Regulatory assessment
EU Medical Device & IVD Assessment
Medical device or IVD: prepare the right regulatory assessment.
Intended purpose, product functions and market arrangements determine which medical regulatory questions need attention. This assessment structures qualification, classification, potential conformity pathways and evidence needs for your specific scenario.
Assess EU medical device and IVD qualification, classification, conformity pathways and the evidence needed for your product.
€399.00 incl. VAT
One assessment case · 180 calendar days of active editing access from purchase · two substantive report snapshots, each as a German and an English PDF.
Your practical benefits
Clarify intended purpose: Work through medical-device, IVD and borderline questions.
Understand the pathway: Identify classification questions and potential external involvement.
Prepare evidence: Structure clinical or performance evidence needs and other open actions.
From intended purpose to the next regulatory steps
A product idea alone does not resolve classification or conformity-pathway questions. The assessment connects the reported intended purpose and characteristics with supported MDR and IVDR routes. Borderline matters that cannot be resolved remain explicit specialist questions.
What you receive
A case-specific report covering the product profile, qualification and classification findings or unresolved candidates, potential conformity pathways, evidence needs and prioritised actions.
Two substantive report snapshots are provided for one case, each with a German and an English PDF. Retrieving an existing PDF does not create a new report snapshot.
How it works
- Describe the product, intended purpose, functions and market setup.
- Record available evidence, operator roles and lifecycle context.
- Review qualification, open specialist questions and the next procedural and evidence steps.
Who it is for
Manufacturers, product owners, Regulatory Affairs and quality teams working with medical devices and in-vitro diagnostics.
Good to know
No clinical diagnosis or treatment advice. The assessment does not replace a notified body, certification, clinical or performance studies, laboratory testing or a regulatory decision. Unverified dynamic source states are not presented as resolved.
The 180-day period covers active case editing and creating the included report snapshots. It does not promise continuous legal monitoring or determine data-deletion periods. The agreed retrieval entitlement applies to stored reports.
Frequently asked questions
Does the report certify the product?
No. It prepares regulatory decisions and evidence work; it is not a certificate.
What if classification remains uncertain?
The uncertainty and the specific specialist review needed remain visible.
Must I complete another assessment first?
No. Supported medical regulatory questions are addressed within this product’s own scope.
Related decision perspectives
Optional: free EU Market Check for a product
EU Market Access Assessment
Identify applicable EU product regulations, required compliance evidence and the next steps to bring your product to the EU market.
Product Release Readiness Assessment
Determine your product's regulatory release readiness, identify missing evidence and prioritize the actions needed before market launch.