Submit offer SaMD Classification analysis of a digital mental health treatment program

• Cerebelo ApS        
• CVR nr.:  45820297
• For further questions, contact info:  Thomas Henriksen
• Phone and e-mail:  +45 30103504; thomas@cerebelo.dk

PRESENTATION OF COMPANY: 
Cerebelo develops digital psychological therapy treatment programs aimed at supporting individuals with mental health challenges. The solutions are designed to be accessible anywhere and anytime, and to provide evidence-based psychological support at a significantly lower cost than traditional in-person therapy.

The company’s products are built on established psychological methodologies and are intended to support mental health treatment through structured, self-guided digital programs.

Link to our website:
http://www.cerebelo.dk

Link to our program against anxiety (sold on co-founder’s private psychology clinic website):
https://www.otiliahenriksen.dk/webshop/selvterapeutisk_onlineforloeb_overkom_din_angst/
 
DESCRIPTION OF THE TASK UNDER MARKET EVALUATION: 
The objective of this task is to compile a comprehensive EU SaMD regulatory overview and an in-depth classification and device description for Cerebelo’s digital therapy program for anxiety.

The long-term ambition is to obtain EU MDR (CE) certification for the product. To support this, Cerebelo seeks an in-depth analysis that clarifies whether the product qualifies as a medical device under EU MDR, determines the appropriate classification, and outlines the regulatory pathway toward certification.

If the product is assessed to fall under Class IIa, the analysis should further describe what design, claims, or intended-use adaptations could enable a reclassification to Class I, in alignment with regulatory best practices.

The task is expected to cover, but is not limited to, the following elements:

·       Regulatory-grade product description

·       Intended purpose and claims inventory

·       Medical device qualification assessment and justification

·       SaMD classification rationale under EU MDR

·       Recommended regulatory pathway for the EU market (with optional perspectives on other markets)

·       Evidence strategy (clinical and technical)

·       High-level risk analysis summary (software-related and clinical workflow risks)

·       Data protection, cybersecurity, and privacy considerations

·       Overview of post-market surveillance (PMS) and change management strategy

·       Identification of additional relevant certifications or standards, if applicable

TASK OBJECTIVES AND SUCCESS CRITERIA: 

Objectives

The objectives of this task are to:

• Determine the applicable EU MDR classification for the digital mental health treatment program
• If classified as Class II, identify the preliminary requirements and strategic options that could support a reclassification to Class I, where feasible
• Provide a clear and product-specific overview of the regulatory requirements and certification pathway toward EU SaMD compliance
• Establish a solid regulatory understanding that can be used as a foundation for future certification planning

Success Criteria

The task will be considered successfully completed when:

• Cerebelo has a clear, supported and justified understanding of the product’s MDR classification
• The regulatory pathway and key compliance requirements are transparently documented
• Reclassification considerations (if relevant) are described in a constructive and actionable manner
• The analysis can be directly used as input for requirement specifications, budgeting, and future SaMD certification proposals

 
SPECIFICATION: 
We expect a written offer to include at least:

• A brief presentation of the bidder, stating the CVR number and contact details. If relevant, with references and history
• Bidder's proposal for solving the task
• Specification of the price for solving the task
• Discount, if relevant
• Timeframe and end date
• Conditions for the offer, if any 
   

BACKGROUND FOR THE TENDER: 
Beyond Beta is subject to a number of requirements for good, healthy financial management, including documentation that the agreed price for external purchases is an expression of the market price. This tender is part of these requirements. 
We emphasize that the bidder must only make an offer on the requested task.  Services of executing or implementing nature cannot be approved.