The European Association of Authorised Representatives (EAAR) holds its annual conference as an inclusive platform for all stakeholders across the medical and IVD medical devices landscape. The conference has a dedicated focus on the challenges faced by manufacturers and other stakeholders in embracing the EU MDR and IVDRs. We will delve into European Regulations, fostering insightful discussions on pivotal facets of these ever-evolving regulatory frameworks of the European Union, the United Kingdom and Switzerland.
Topics include:
- The divergence in national implementation of European regulations
- AI regulation
- Clinical evaluation
- UDI
- Post-market surveillance
- Technical documentation
