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20 - 24 June 2022
Delivered as a Hybrid EventLive In-Person Event: 20-24 June 2022, Dublin, Ireland

20 - 24 June 2022
Delivered as a Hybrid Event,
Live In-Person Event: 20-24 June 2022, Dublin, Ireland

EU MDR, UKCA, SaMD: The Regulatory Landscape Is Evolving. Don’t Get Left Behind!

Navigate your regulatory hurdles and stay ahead with direct Competent Authority, Notified Body, legal and industry guidance.

EU MDR audits. EUDAMED. UDI Requirements. Economic Operators. NB Capacity. Digital Health. And more.

Navigate EU MDR and UK Regulatory Compliance With Expert Guidance

Regulatory Updates and Experiences

  • Lessons learnt on implementing the EU MDR with updates from the VP, Quality and Regulatory Affairs of Implantica
  • First feedback on Economic Operators with Stryker
  • Experience and updates on UDI and EUDAMED requirements with ConvaTec and Eudamed.eu
  • Get a status update on Brexit with the NHS Confederation

Competent Authority and Notified Body Feedback

  • Competent Authority feedback on the first 5 months of the EU MDR with German Federal Ministry of Health
  • Notified Body feedback from Intertek on EU MDR implementation
  • Early updates on the UKCA mark with BSI
  • Gain insights into the EU regulatory framework on AI and software from the EU Commission

Legal Advice For European Medical Device Regulations

  • UKCA and the UK(NI) mark: Will the UK become a dumping ground or a proving ground?
  • How do you deal with significant change for digital health products?
  • Common legal trip-points to avoid on the transference of CE marks
  • Economic Operators contract implementation