The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…
The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…
The first speaker was Amy Bennet, who highlighted that any coordinated clinical assessment requires sound data gathered from preclinical development, especially in class IIa, IIb and above devices.
Martin Witte chaired and introduced this interesting session, which considered the digitalisation of medical device regulatory information –using technology to allow more effective interrogation and control of available data…
The first speaker for this session was Derek Foit. He defined legacy devices per Article 120 MDR, provided examples of class I to class III devices including nanoparticles, nasal sprays as specific cases…
This session looked at the practicalities of IVDR implementation and considered how to prepare application documents, the expectations for performance evaluation (PE) and postmarketing clinical follow-up (PMCF).
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.