{"id":33633,"date":"2019-12-02T22:05:00","date_gmt":"2019-12-02T20:05:00","guid":{"rendered":"https:\/\/ostro.si\/?p=33633"},"modified":"2026-06-02T11:25:39","modified_gmt":"2026-06-02T11:25:39","slug":"compression-socks-in-false-disguise-sneak-into-stores","status":"publish","type":"post","link":"https:\/\/ostro.si\/en\/stories\/operacija-vsadki\/compression-socks-in-false-disguise-sneak-into-stores\/","title":{"rendered":"Compression Socks in False Disguise Sneak into Stores"},"content":{"rendered":"\n
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For over two years, the packaging of Silverline knee-high compression socks manufactured by Vita Vera, d. o. o., bore the CE marking, i.e. a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations. Before selling a product, a manufacturer first has to prove its conformity with these regulations and only then the CE marking can be attached to it.<\/p>\n

The Silverline knee-highs were on sale since 2016 despite not fulfilling these requirements until November 2018, as is clear from the documents acquired by O\u0161tro.si. This was when the manufacturer submitted an application to be entered into the national register of manufacturers of medical devices, whereupon the socks could then also be entered into the register of medical devices. Both registers fall within the competence of the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). <\/p>\n

According to law, a manufacturer must carry out the notification within 15 days from placing the medical device on the market. If the CE marking is unduly affixed to a medical device that does not comply with the law<\/a> or is against it, the manufacturer could face a fine of EUR15,000 to EUR150,000, whereas the person responsible could be fined from EUR300 to EUR3,000. <\/p>\n

JAZMP\u2019s inspection is ongoing<\/strong><\/h3>\n

In line with the European regulations, compression socks are classified as a Class I medical device that is non-invasive and poses a low risk to the user. They are available without a prescription. <\/p>\n

In order for such a device to be entered into the JAZMP\u2019s register, a declaration of conformity must be provided in which a manufacturer undertakes to keep the technical documentation which demonstrates that the device complies with the requirements of Directive 93\/42\/EEC. The competent authority, i.e. JAZMP, can obtain access to his documentation only for purposes of an inspection procedure. <\/p>\n

JAZMP already commenced the inspection regarding the Silverline compression socks manufactured by Vita Vera. As it is not yet finished, the agency is not disclosing any information. Thus, it was not possible to independently verify when the technical file was prepared. It should be noted that a manufacturer can also assign an earlier than an actual date to the file which the competent authority is unlikely to discover before beginning an inspection procedure. <\/p>\n

A part of Vita Vera\u2019s electronic correspondence that is kept at O\u0161tro\u2019s editorial office shows that the company tried to agree on consultancy as regarded drawing up the technical documentation as early as in spring 2018, while it simultaneously discussed commission sale of Silverline knee-highs with the wholesaler Salus. According to information from our source, the actual preparatory work and the making of the technical file did not begin until November 2018. <\/p>\n

Mitja Perko, Director of Vita Vera, assured O\u0161tro.si in his exhaustive replies that the technical documentation was already put together in the first half of 2017. And that, in 2018, they amended it to comply with the new European directive that enters into force in May 2020. <\/p>\n

He also wrote that he wishes to clarify the actual state of affairs by sharing findings of the inspection procedure. He asserted that the agency established that Vita Vera can continue selling its socks uninterruptedly because allegedly no irregularities were found and it was clear from the initial technical documentation that socks \u201ccomply with the standard for compression hosiery\u201d. <\/p>\n

We explained that the inspection procedure is ongoing and that his statement could not be true, to which he replied that he stated interim findings and that the agency imposed on Vita Vera \u201ca deadline to end some other minor infringements and that until this deadline expires, JAZMP cannot issue the final decision on everything it inspected\u201d.<\/p>\n<\/div>\n\n

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Rems Odar from SIQ sent an unambiguously clear message to Vita Vera\u2019s representative in February 2017: Compression socks are a Class I medical device.<\/p>

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We presented Perko\u2019s replies to JAZMP and asked them to comment. They reiterated that the inspection is ongoing. As they have not yet issued a decision, the disclosure of information before the procedure is completed could threaten its implementation. Until then, they can still acquire new information, facts and evidence. <\/p>\n

They added, however, that the legal entity which is the subject of the procedure \u201chas the right to disclose any information it might have to the public\u201d.<\/p>\n

