Regulatory roadmaps by market and class
Each pathway lists, in order, the phases and steps that take a device to market: classification, economic operators, technical documentation, quality system, notified body, CE marking, EUDAMED, surveillance. The structure is public; the detailed guide for each step lives in Normiq.
European Union
- Class I medical device14 phases · 61 steps · estimated duration 210 days
- Class IIa medical device15 phases · 64 steps · estimated duration 240 days
- Class IIb medical device14 phases · 64 steps · estimated duration 360 days
- Class III medical device14 phases · 64 steps · estimated duration 540 days
- Class A IVD14 phases · 55 steps · estimated duration 90 days
- Class B IVD15 phases · 59 steps · estimated duration 180 days
- Class C IVD15 phases · 61 steps · estimated duration 270 days
- Class D IVD15 phases · 63 steps · estimated duration 360 days
Switzerland
- Class I medical device14 phases · 69 steps · estimated duration 60 days
- Class IIa medical device15 phases · 72 steps · estimated duration 120 days
- Class IIb medical device15 phases · 75 steps · estimated duration 180 days
- Class III medical device15 phases · 75 steps · estimated duration 270 days
- Medicinal product11 phases · 40 steps
- Class A IVD15 phases · 55 steps · estimated duration 60 days
- Class B IVD16 phases · 59 steps · estimated duration 90 days
- Class C IVD16 phases · 61 steps · estimated duration 135 days
- Class D IVD16 phases · 63 steps · estimated duration 180 days
European Union and Switzerland
- Class I medical device15 phases · 75 steps · estimated duration 240 days
- Class IIa medical device16 phases · 78 steps · estimated duration 300 days
- Class IIb medical device16 phases · 81 steps · estimated duration 420 days
- Class III medical device16 phases · 81 steps · estimated duration 630 days
- Medicinal product11 phases · 44 steps
- Class A IVD15 phases · 58 steps · estimated duration 120 days
- Class B IVD16 phases · 62 steps · estimated duration 225 days
- Class C IVD16 phases · 64 steps · estimated duration 330 days
- Class D IVD16 phases · 66 steps · estimated duration 450 days