Medical device regulations differ significantly between the EU (MDR 2017/745) and the US (FDA 21 CFR 860), impacting market entry strategies, regulatory submissions, and compliance efforts.
EU (MDR) Classification:
Devices are categorized into four risk-based classes:
- Class I – Low risk (e.g., bandages, reusable surgical instruments)
- Class IIa – Medium risk (e.g., hearing aids, dental fillings)
- Class IIb – Higher risk (e.g., infusion pumps, ventilators)
- Class III – Highest risk (e.g., pacemakers, stents)
US (FDA) Classification:
Devices are classified into three groups, requiring different premarket pathways:
- Class I – Low risk (e.g., tongue depressors, gloves) – Mostly exempt from premarket notification
- Class II – Moderate risk (e.g., blood pressure monitors, powered wheelchairs) – Requires 510(k) clearance
- Class III – High risk (e.g., implantable defibrillators, artificial hearts) – Requires PMA (Premarket Approval)
Key Differences:
- EU: Focuses on conformity assessment with Notified Bodies. CE Marking required.
- US: FDA determines classification and clearance/approval pathways (510(k), PMA, De Novo).
- EU MDR has stricter clinical evaluation requirements than the previous MDD framework.
Why It Matters?
Understanding these differences is crucial for medical device companies navigating global markets, ensuring compliance, and expediting product approvals.
Read also: Medical Device Regulations in CANADA
Resource Person: Pratik Pawar