party that is able to properly assess the wear and level of use to which a device is being subjected. However, at least one safety check must be conducted and documented in the medical device book every two years.
Healthcare facilities that regularly have more than 20 members of staff are obligated to designate one person with responsibility for the safety of medical devices. This is the facility’s centre for all tasks and obligations arising from the provisions of the MDR. A function-specific email address must be set up for this person and announced on the website.
Prohibitions and reporting obligations under the MDR
Under the terms of the MDR, any medical devices whose proper operation endangers the health or safety of patients, users or any other individuals involved are fundamentally prohibited.
If a medical device is found to have a fault or defect, it can no longer be used. If the error in question is a mistake in the operating instructions for a medical device or in the device itself, it is generally necessary to notify the appropriate national institute for medical devices and the manufacturer without delay.
The reporting obligation also applies if, during operation or use of a medical device, there should be a malfunction, irregularity or change in performance that results, or could have resulted, in the death or severe deterioration in the health of a patient, employee or third party.