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CS MEDICA, Pioneering the Transition to MDR, Sign Contract with a Notified Body in Europe, Safeguarding Their Medical Device Product Line's Market Presence
CS MEDICA A/S ("CS MEDICA" or "The Company"), a global MedTech company specializing in relieving symptoms of autoimmune diseases and stress-related disorders, is a first mover of CE-marked medical devices with CBD in the MDR (Medical Device Regulation[1]) transition grace period until 2028.
The Company's competitive advantage has been strengthened as CS MEDICA now secured its position by being one of the first companies in the European Union to sign with a Notified Body, to fulfill the required steps under Rule 21[2] toward compliance with the new regulations.
"We are proud to announce CS MEDICA signed with the Notified Body in the Netherlands, which can help us secure the transition to MDR and is to issue the CE MDR certificate for the products. This achievement showcases our dedication to maintaining the utmost quality and safety in our products, while also demonstrating our commitment to meeting the rigorous requirements set forth by the New MDR regulation", states Lone Henriksen, CEO and co-founder, CS MEDICA A/S.
Lone continues; "It is further a true cornerstone for our company's global growth plans, especially partnering with Big Pharma players and positioning our company closer to the medicine industry long-term."
[1] About MDR - Read more from public references as: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32023R0607 or https://medicoindustrien.dk/article/nyt-om-mdr-udsaettelse-af-overgangsfase-mdr-stemt-igennem-af-eu-parlamentet or https://www.greenlight.guru/blog/questions-about-european-mdr-answered
[2] The EU-MDR Rule 21 - devices composed of substances or of combinations of substances to be introduced into the human body via a body orifice or applied to the skin and absorbed by or locally dispersed in the human body. Impacted manufacturers are seeing their products up classified to Class IIb shifting their regulatory requirements, in some cases, from self-declared Class I to full conformity assessment procedures with notified body involvement. Reference: https://health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf
This disclosure contains information that CS MEDICA A/S is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 15-06-2023 13:26 CET.