YOUR SELEON SPECIALIST

Anne Matousek
Senior Consultant QM & RA, Regulatory Affairs Expert

Tel.: 07131 2774-40
regulatoryaffairs(at)seleon.de

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08.07.2020

Your stocking is not just a stocking – it might also be a medical device!

In this case there are a few things to consider. Not only for the users, but especially for the manufacturers if the textiles are used as part of thrombosis prophylaxis, following surgical procedures such as varicose vein removal, or in other cases.

kompressionsstruempfe-medizinprodukt
kompressionsstruempfe-medizinprodukt
kompressionsstruempfe-medizinprodukt
kompressionsstruempfe-medizinprodukt

Why is my compression stocking a medical device?

According to the definition (MDD/MDR), medical devices are products or substances used for therapeutic (including preventive) or diagnostic purposes for human beings, whereby the intended principal effect, unlike that of medicinal products, is not primarily pharmacological, metabolic or immunological, but usually physical or physicochemical.

When products are used for therapeutic purposes on humans, they become medical devices in doing so.

Let's look at the example of compression stockings: colloquially known as support stockings, they are advertised and used, among other things, for thrombosis prophylaxis or for the therapy of lymphatic or venous leg disorders, depending on the compression class.

The function of the design alone contains the intended use within itself.

It is worth taking a look at Meddev 2.4.1 Rev9, for example, where in 4.2 compression stockings are given 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 consequently a CE mark must be applied to the product. In order to be able to declare conformity, the manufacturer must maintain a technical documentation and a QM system in order to be able to prove that all applicable essential requirements are met.

 

Can I avoid all this effort? 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 use is determined by the product design itself and is thus inherent in the product. As a result the product is mandatorily subject to the medical device law, the best example for this is the compression stocking!

 

When may a CE mark be applied to a product?

As already explained at the beginning, the basis for CE marking is conformity with the legal provisions of Germany and Europe, which are to be found in the Medical Device Directive 93/42/EEC (MDD) or the Medical Device Regulation 2017/745 (MDR) and in German legislation, including the German Medical Device Act and the German Medical Device Implementation Act.

Important components here are a quality management system, the evidence to be provided for the basic requirements in the form of technical documentation and a final declaration of conformity for medical devices, which confirms compliance with all relevant requirements from the relevant legislation.

 

How do I have to build up a technical documentation?

The documentation serves as proof of the performance and safety of the respective product, starting with the development, continuing with the acceptance in the market and continuing throughout the entire product life cycle. These proofs must be documented as defined in the MDD/MDR. In particular in the MDR, which will apply from May 2021, the requirements are clearly defined in Annex II and Annex III.

 

What does a QM system mean for me?

A QM system primarily stands for controlled processes - to bring a product to market that always conforms to specifications and always achieves the safety and performance proven in the technical documentation. To this end, responsibilities are defined, activities and processes are precisely described and necessary control steps are specified.

 

Who is involved in the declaration of conformity?

The manufacturer declares conformity with the corresponding legal requirements under his own responsibility. For products with a risk class higher than Class I according to MDD/MDR, a Notified Body is involved, but the manufacturer also acts under his own responsibility.

 

What happens if I ignore the legal requirements?

On the one hand, German law provides for penal provisions; these are regulated in the Medical Devices Act: There consequences of up to 3 years imprisonment or a fine are described (§40 - 43 German Medical Devices Act)

Apart from the legal aspect, however, the damage to the patient should not be forgotten. Most patients rely on the claims of the medical device manufacturers or the corresponding products and trust in the correctness and safety of the same, especially with German quality products. Thus, a lack of evaluation and testing of the products ultimately damages not only the individual patient, but also the brand "Made in Germany" and the reputation of an entire industry sector.

 

What is to be done now?

You were not aware that your product is subject to the requirements for medical devices? You do not have sufficient capacity to provide the proof in a timely manner? You would like to advertise your product as a medical device and market it in the future? Then get in touch with us. We will be happy to guide you through the correct conformity assessment procedure.

 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.

Every product is unique – the mandatory tasks and measures for entering the market need to be specified individually. seleon advises you on your individual questions without any obligation.

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04.08.2020

... at least when they are really used in case of illness or recovery. In order for users to have confidence in the effect, the manufacturers must observe the strict requirements of the MDR. Otherwise, these medical textiles cannot be labelled and used as such.

Regulatory Affairs
08.07.2020

In this case there are a few things to consider. Not only for the users, but especially for the manufacturers if the textiles are used as part of thrombosis prophylaxis, following surgical procedures such as varicose vein removal, or in other cases.

Regulatory Affairs
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Medical device manufacturers have more time! EU extends transition period until May 2021 Read more about the basics and dates in the article.

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