Why is my compression stocking a medical device?
According to the definition (MDD/MDR), medical devices are products or substances that are used for medical-therapeutic (also preventive) or diagnostic purposes for humans, whereby the intended main effect, in contrast to drugs, is primarily not pharmacological, metabolic or immunological, but mostly physical or physicochemical.
When products are used for therapeutic purposes on humans, this makes the product a medical device.
Let’s look at this using the example of compression stockings. Colloquially referred to as support stockings, depending on the compression class they are advertised and used, among other things, for thrombosis prophylaxis or for the therapy of lymphatic or venous leg disorders.
The purpose of the design alone already carries the intended use here.
It is worth taking a look at Meddev 2.4.1 Rev9, for example, where 4.2 lists compression stockings as an example of Class I products.
What are the implications of this regulatory classification?
For medical devices, conformity with the Medical Device Directive/Regulation must be assessed and declared, and subsequently a CE mark must be applied to the product. In order to declare conformity, the manufacturer must maintain technical documentation and a QM system to demonstrate compliance with all relevant essential requirements.
Can this effort be avoided? And if so, how?
In some cases, it would be sufficient to remove the claim referring to a medical device from the product and its description. In most cases, however, the intended purpose is determined by the product design itself and is thus inherent in the product. Therefore, the product is then subject to mandatory MP law, the best example of this is the compression stocking!
When may a CE mark be affixed to a product?
As explained at the beginning, the basis for a CE mark is compliance with the legal requirements of Germany and Europe, which can be found in the Medical Device Directive 93/42/EEC and the Medical Device Regulation 2017/745, respectively, and in German legislation, including the Medical Device Act and the Medical Device Implementation Act. Important components here are a quality management system, the evidence to be provided for the essential requirements in the form of technical documentation, and a final declaration of conformity for medical devices confirming compliance with all relevant specifications from the relevant legislation.
How must technical documentation be structured?
The documentation serves as evidence of the performance and safety of the respective product, starting with its development and continuing through its acceptance in the market as well as throughout the entire product life cycle. This evidence must be documented as defined in the MDD/MDR. In particular, the requirements for the MDR, which will apply from May 2021, are clearly defined in Annex II and Annex III.
What are the consequences of a QM system?
A QM system primarily stands for regulated processes and the guarantee that a product designed and manufactured under it always conforms to specifications, achieves the safety and performance proven in the technical documentation, and can thus be placed on the market. To this end, responsibilities are defined, activities and processes are described in detail, and necessary control steps are specified.
Who is involved in the declaration of conformity?
The manufacturer declares conformity with the corresponding legal basis on his own responsibility; for products of a higher risk class than Class I according to MDD/MDR, a Notified Body is involved; however, the manufacturer also acts on his own responsibility here.
What happens if I ignore the legal requirements?
For one thing, German law provides for penal provisions, which are regulated in the Medical Devices Act: Consequences of up to three years’ imprisonment or a fine are described there (§40-43 Medical Devices Act).
However, apart from the legal aspect, the damage to the patient should not be forgotten: Most patients rely on the claims made by the medical device manufacturers or the corresponding products and trust the accuracy and safety of these, especially in the case of German quality products. Thus, inadequate evaluations and examinations of the products ultimately harm not only the individual patient, but also the brand “Made in Germany” and the reputation of an entire industry.
What to do now?
You were not aware until now that your product is subject to the requirements for medical devices? You lack sufficient capacities to provide the evidence in a timely manner? Would you like to advertise your product as a medical device and place it on the market in the future? Then get in touch with us. We will gladly accompany you on your way through a correct conformity assessment procedure.
Please note that all details and listings do not claim to be complete, are without guarantee and serve purely as information.
Due to the rapidly changing situation in the context of the Covid 19 pandemic, changes in legal or regulatory requirements may occur at short notice, which we are unable to reflect on a daily basis.
