ServicesNotified Body readiness

Notified Body readiness for MDR and IVDR conformity assessment

Submitting early does not necessarily make CE marking faster. Incomplete or internally inconsistent documentation can result in extensive questions, additional evidence requests and repeated assessment cycles.

Fabola’s Notified Body Readiness service reviews the submission from the perspective of external conformity assessment and identifies issues that should be resolved before the file is handed over.

Who this is for

  • Manufacturers that have selected or are selecting a Notified Body
  • Companies approaching MDR or IVDR submission
  • Manufacturers with substantially complete technical documentation
  • Teams that want an independent pre-submission review
  • Companies that have received difficult Notified Body questions
  • Manufacturers trying to reduce avoidable assessment cycles

The problem it solves

  • Inconsistent intended-purpose wording
  • Weak classification rationale
  • Claims unsupported by evidence
  • Incomplete traceability
  • Risk management disconnected from validation or evidence
  • Inconsistent software documentation
  • Unclear clinical or performance conclusions
  • Missing regulatory justifications
  • Contradictory documents
  • Unanswered regulatory questions

Required inputs

  • Technical documentation index
  • Core technical documentation
  • QMS information
  • Risk-management documentation
  • Clinical or performance documentation
  • Verification and validation
  • Software documentation where applicable
  • PMS and vigilance documentation
  • Existing Notified Body questions, if relevant

What Fabola does

We perform a structured readiness review and identify issues likely to interfere with efficient conformity assessment. Where useful, the review can be conducted as a mock Notified Body assessment with likely assessor questions formulated explicitly.

Deliverables

  • Notified Body readiness report
  • Priority findings
  • Document-specific observations
  • Likely assessor questions
  • Evidence gaps
  • Recommended corrective actions
  • Submission-readiness checklist

Price

Focused pre-submission review

SEK 59,000

Review of a defined subset of documentation or one critical area before submission.

Single-device readiness review

SEK 79,000–99,000

Typical review of one device submission with cross-document consistency assessment and likely assessor questions.

Full technical documentation review

SEK 119,000–139,000

Detailed pre-submission review of a mature and extensive MDR or IVDR technical documentation package.

All prices are in SEK and exclude VAT.

Delivery time

Typical delivery: 2–4 weeks.

Completion point

The assignment ends when the agreed documentation has been reviewed and the manufacturer has a prioritised list of actions required before submission.

Exclusions

  • Guaranteeing certification
  • Predicting the decision of a specific Notified Body
  • Acting on behalf of the Notified Body
  • Rewriting all documents unless separately scoped
  • Executing missing validation or clinical studies

If further work is needed

Depending on the outcome, no further Fabola work may be required. You resolve the identified gaps and proceed to Notified Body submission. Where targeted support during assessment is needed, it is scoped separately.

Frequently asked questions

Can you guarantee that the Notified Body will not raise questions?

No. Notified Body assessors make their own conformity-assessment decisions. The purpose of the review is to identify avoidable gaps, inconsistencies and weak regulatory arguments before submission.

Can you review only one part of the technical file?

Yes. A focused review can cover a defined area such as clinical evidence, software documentation, risk management or a response package to existing Notified Body questions.

Can you perform a mock Notified Body review?

Yes. Where appropriate, Fabola can structure the review around the questions an external assessor is likely to ask and provide a prioritised response plan.

Should we do this before signing with a Notified Body?

It can be useful either before or after selecting a Notified Body, provided the planned conformity assessment route and product scope are sufficiently clear.

Primary regulatory sources

Last reviewed: September 2026

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Ready to define the work?

Tell us what the product is, where the project stands and the regulatory question you need answered.

We will confirm whether this service fits, or point you to a better starting point.

Discuss your Notified Body readiness

The first conversation is free and carries no commitment.