Consultation<\/strong><\/h3>\n

Among Vita Vera\u2019s documents that O\u0161tro.si obtained is also a consultancy offer by Timian, Marjetka Kralj Kun\u010di\u010d, s. p., for \u201cpreparing the technical documentation for medical devices from the group Compression socks\u201d dated 6 April 2018. According to Kralj Kun\u010di\u010d\u2019s assurances to O\u0161tro.si, the offer was never carried out.<\/p>\n

As she explained, after submitting the offer, she did not hear from Vita Vera for a while and then the company again contacted her in November. She said that, this second time, she did not provide consultancy services for preparing the technical documentation but did not reveal what kind of services she did offer. Vita Vera\u2019s representative told her that the socks with the CE marking are already being sold on the market. <\/p>\n

Kralj Kun\u010di\u010d is also an auditor and advisor for medical devices at the Slovenian Institute of Quality and Metrology (SIQ), as stated on the organisation\u2019s website. SIQ is the national notified body in the field of medical devices. It is only responsible for determining the compliance of devices that belong to higher classes and entail a higher risk, which excludes compression socks. <\/p>\n

In February 2017, Vita Vera\u2019s representative contacted SIQ. He discussed compression socks with Vesna Rems Odar from the department for certification of medical devices. In an e-mail, she summarized their meeting with: \u201cCompression socks are a Class I medical device.\u201d <\/p>\n

This means that Vita Vera\u2019s representatives have been aware of the information provided by professionals, namely that compression socks are definitely classified as medical devices, also according to European regulations.<\/p>\n

We asked SIQ if Vita Vera\u2019s representative told them that their socks are already affixed with the CE marking and are being sold on the market but we still waiting for their reply. We will publish it once we receive it. <\/p>\n

Sale with a touch of miracle<\/strong><\/h3>\n

The Silverline socks have been on sale since 2016, first on-line and later in pharmacies. In January 2018, as can be gathered from Vita Vera\u2019s website archives, the company also started to sell the Silverline classic socks. The socks that are today officially entered into the register of medical devices are called Silverline classic. <\/p>\n

Before the socks were entered into the register, the manufacturer promoted their sale with various slogans referring to tired and swollen legs or varicose veins, as well as claims about specific health effects.<\/p>\n

In November 2016, the month of diabetes, the company informed its Facebook fans that this disease also affects the legs: \u201cSilverline\u2019s micro-circulation system promotes healthy limbs.\u201d<\/p>\n

In February 2017, it made promises that \u201cwith the help of Slovenian innovation, we can relieve the symptoms of venous weakness and tired legs\u201d. In the same month, they provided another, seemingly pseudo-scientific advice: \u201cAnyone can experience the build-up of fluid in their lower legs! A quick test: press your finger against your shin bone for a few seconds. Can you see the marks made by your fingers? Quickly dial 080 30 25!\u201d <\/p>\n<\/div>\n\n

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Vita Vera’s Facebook add from 1 June 2016. <\/figcaption><\/figure>\n\n
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Concerned buyers<\/strong><\/h3>\n

A year later, in February 2018, Vita Vera\u2019s documents show that the company discussed a commission sale with Salus, a wholesale distributor for medical devices and medicines.<\/p>\n

In autumn, however, things did not go according to plan. On 23 November 2018, head of sales at Salus informed Vita Vera\u2019s representative that, despite his promises, he did not send his co-workers\u2019 clarifications as agreed in the meeting two weeks prior. Her concern due to possible non-compliance is evident from the e-mail. <\/p>\n

\u201cWe ask you to provide in writing the information about your decision how to proceed in the future, how to supply adequate and accurate information to our buyers who are asking us if your products are suitable for re-selling or should be returned.\u201d She added that Vita Vera\u2019s stock in the Salus\u2019 warehouse is blocked for sale as agreed at the meeting. <\/p>\n

Salus replied to our questions regarding the above e-mail that, in the case of Vita Vera\u2019s Silverline compression socks, they received the information that \u201cthe goods were classified as a commonly used product\u201d. When they received the information on possible non-compliance, the sale of socks was \u201cpreventively blocked\u201d. But when the company sent them the declaration of conformity, the socks were again available for sale. <\/p>\n

According to JAZMP\u2019s data, on 14 November 2018 Vita Vera submitted an application for the company to be entered in the register of manufacturers of medical devices and the socks into the register of medical devices. But only five days later, the legal representative of the company asserted in a letter to one of his former colleagues that this was definitely not a medical device but a commonly used product. <\/p>\n

If this were true, compression socks would not be classified as a medical device and would not have to be entered into the JAZMP\u2019s register. But this contravenes the applicable European directive which definitely defines this type of socks as a medical device. <\/p>\n

