The regulation of medical devices is continually changing as more innovative technologies and drug-device combinations are being developed. Anyone involved in medical devices and in vitro diagnostics needs to keep up to date with both the new EU regulations and the clinical requirements.
Submissions for CE marking under the new MDR will need to satisfy more demanding clinical data requirements. Long-established devices on the market will not be exempt. For many devices, new data will have to be generated or collected retrospectively. How can manufacturers ensure they will have sufficient clinical evidence for different classes of devices?
On 02 October 2019 Factory-CRO's Project Manager & Data Protection Officer Alwin van den Broek will be attending this meeting and participate in this session and examine clinical data requirements for high-risk devices, and explore the uncertainties surrounding low-risk devices. . Click here to get in contact with us!
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Europe at the forefront of global healthcare regulation