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Beskrivning

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CS Medica är ett danskt medicintekniskt bolag, dedikerat till läkemedelsforskning, utveckling, tillverkning och global kommersialisering. Bolaget blandar vetenskap och natur för att förbättra patienters liv med cannabinoidterapier för smärtlindring, och för att hantera autoimmuna och stressrelaterade symtom. Globalt erbjuder CS Medica CBD-behandlingar över disk (OTC), inklusive patenterade medicinska produkter, MHRA och MDR-registrerade artiklar, under varumärket CANNASEN® eller med egen märkning.
2023-03-30 17:52:21

CS MEDICA ("CS MEDICA or The Company") a medical device manufacturer with leading CBD technology, has been approved by regulatory authorities to extend the transition period to the Medical Device Regulation (MDR) until end 2028. The extension comes as a relief to the Company and many other researchers and healthcare professionals concerned about the impact of the strict regulatory requirements on the availability of medical devices.

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The MDR, which came into effect in May 2017, replaces the Medical Device Directive (MDD) and imposes stricter regulations on medical device manufacturers. As a result, companies were required to prove that their products met the new standards, which involved significant testing and documentation. The Medical Devices Directive (MDD) was set to end on May 26th, 2020; however, due to the COVID-19 pandemic, this dated was postponed by one year to 26 May 2021, as many companies were unable to comply with the new regulations in time.

CS MEDICA has invested considerable resources into ensuring that its products comply with the new regulations. The company is committed to providing high-quality medical devices with cannabinoids that meet the needs of healthcare professionals and patients. The extension of the transition period will allow the company to continue selling its products without interruption until end of 2028.

"We are pleased to have been granted the extension to the MDR transition period," Lone Henriksen, CEO CS MEDICA, comments and continues, "This will allow us to continue to provide our customers with the medical devices they need while we work towards meeting the new regulatory requirements. We understand that the MDR is an important step toward ensuring patient safety, and we remain committed to complying with the new regulations. And as one of few with the therapeutical values of CBD within our field of autoimmune diseases and stress-related disorders, we are extraordinarily optimistic."

The decision to extend the MDR transition period will provide a much-needed buffer for medical device manufacturers to adapt to the new regulatory requirements. This will allow companies like CS MEDICA to continue to distribute their products without disruption. Researchers and healthcare professionals can continue to rely on medical devices from trusted manufacturers, ensuring that patients receive the best possible care.

Completing the MDR process
CS MEDICA already applied for the MDR process, and have completed all the required steps. The Company's MDR applications were sent to several notified bodies to onboard the Company as a new client for MDR rule 21 (devices composed of substances). CS MEDICA's application is now accepted by a Notified Body in the Netherlands and is in the progress of contract signing, which is expected to be finalized during April 2023.

MDR product timeline
  • MDR Technical file for Arthritis  gel (Class IIa ) - is ready for Notified Body
  • MDR Technical file for Wound gel (Class IIa ) - will be ready for Notified Body Q2-2023
  • MDR Technical file for Nasal gel (Class IIa ) - will be ready for Notified Body Q2-2023
  • MDR Technical file for Nasal Spray (Class IIa ) - will be ready for Notified Body Q4-2023
  • MDR Pain Patch (Class I)  - Q1-2023
  • MDR psoriasis gel (Class I) - Q1-2023

Clinical trials updates
CS MEDICA's clinical trials are performed on all products, including dermaceutical products, even though this is not requested. These clinical trials are performed according to International Council for Harmonisation (ICH) and ready for MDR classifications.

Finalized phase 3 studies:
  • Pain Patch
  • Protective Nasal gel
  • Arthritis gel
  • Psoriasis gel
In process, phase 3 study:
  • Nasal Spray Night (May finalized)
Finalized as in-vitro study:
  • Wound gel

Besides the clinical trials, the company have initiated and started Post market clinical follow up, which are implemented in CS MEDICA's CIM system (Clinical Information System).

The importance of MDR extending period[1]
The amendment of the MDR and the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out all steps, in accordance with the MDR and the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the `sell off' date in the MDR and the IVDR aims to prevent the disposal of devices.

Evidence and benefit of the extended MDR transition period 
The extension of the MDR transition period and the simultaneous extension of the certificate's validity is done automatically by law.

To the knowledge of the Board of Directors of CS MEDICA, the Company is currently the only one on the market with products that contain cannabinoids regulated under MDR. This immediately gives a competitive advantage, as new products introduced to the market under MDR with cannabinoids must undergo the process applicable to MDR Class IIa, and wait in the que for approval by the notified body.  Hence it is expected that  CS MEDICA will have a competitive advantage in the full extended transitional period, meaning at least until end of 2028.

[1]Reference to "Extension of the MDR transitional period and removal of the `sell off' periods",  and Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. By EUROPEAN COMMISSION March 2023 DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY.