It will be illegal to place a medical device on the market after 21 March 2010 if it does not comply with the new requirements of Directive 2007/47/EC.
There are significant new requirements related to:
- Essential requirements
- Classification
- Clinical investigation
- Authorised representation
- …and much more
AbNovo can:
- Provide you detailed advice on the new compliance requirements.
- Train your staff on the new requirements.
- Audit your compliance.