ServicesClassification and conformity pathway

Medical device and IVD classification and conformity assessment pathway

Before building a technical file, commissioning a clinical study or approaching a Notified Body, a manufacturer needs a defensible regulatory pathway. Fabola’s Classification & Conformity Pathway service determines whether the product falls within the MDR or IVDR, how the intended purpose should be expressed, which classification rule applies and what conformity assessment route is required.

The output is a written regulatory position that can be used to plan product development, validation, quality management and CE marking.

Who this is for

  • MedTech and HealthTech startups
  • Software and AI companies entering healthcare
  • IVD developers
  • Existing manufacturers launching a new product
  • Non-European manufacturers planning EU market entry
  • Investors, incubators or accelerators assessing regulatory feasibility

The problem it solves

A regulatory strategy built on the wrong intended purpose, qualification or classification can create substantial downstream work. Common questions include:

  • Is this wellness software or medical device software?
  • Does the software meet the MDR definition of a medical device?
  • Does the product meet the IVDR definition of an in vitro diagnostic medical device?
  • Which MDR or IVDR classification rule applies?
  • Does Rule 11 apply to this medical device software?
  • Will a Notified Body be required?
  • Can the manufacturer self-declare conformity?
  • What does CE marking require for this product?

Required inputs

Early-stage products are welcome. Final technical documentation is not required.

  • Product description
  • Proposed intended purpose
  • Target users and use environment
  • Target patient or tested population
  • Description of functionality
  • Inputs, outputs and results produced by the product
  • Clinical, diagnostic or performance claims
  • Existing website, pitch deck, prototype material or product requirements

What Fabola does

We qualify the product under the MDR and/or IVDR, review the intended purpose and recommend wording, and analyse which classification rule applies and why.

From there we set out the conformity assessment route and the likely Notified Body involvement. We also identify the major evidence and QMS implications, along with any assumptions and unresolved regulatory questions.

Deliverables

You receive a concise Regulatory Classification & Conformity Pathway Report containing:

  • Regulatory qualification
  • Recommended intended-purpose wording
  • Classification and applicable rule
  • Written rationale
  • Conformity assessment pathway
  • Expected Notified Body involvement
  • Major evidence and QMS implications
  • Key assumptions and unresolved questions
  • Recommended next steps

Price

Standard pathway

SEK 29,000

One product and one intended purpose where the main task is qualification, classification and conformity assessment route.

Complex pathway

SEK 49,000–59,000

AI, multiple functions or claims, borderline medical/wellness positioning, MDR/IVDR ambiguity or another material regulatory interpretation issue.

The price is confirmed before the assignment begins. There is no hourly billing within the agreed scope.

All prices are in SEK and exclude VAT.

Delivery time

Typical delivery: 7–10 business days after receipt of the required product information.

Completion point

The assignment is complete when the agreed report has been delivered and discussed in one review meeting.

Exclusions

  • Complete technical-documentation authoring
  • QMS implementation
  • Clinical evaluation or performance evaluation writing
  • Software or laboratory validation
  • Notified Body submission preparation
  • Formal legal opinion

Likely next step

For early-stage companies, the next step is usually MDR / IVDR Readiness or Clinical & Performance Evidence Strategy.

Frequently asked questions

Is medical device software automatically Class IIa under the MDR?

No. Classification depends on the intended purpose and the applicable MDR classification rules. Rule 11 is particularly important for medical device software, but the correct class must be determined from the specific function and consequences of the information or decisions the software supports.

Do I need a Notified Body?

It depends on the regulatory classification and conformity assessment route. Many medical devices above Class I and many IVDs require involvement of a designated Notified Body.

Can you classify a product before it is fully built?

Yes. Classification can and often should be addressed early, provided the intended purpose, core functionality, target user and claims are sufficiently defined.

Can you help decide whether a wellness product becomes a medical device?

Yes. The analysis focuses on intended purpose, claims, functionality and the applicable legal definitions. The output explains the regulatory rationale and the consequences of each positioning choice.

Primary regulatory sources

Last reviewed: September 2026

Other services

MDR and IVDR readiness

How far are we from being ready for CE marking under the MDR or IVDR?

Clinical and performance evidence

What evidence do we actually need to support our medical device or IVD?

AI validation and evidence

How do we demonstrate that our AI-enabled medical device works reliably and safely for its intended medical use?

EU AI Act + MDR / IVDR

How does the EU AI Act interact with the MDR or IVDR for our product?

Notified Body readiness

Are we ready to submit to a Notified Body?

Regulatory intelligence

We have one defined regulatory question. Can you answer it without turning it into a six-month consulting project?

PRRC

Do we need a Person Responsible for Regulatory Compliance, and can Fabola fulfil that role?

What are you building?

Whether you have an idea, a prototype, a working product, a validation study underway or a Notified Body submission approaching, we can start with the decision you need to make now.

You do not need to know which regulatory service to ask for.

Talk to Fabola

Send us a short description of your product.