Device Classification under MDR (Annex VIII)

Correct MDR classification is the foundation of your EU compliance strategy. It determines the conformity assessment route, whether a Notified Body is required, the depth of technical documentation and the clinical evidence expectations.

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Risk Classes (MDR)

MDR uses four main risk classes:

• Class I — low risk (often self‑declaration; some subcategories require Notified Body involvement)
• Class IIa — medium risk
• Class IIb — medium to high risk
• Class III — highest risk (e.g., many implantables and high‑risk technologies)

How Classification Is Determined

Classification is determined by applying the 22 classification rules in Annex VIII of MDR. Key drivers include:

• Intended purpose and claims
• Duration of contact with the body
• Invasiveness and anatomical site
• Active vs. non‑active nature
• Special rules (e.g., software, substances, nanomaterials)

Why Classification Matters

• Conformity assessment route selection (and Notified Body need)
• Technical documentation scope (Annex II/III expectations)
• Clinical evaluation depth and evidence strategy — see Clinical evaluation
• PMS/PMCF requirements and post‑market obligations

Common Classification Pitfalls

• Claims and marketing language unintentionally increasing risk class
• Borderline products (device vs. non‑device) and accessory status
• Software classification and intended purpose definition
• Misunderstanding invasiveness/duration and applicable rules

What We Deliver

• Classification assessment and recommended class
• Documented classification rationale (rules justification)
• Notes on borderline considerations and assumptions
• High‑level guidance on the conformity assessment route

Planning MDR certification next? See MDR certification.

What We Need From You

• Device description, intended purpose, variants/SKUs
• Labeling/IFU and marketing claims
• How the device works (including software features, if any)
• Contact duration and invasiveness details
• Any similar products / existing regulatory history (if available)

Classification confirmation via SÚKL (CZ)

If you need an official confirmation of classification in the Czech Republic, we can support you with preparing and submitting a request to SÚKL (State Institute for Drug Control) and coordinating the process.

• Review of intended purpose/claims and supporting rationale
• Preparation of the request package and supporting documentation
• Submission coordination and communication support

Service price: 890 EUR

Questions?

See our FAQ page for quick answers about MDR and IVDR.

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