Regulatory Strategy, Qualification & Classification

Correct qualification and classification determine the conformity assessment route, Notified Body involvement, evidence burden, QMS expectations and post-market obligations. NKB Regovanta establishes the regulatory basis before technical documentation is developed.

Define Your EU Regulatory Pathway

For MDR Medical Devices

Qualification as a medical device under the MDR framework

Intended purpose and clinical claims review

Application of MDR classification rules, including software (Rule 11) and special rules

Assessment of Class I, Is, Im, Ir, IIa, IIb and III pathways

Implantable, active, software, substance-based and custom-made device considerations

Conformity assessment route and Notified Body involvement

Borderline / combination-product considerations where relevant

For IVDR In Vitro Diagnostics

Qualification as an In Vitro Diagnostic (IVD)

Intended purpose, analyte/marker, population and clinical context review

Application of IVDR Rules 1–7

Assessment of Class A, B, C and D pathways

Multiple intended purposes and higher-class rule considerations

Companion diagnostic and high-risk classification considerations

Conformity assessment strategy, including higher-risk review expectations

Senior-Expert Differentiator

Classification Drives the Entire Evidence Roadmap

We do not stop at “what class is the product?” We ask what the classification means for evidence, clinical studies, QMS scope, Notified Body scrutiny, timelines and lifecycle obligations — and build the roadmap from that decision.

Conformity Route Matrix

MDR Annex IX / X / XI

QMS assessment, technical documentation assessment & product verification routes.

IVDR Annex IX / X / XI

Over 85% of IVDs now require Notified Body certification under Rules 1–7.

Need Classification Strategy?

Establish defensible MDR & IVDR classification rules before investing in dossier compilation.

Define Pathway

Establish Your EU Regulatory Identity with Absolute Certainty

Partner with our senior regulatory strategists to classify your device and select the optimal conformity assessment route.

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