As stated by our source closely associated with Vita Vera, the company received enquiries from at least two Slovenian pharmacies in the first ten days of November 2018 if the Silverline compression socks were truly compliant with the regulations.<\/p>\n

This coincided in time with the meeting of the company\u2019s representatives at Salus which took place on 9 November as stated by the head of sales in the above e-mail. When this \u201ccommonly used product\u201d was entered into the register five days later \u2013 more than two years after the Silverline socks started being sold \u2013 it also officially became a medical device. <\/p>\n

Director: buyers do not report health issues<\/strong><\/h3>\n

Compression socks are supposed to improve blood circulation, alleviate tired and swollen legs, and relieve discomfort caused by varicose veins. Many patients are advised to buy them by their doctors. <\/p>\n

We asked the head of the Department of Dermatovenereology at the University Medical Centre Ljubljana (UKC Ljubljana), Tanja Planin\u0161ek Ru\u010digaj, if the clinic has any experience with Vita Vera\u2019s Silverline compression socks and if they recommend them to their patients. Through UKC Ljubljana\u2019s public relations office, we received her clarification that they know the manufacturer but that \u201cthey neither have experience with this company\u2019s products, nor they recommend these (or any other) socks\u201d. <\/p>\n<\/div>\n\n

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The patients should choose among manufacturers who do the measurements and adjust the socks accordingly, which is the most important.<\/p><\/blockquote>

\u2014 dr. Tanja Planin\u0161ek Ru\u010digaj<\/figcaption><\/figure>\n\n
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They do not recommend compression socks like Silverline\u2019s mostly because patients need a different type of socks. The doctors advise their patients that \u201cthey should choose among manufacturers who do the measurements and adjust the socks accordingly, which is the most important\u201d. (Vita Vera\u2019s socks are only available in basic sizes S, M, L and XL.) <\/p>\n

To the question if the sale of compression socks with a false CE marking could be problematic for the user of such a medical device, Planin\u0161ek Ru\u010digaj replied that she does not know \u201cif and what issues did or could arise\u201d in this case.<\/p>\n

In line with the law, a medical device manufacturer should appoint a person who is responsible for traceability and have an established vigilance system, i.e. a system that enables the device to be traced from the manufacturer to the patient and back, so that the former can eliminate any possible issues occurring during use.<\/p>\n

Vita Vera\u2019s director assured O\u0161tro.si that the company never received any complaints or \u201creports regarding health issues\u201d. We wanted to know how the company ensured traceability before it was entered into the register of manufacturers. <\/p>\n

\u201cSince its establishment, the company has two phone numbers dedicated to questions and possible complaints of clients. Buyers primarily call because they want to change the size, colour or model. To date, we did not detect any issues from a medical viewpoint because these are high-quality compression socks intended to alleviate the condition, which is also demonstrated in the technical documentation that we had before the certification.\u201d<\/p>\n

Silence on the CE marking<\/strong><\/h3>\n

We asked Mitja Perko, director and owner of Vita Vera, three times why the company has been selling the socks affixed with the CE marking for two years even though they were not fulfilling the legal requirements. Perko thoroughly clarified other aspects of the issue, but skirted around a direct reply to this question every time. <\/p>\n

His statements also included that he knows the reason behind our questions, namely two former employees who supposedly committed criminal offences and incurred damage to the company. When we asked him if he filed a criminal complaint against them, we did not receive a reply. <\/p>\n

It is therefore not clear what Perko\u2019s intentions were regarding his company selling a medical device \u2013 as everything points to \u2013 with a false CE marking.<\/p>\n

All EU countries are regularly dealing with falsely CE-marked products. A large group of controversial products comprises those produced in China and bearing the CE marking which, however, does not indicate conformity with European regulations but rather stands for \u201cChinese Export\u201d. The graphic design of the two labels is in fact very similar. And the products the competent authorities classify into the second group display the CE marking without fulfilling the pertaining legal requirements. <\/p>\n

In 2016, T\u00dcV Rheinland, a notified body in charge of certifying medicinal devices in Germany, explored in an article on its website why manufacturers lie about CE marking<\/a> and affix it to products that do not comply with the relevant regulations.<\/p>\n

The main reason cited was that the competent national authorities rarely verify the technical documentation of medical device manufacturers. This was followed by the lack of expert regulatory staff or training, the lack of test equipment and testing facilities and rushing to put a product on the market. <\/p>\n

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