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January 20, 2026
Approximately 5 minutes
Differentiation and Classification of Medical Devices in Germany (BfArM)
Differentiation and Classification of Medical Devices in Germany (BfArM)
Differentiation from Other Product Categories
BfArM assists in determining whether a product qualifies as a medical device under Article 2(1) MDR or falls under other regulatory regimes:
- Medicinal products: Principal mode of action is pharmacological, immunological, or metabolic (Directive 2001/83/EC).
- Biocides: Intended to destroy or control harmful organisms (Regulation (EU) 528/2012).
- Cosmetics: Primarily for cleaning, perfuming, protecting, or improving appearance (Regulation (EC) 1223/2009).
- Food/food supplements: Intended for ingestion with nutritional or physiological effect (Regulation (EC) 178/2002).
- Other borderline cases: E.g., products with both medical and cosmetic claims.
Manufacturers may request a formal differentiation decision from BfArM if classification is unclear. Differentiation and classification - BfArM
Risk-Based Classification under MDR
Medical devices are classified into four risk classes (I, IIa, IIb, III) based on Annex VIII MDR rules:
- Rule 1–4: Non-invasive devices (e.g., storage, channeling).
- Rule 5–8: Invasive devices (short/long-term, surgical).
- Rule 9–13: Active devices (energy source, diagnostic, therapeutic).
- Special rules: Absorbable, incorporating medicines/derivatives, or specific uses (e.g., contraception, disinfection).
Classification determines conformity assessment route: self-declaration for low-risk Class I vs. notified body involvement for higher classes.
Borderline and Classification Consultation
- For uncertain cases, manufacturers can submit a consultation request to BfArM (or relevant authority).
- Request includes product description, intended purpose, claims, mode of action, and justification.
- BfArM provides non-binding scientific opinion (binding decision possible in some cases via EU mechanisms).
- Timelines: Usually 3–6 months; urgent cases may be prioritized.
EU Coordination and MDCG Guidance
- BfArM participates in MDCG Borderline and Classification Working Group.
- Decisions align with MDCG guidance documents (e.g., MDCG 2021-24 on classification rules).
- EU-wide borderline manual and classification examples support consistent application.
Practical Advice for Manufacturers
- Use MDCG documents and BfArM checklists for self-assessment.
- Document rationale clearly for regulatory audits.
- Seek early consultation to avoid compliance issues.
- Classification impacts clinical evaluation requirements, QMS, and post-market obligations.
Correct differentiation and classification ensure appropriate regulatory scrutiny and patient safety under the EU MDR framework in Germany. Differentiation and classification - BfArM
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