| Regulatory changes (sections) | Potentially affected items evaluated in all survey questions (likert items) |
| Monitoring of Notified Bodies/ scrutiny process | Number of trials Costs Resource requirements Regulatory compliance Patient safety after product market entrance Patient safety during clinical trial Quality Innovations and product development Evidence requirements Sample size |
| Stricter requirements for Notified Bodies i.e. employee competence and designation of Notified Bodies | |
| Audit of manufacturers | |
| Cooperation between Notified Bodies and manufacturers | |
| Requirements of clinical evidence |