Dear h/p/cosmos distributor and service partner,
Safety for patients, athletes, therapists and operators and service technicians has always been a priority for everyone at h/p/cosmos. From the quality of raw materials and the manufacturing steps to the correct and complete certification of the products, especially for medical devices, safety is deeply embedded in our DNA.
Over the past decades, we have made enormous efforts to comply with the applicable regulations for medical device manufacturers to the best of our knowledge and belief. Contrary to our understanding as a responsible manufacturer, there is a wide variance of unintentional or in rare cases even deliberate violations of applicable law.
In order to provide you with an overview of this complex field and ensure that you can act with confidence, h/p/cosmos is hosting a free webinar with the support of a law firm specialising in medical device law. Take advantage of our commitment and long-term expertise and the law firm Dr. Lücker and play it safe. Register here for the free webinar.
An incorrectly classified medical device or a machine without a correct EU declaration of conformity can pose enormous risks for all parties involved. It is also important to note whether a CE mark is sufficient or whether a CE mark requires a 4-digit identification number from a notified body for certification, e.g. CE0123.
Motor-driven treadmills with medical claims are not only medical devices but also machines that require CE marking and a declaration of conformity for machines, as they are powered by an external energy source (electricity) and have moving parts such as shafts, running belts and, in most cases, lifting elements for simulating incline angles. See Machinery Directive 2006/42/EC Article 2.
As an active medical device (therapeutic use, e.g. physiotherapy and/or diagnostic use, e.g. for ECG stress tests device), a motor-driven treadmill is classified in risk class IIa or IIb according to MDR Rule 9 (or sub-rule 10) because walking and/or running on the running belt results in an exchange of energy (mechanical kinetic energy) between the medical device and the patient.
The MDR stipulates that incorrect classification of a medical device means that the product is not marketable and therefore may not be distributed or placed on the European market.
As a result, the Federal Institute for Drugs and Medical Devices (BfArM in Germany) confirmed the applicability of Rule 9 for a motorized treadmill for physiotherapy and/or diagnostic use in a classification decision dated February 28, 2025, based on Section 6, Paragraph 2 of the German Medical Devices Law Implementation Act (MPDG).
MDR Article 2 Definitions:
(12) ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;
[...]
The BfArM does not examine product groups, but always examines each product on a case-by-case basis, taking into account the respective intended purpose and other performance data. The applicability of Rule 9 (for the medical treadmill for physiotherapy and diagnostic use) and the fact that mechanical kinetic energy is transferred/exchanged on the treadmill has now also been confirmed by the BfArM, among others.
Ergo, h/p/cosmos assumes that Rule 9 applies to all motorised treadmills with intended use for physiotherapy and rehabilitation, because the basic laws of physics and biomechanical principles of walking and running on a treadmill are identical regardless of the manufacturer and model.
Motorized treadmill as active therapeutic and/or active diagnostic device = Class IIa or IIb.
The responsible trade supervisory offices in market surveillance (“Gewerbeaufsichtsamt Marktueberwachung”) also follow this classification as class IIa or IIb with statement dated April 8, 2011, and ongoing communications.
Also the specialized Law Office for Medical Device Law Dr. Volker Lücker (Attorney at Law) and Claudia Schenkewitz (Attorney at Law) from Essen / Germany confirmed in a statement dated 19.12.2025, that MDR classification rule 9 is applicable for motorized treadmills for physiotherapy and rehabilitation use.
And consecutively, the TÜV Sued in Münich has confirmed with certificate G100452830027 rev. 00 dated 2022-11-18 that the manufacturer h/p/cosmos has implemented a Quality Management Systems for class IIa and IIb devices (medical treadmills) based on MDR.
To provide further understanding and clarification on this important topic, responsibilities and risks, a published expert letter from Dr Lücker dated 19 December 2025 is available for your download and a free webinar will be held 29 January 2026 at 16:00 PM German time.
A good summary can be drawn from the linked expert letter from h/p/cosmos dated 11 October 2025, including a download of expert opinions from well recognised professors of biomechanics.
h/p/cosmos also trained all distributors on this topic at its international distributor meeting from 6 to 9 April 2025 in Hohenkammer near Munich and has started intensive campaigns also contacting German and European Authorities if wrong risk classifications as medical devices or missing DoC for machinery for treadmills have been identified.
The manufacturer of medically used treadmills must be certified by a notified body (e.g. TÜV) at considerable expense and effort. The CE mark on the treadmill requires a 4-digit identification number! If a treadmill is classified as a medical device in risk class I and does not have a 4-digit identification number behind the CE mark, an incorrect classification rule has been applied and it is not compliant with EU regulations.
The North Rhine-Westphalia State Office for Health and Occupational Safety states the following regarding machines that do not comply with EU regulations:
[…] If the supervisory authority determines that a machine is being operated without the required declaration of conformity and CE marking, the employer may face a shutdown order until the machine is brought into compliance with the law. If an accident occurs on such a machine, criminal investigations may be conducted against both the distributor and the employer. […] Source: https://www.komnet.nrw.de/_sitetools/dialog/5364
Many people think that a CE mark on a product is sufficient and rely ‘blindly’ on such a CE mark. However, not all products with a CE mark comply with European requirements, partly due to ignorance or perhaps partly due to the intention of some manufacturers to save on certain expenses and controls, and thus high costs and time until the launch of a new product, by using an incorrect and too low risk classification.
For this reason, not only manufacturers but also economic operators such as importers, EU authorised representatives, distributors and dealers have special responsibilities to ensure compliance with the relevant regulatory requirements, which are laid down in EU regulations such as the Medical Devices Regulation (MDR) (EU) 2017/745 and the Machinery Regulation (EU) 2023/1230 (which also applies to sports treadmills without a medical purpose).
Operators of medical devices such as clinics, doctors' surgeries and rehabilitation centres also have important legal requirements to comply with. The Medical Devices Operator Ordinance (MPBetreibV) in Germany regulates the obligations of operators when handling medical devices, from procurement to operation and maintenance.
An important revision since February 2025 incorporates that also software and IT security addresses more strongly and introduces new terms such as ‘provider’ to create clear responsibilities in clinics, practices and care facilities and to increase patient safety. It stipulates that products must be used for their intended purpose, operated competently and in accordance with the state of the art, and requires, among other things, an inventory and a medical device safety officer for companies with 20 or more employees.
This German regulation for sure will differ from regulations for operators in other countries, but intentions of lawmakers are the same:
“Operators have to purchase, use and maintain safe devices in compliance with local regulations.”
Since its foundation in 1988, h/p/cosmos has been extremely committed to the safety of medical devices and sports equipment. Since the MDD / MPG came into force in June 1998, h/p/cosmos has correctly classified its treadmills in risk class IIb and as machines.
With awareness campaigns on compliance with the applicable regulations, h/p/cosmos is committed to the safety of operators, users (patients, athletes and also service technicians) and all economic actors involved.
h/p/cosmos has already undertaken a large number of training courses, seminars and publications on the subject of medical devices and machines. We are happy to invite you to the upcoming webinar on January 29, 2026 starting 4:00 pm CET.
Follow this link to sign up for the webinar.
Check h/p/cosmos devices and details on the EUDAMED Database: SRN: DE-MF-000006147