Transferring data outside the EU: the Court of Justice sets new boundaries (and why it matters for the medical devices sector)
3D-printed medical devices and data protection obligations
A new corporate warranty role: the person responsible for compliance
Medical devices, data protection, and cybercrime: the three challenges of new software
Apps and telemedicine in view of the new MDR
Timelines and validity of certificates in the light of the new Medical Devices Regulation
What is the validity of certificates issued by Notified Bodies and how long can the related MDs be marketed? What are the rules of the transitional period? The companies in the medical devices sector have many questions concerning the implementation of the new Regulation on medical devices.
What changes in the classification of medical devices with the new EU Reg. 2017/745 (MDR)?
One of the first activities that the manufacturer has to carry out is to decide whether, in the light of the new MDR, a product falls within the definition of a medical device and, if so, whether the risk class of the medical device has changed.
Is it admissible to display eyeglasses prices in optical store windows in Italy?
Healthcare advertising is a complex field, where it is necessary to mediate between the effective promotion of a product and a correct and appropriate communication, in accordance with the existing legal framework.
Person responsible for regulatory compliance
The 745/2017 Regulation on Medical Devices introduces the figure of the Person Responsible (PR), with the aim of giving this figure greater authority and importance to the Responsible / Regulatory Officer within the medical device company organization.