Healthcare companies often begin product development without absolute clarity on whether their product is a general wellness product or a regulated medical device.
That distinction is not cosmetic; it defines whether regulations apply at all, and if they do, how deep, how costly, and how long or complex the regulatory journey will be.
At Elexes, product classification starts with the right first question. Is your product truly a general wellness product, or is it a medical device? Only after that is clearly established do we move into medical device classification and regulatory pathways.
This two-step approach saves time, prevents rework, and avoids costly regulatory missteps.
General Wellness vs Medical Device
Before discussing medical device classifications, regulatory classes, or submissions, every healthcare product must first be placed into the correct product category.
This is a separate and essential service.
A product can only follow medical device regulations if it qualifies as a medical device. A wide range of products, particularly digital health products, wearables, software, and AI solutions, are often found in the gray area between consumer wellness and regulated healthcare.
The boundary separating the two is primarily set by the following factors:
⦿ Intended use
⦿ Claims (explicit and implied)
⦿ Target users and user context
⦿ Functional impact on diagnosis, treatment, monitoring, or prevention
If this step is skipped or handled incorrectly, companies face the following risks:
⦿ An unnecessary regulatory burden
⦿ Delayed product launches
⦿ Reclassification by regulators after the product has entered the market
⦿ Enforcement actions due to unintended medical claims
Elexes makes a decision whether your product can be labeled as a general wellness product or as a regulated medical device based on the following guidelines:
⦿ The product’s intended use and marketing
⦿ The claims made through sales, labels, and promotions
⦿ The software’s capabilities and what it generates
⦿ The users’ actions and the support they receive in making decisions
⦿ The extent to which your product resembles the general wellness guidelines and the established regulations
We assess whether your product:
⦿ Encourages or supports general health and lifestyle awareness without medical intent, or
⦿ Diagnoses, treats, mitigates, monitors, or prevents a disease or condition
Outcome of Step 1
At the conclusion of this step, you will have:
⦿ A determination of product category that is clear and indisputable
⦿ A written rationale that is in accordance with regulatory expectations
⦿ Guidance that is practical and based on understanding claim boundaries and positioning
If your product is confirmed as a general wellness product, no medical device regulations apply. If your product is confirmed as a medical device, we then move to Step 2.
General wellness is not a label you assign once and forget. It is a regulatory position that must be earned and re-earned—as your product evolves.
⦿ Adding new features that would make the product medical
⦿ Marketing the product in a way that suggests it could diagnose or treat
⦿ Updating the software increases the risk level
⦿ Users in the real world are using the product in a way that is beyond what was originally thought
Any of these can unintentionally push a wellness product into medical device territory.
Wellness can be a deliberate early-stage strategy when managed correctly.
Teams can:
⦿ Start with a general wellness positioning
⦿ Learn from real-world use and user behavior
⦿ Build technical, performance, and usability evidence over time
The same data that supports lifestyle awareness today can later form the basis for:
⦿ Observational studies
⦿ Clinical validation
⦿ Transition into a regulated medical device pathway
Elexes helps companies design this evolution intentionally, without triggering premature regulatory exposure.
After a product is confirmed as a medical device, the following question arises. What type of medical device is it, and which regulatory pathway applies? This is a distinct service from wellness determination.
The classification of a medical device defines:
⦿ Risk class
⦿ Regulatory burden
⦿ Approval timelines
⦿ Evidence expectations
⦿ Post-market obligations
An incorrect classification can:
⦿ Delay approvals
⦿ Increase costs unnecessarily
⦿ Trigger regulatory non-compliance
Elexes applies a structured, regulator-aligned methodology to determine medical device classifications globally.
We evaluate key factors that determine a product’s regulatory classification, including:
⦿ Confirmed medical purpose
⦿ Intended user population
⦿ Clinical claims that influence classification decisions
Devices are classified using jurisdiction-specific rules, including:
⦿ EU MDR Annex VIII
⦿ FDA risk-based principles
⦿ Health Canada classification rules
⦿ TGA classification framework
⦿ India CDSCO risk-based classification
⦿ UK MDR risk-based classification
When it comes to the study of hardware, software, AI, and combination products, the assessment is done in the following manner:
⦿ Primary mode of action
⦿ Technological complexity
⦿ Software risk contribution
Borderline products undergo a review process that considers:
⦿ Published guidance,
⦿ Precedent decisions
⦿ Regulatory interpretations.
We verify the proper pathway, which includes:
⦿ FDA 510(k), De Novo, PMA, or exemption
⦿ EU MDR conformity route and CE marking
⦿ Health Canada Medical Device License
⦿ TGA inclusion in the ARTG
The following infographics simplify how medical device classifications link to regulations and submissions.
As outlined in the table above, different regulatory pathways are pursued based on product classification, and upon successful authorization, well-recognized certifications or markings, such as UKCA, CE marking, FDA approval, or FDA clearance, may be used, as applicable.
To identify the applicable regulatory pathway for your product
If you are a healthcare company building healthcare products, you must know:
⦿ Whether your product is a general wellness product or a medical device, and
⦿ If it is a medical device, how is it classified and regulated in each target market
If you are unsure whether your product is a wellness or a medical device, we help you determine that first.
If it is confirmed as a medical device, we then classify it correctly and define the right regulatory pathway.
This approach saves companies significant time, cost, and regulatory rework.
For the teams that manage the classification decisions internally, Elexes provides targeted RAQA training programs:
⦿ Medical Device Classification Training
⦿ EU MDR & IVDR Classification and Conformity Routes
⦿ FDA Regulatory Pathways (510(k), De Novo, PMA, Exemptions)
⦿ ISO 13485 and its impact on classification decisions
⦿ Health Canada and TGA classification frameworks
Start with clarity. Move forward with confidence.
Product classification defines whether regulations apply at all, and if they do, which regulatory requirements, submissions, and evidence are required.
No. Determining wellness vs medical device is a separate step that must be completed before medical device classification.
Yes. Many products start as wellness and transition to medical devices as evidence and functionality evolve.
Yes. Medical device classifications and pathways differ across the FDA, EU MDR, Health Canada, CDSCO, MHRA, and TGA.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
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