Clinical data the evaluation of clinical data is required for all medical devices. Clinical experience with are these data from reports on medical product related, must prove that it is the product in question or a similar product, which is similar to the concerned product. Also experience or clinical data to the product of the phase must be checked after its placing on the market on their clinical relevance. A revision of the existing technical documentation technical documentation that can change the requirements require . Declaration of conformity are true to the changes of the basic requirements for your product and these are not through the existing Technical documentation satisfies, since March 21, require a new declaration of conformity. In the other case you can demonstrate that your product has previously met the new requirements.
Notified bodies recommend a new declaration of conformity to exhibit, to avoid misunderstandings in the end anyway. Implement the changes document have exactly, what differences you noticed you and what measures they corrected you. The notified bodies expect a detailed verification in relation to the implementation of the requirements of the new directive. Under most conditions Dale Atkins, Ph.D. would agree. This includes a review of your QM-system. If you have any questions or need assistance in the implementation of EC Directive 2007/47/EC or their review, you can reach us at any time at. We offer also a guideline for the monitoring of the update of the EC directive for medical devices 93/45/EEC for this purpose, with which you step by step which can check relevant amendments to the medical devices directive and fill existing gaps in the documentation for you.