22 12 19 extended approval time

The proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) is good news for CS MEDICA A/S.

CS MEDICA A/S (“CS MEDICA” or “the Company”) announces today that The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years, which is promising news for the company. It can give the company an additional four years ahead of competition. With patents and trademark protecting the company, a potential extension of the MDR transition will strengthen the company’s market position.

To address the concern of a potential shortage of medical devices, the cost of transition and low notified body capacity several key proposals were communicated to the Employment, Social Policy, Health, and Consumer Affairs Council. Amongst others the relevant transition periods for medical devices approved under the Medical Device Directive 93/42/EEC (MDD) should continue to apply until 2027 (for high-risk devices) and 2028 (for medium and low-risk devices), instead of currently May 2024.

Details of the specific legislative changes have yet to be announced and are expected to be defined and communicated finally in early 2023.

CS MEDICA’s advantage of a potential extension period.
CS MEDICA is a Danish MedTech company with a product portfolio regulated under the pharmaceutical regulation, Medical Device Directive (MDD), currently under transition to Medical Device Regulation (MDR).

CS MEDICA Research & Develop, Manufacture, and Distribute Medical device (MD) products and is hence categorized as a MedTech company, under the medical technology industry. The activities measured under the medical technology industry includes technologies, devices, diagnostic tests, and health information systems that are transforming health care through earlier disease detection, less-invasive procedures, and more effective treatments. MedTech is part of the pharmaceutical industry.​

A medical device in the case of CS MEDICA is defined as a medical technical product, used for medical purposes. Products in this category are among others designed to help treat or prevent medical conditions and diseases.

With a potential extension of the MDR transition the company gains additional years alone on the market as a first mover within over-the-counter medical products containing Cannabinoids. A significant competitive advantage is, if the Notify Bodies plan to firstly assess medical devices launched before May 2021, accounting 23.000 devices for assessment before the MDR deadline. Currently, only 2000 products have been assessed by a Notify Body since the MDR implementation in 2017[1].

Medical Device Directive (MDD) contra Medical Device Regulation (MDR)
The Medical Device Directive (MDD) and the Medical Device Regulation (MDR) are both European Union (EU) regulations that establish rules for the marketing and sale of medical devices in the EU. The main difference between the two is that the MDD is a directive, which means that it sets out general objectives and principles that must be followed by EU member states, while the MDR is a regulation, which means that it is directly applicable to all EU member states without the need for national implementing measures. The MDR also has more stringent requirements for the safety and performance of medical devices and the clinical evaluation of medical devices.

The MDR is generally considered to be more stringent than the MDD because it introduces several new requirements and strengthens existing ones. For example, the MDR increases the level of scrutiny for medical devices by introducing a new classification system and requiring more rigorous clinical data to support the safety and performance of devices. It also establishes a new regulatory framework for in vitro diagnostic medical devices and introduces new rules for the oversight of clinical investigations and post-market surveillance. Additionally, the MDR introduces new requirements for the traceability of medical devices and strengthens the role of notified bodies in the regulatory process. Overall, the MDR is designed to improve the safety and quality of medical devices and enhance patient protection.

Background for the extension of the transition period
At present, only 36 Notified Bodies are designated under the MDR for approval purposes. This is six more than on 14 June 2022. Based on the feedback from Notified Bodies to the latest survey in October 2022, Notified Bodies have/will receive around 25.000 applications from manufacturers and have issued 2000 certificates under the MDR. According to a rough estimation presented by Notified Bodies to the MDCG on 17 November 2022, the number of MDR certificates issued by May 2024 may reach around 7,000 if the current rate of certificate issuance continues with no changes to current conditions[i]. Therefore, the EU commission has suggested an extension of the transitional period in Article 120(3) MDR with staggered deadlines depending on the risk class of the device. Those deadlines could be 2027 for class III and class IIb devices (i.e. devices with a higher risk) and 2028 for class IIa and class I devices (i.e. lower risk devices) that need the involvement of a Notified Body in the conformity assessment[ii].
Besides these changes the proposal also includes: if needed for legal and practical reasons (including for access to third-country markets), the extension of the transitional period could be combined with an extension of the (free sales certificates) validity of certificates issued under Council Directives 90/385/EEC and 93/42/EEC by amending Article 120(2) MDR; Conditions to be fulfilled to ensure that the extension applies only to devices that do not present any unacceptable risk to health and safety have not undergone significant changes in design or intended purpose, and for which the manufacturers have already undertaken the necessary steps to launch the certification process under the MDR, such as adaptation of their quality management system to the MDR and submission and/or acceptance of the manufacturer’s application for conformity assessment by a notified body before a certain deadline (e.g. 26 May 2024);

The removal of the ‘sell off’ provision in Article 120(4) MDR and Article 110(4) IVDR, means that the CS MEDICA product line are allowed to stay on the maket in the extesion period. Regarding the urgent nature of the legislative initiative and the need for a swift adoption by the co-legislators for the changes to have the intended effect in a timely manner, the Commission considers that amendments should be kept to what is absolutely necessary at this moment in time.

Current status of CS MEDICA’s in the compliance of the new rules under the MDR
CS MEDICA is currently complying to the rules for MedTech companies in transition to MDR and finalizing the new updated MDR Technical Files for each medical device product incl. new classifications, new clinical trials and new clinical evaluation done by medical doctors. CS MEDICA have been in queue to Notify Body since May 2022 and are still waiting for the Notify Body to accept CS MEDICA as a client. This is a problem for the majority of the MedTech companies in EU, which has led the EU Commission to propose the delay of the deadline for the transition period to avoid shortage of medical device on the market.

If the proposal is approved and the specific legislative changes prolongs the MDR transition for MDs where the company’s portfolio is classified, the company can focus on smoother more cost-efficient transition, while growing its market position globally and be recognized for its innovative medical products and cutting-edge CBD technology ahead of competition four additional years.

[1] MDR was implemented on 26 May 2017 as part of the EU’s Medical Devices Regulation (MDR) 2017/745. This regulation replaces the previous Directive 93/42/EEC and updates the requirements for designing, producing, and marketing medical devices in the EU

[i] https://www.euractiv.com/section/health-consumers/news/commission-to-suggest-ways-out-of-medical-device-shortage/

[ii] ttps://ec.europa.eu/commission/presscorner/detail/en/SPEECH_22_7627

For more information about CS MEDICA, please contact:
Lone Henriksen, CEO
Phone: + (45) 71 20 30 47
Email: lh@cs-medica.com
Website: https://www.cs-medica.com/

CS MEDICA A/S is a Danish-based MedTech company committed to improving people’s lives with products that make a difference. We combine science, nature, and passion to deliver innovative alternatives with high efficacy and bioavailability to patients. From autoimmune to stress therapies, we aim to transform healthcare with more effective treatments.

We research, develop, manufacture, commercialize and brand over-the-counter (OTC) products under pharmaceutical legislation. Currently, 21 products with cannabidiol aimed at autoimmune and stress-related diseases have been developed. The first products reached Danish stores in 2020, and now 9 products are available on the European market at more than 500 points of sale. Another 12 products will be launched before the end of 2024, with 11 patent-pending products. The product line surpasses competing products on the market by being located at the intersection of natural products, science, and cannabinoid technology while being registered under pharmaceutical legislation.

CS MEDICA was recognized earlier this year as a company of Europe’s top 10 MedTech companies at European Lifestars Awards as the company both Research & Develop, Manufacture, Distribute and Brand life-supporting medical technologies. The additional research and innovation to develop cutting-edge CBD technologies allow us to lead in CBD medical advancements.