ServicesMDR and IVDR readiness

MDR and IVDR readiness assessment

Fabola’s MDR & IVDR Readiness service assesses how far a medical device or IVD manufacturer has progressed towards a coherent conformity assessment package. It answers a practical question: what is complete, what is missing, what matters most and what should happen next?

The review looks beyond whether individual documents exist. It assesses whether the regulatory strategy, technical documentation, evidence, risk management and QMS tell the same regulatory story.

Who this is for

  • Manufacturers that have started technical documentation
  • Companies preparing for ISO 13485 certification
  • Companies preparing to select or approach a Notified Body
  • Teams transitioning from development into regulatory submission
  • Companies with fragmented or inherited regulatory documentation
  • Manufacturers that want an independent review before committing to a submission date

The problem it solves

  • Intended purpose differs between documents
  • Classification is weakly justified
  • Requirements are not traceable
  • Risk management and clinical or performance evidence are disconnected
  • Verification and validation do not support the stated claims
  • The QMS exists but is not aligned with the product lifecycle
  • Technical documentation is detailed but difficult to assess as one coherent file

Required inputs

  • Intended purpose and classification rationale
  • Technical documentation index
  • Quality-management documentation
  • Risk-management file
  • Product and software requirements
  • Clinical evaluation or performance evaluation material
  • Verification and validation reports
  • Usability and human-factors documentation where relevant
  • PMS and vigilance documentation

What Fabola does

We conduct a structured gap assessment against the relevant MDR or IVDR requirements and the planned conformity assessment route. The review assesses both document presence and cross-document coherence.

Deliverables

  • Readiness assessment
  • Document-by-document gap analysis
  • Critical, major and lower-priority issues
  • Prioritised action list
  • Dependencies between activities
  • Recommended sequence of work
  • Proposed route to submission readiness

Price

Focused readiness review

SEK 49,000

Early-stage manufacturer with partial regulatory documentation. Focuses on regulatory strategy, core documents, evidence structure and a prioritised action plan.

Submission readiness review

SEK 69,000–89,000

Manufacturer with substantial technical documentation preparing for conformity assessment. Includes cross-document consistency and submission-critical gaps.

Full technical documentation review

SEK 119,000

Detailed readiness review of a mature MDR or IVDR technical documentation package before submission.

All prices are in SEK and exclude VAT.

Delivery time

Typical delivery: 2–4 weeks, depending on document volume and agreed scope.

Completion point

The assignment is complete when the readiness report and prioritised regulatory action plan have been delivered and reviewed with the client.

Exclusions

  • Rewriting the complete technical documentation unless separately scoped
  • Execution of laboratory, software or clinical testing
  • ISO 13485 certification
  • Notified Body certification
  • Guarantees regarding the outcome or timing of conformity assessment

Likely next step

The next step is normally one or more targeted work packages: Clinical & Performance Evidence, AI Validation & Evidence, technical-documentation remediation or Notified Body Readiness.

Frequently asked questions

Is this the same as an MDR or IVDR checklist?

No. A checklist confirms whether expected documents exist. The readiness assessment also looks at whether the intended purpose, claims, risks, evidence, validation and post-market strategy are coherent across the documentation.

Can you review an incomplete technical file?

Yes. The focused readiness review is specifically designed for companies that have started the regulatory work but do not yet have a complete submission package.

Will you tell us what to fix first?

Yes. The output is prioritised so the team can distinguish submission-critical issues from lower-priority improvements and understand dependencies between tasks.

Does a positive readiness review guarantee certification?

No. Final conformity assessment decisions remain with the designated Notified Body and other competent actors. The review is intended to reduce avoidable gaps and improve submission readiness.

Primary regulatory sources

Last reviewed: September 2026

Other services

Classification and conformity pathway

Is my product a medical device or IVD, what class is it, and what do I need to do to place it on the EU market?

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.