Table 2.
Characteristics of new devices granted Conformité Européenne (CE) marking between 2005 and 2010
| Novel medical devices (n=309) | No (%) |
|---|---|
| Therapeutic area: | |
| Cardiovascular | 245 (79) |
| Neurologic | 28 (9) |
| Orthopedic | 36 (12) |
| CE marking year: | |
| 2005 | 29 (9) |
| 2006 | 37 (12) |
| 2007 | 36 (12) |
| 2008 | 57 (18) |
| 2009 | 79 (26) |
| 2010 | 71 (23) |
| Firm type: | |
| Small (<$1bn) | 134 (44) |
| Large (≥$1bn) | 174 (56) |
| Food and Drug Administration approval: | |
| Yes | 206 (67) |
| No | 103 (33) |
| Major innovation: | |
| Yes | 75 (24) |
| No | 234 (76) |