RAPS Regulatory Convergence


This annual event hosts the global regulatory community and brings together regulatory professionals to share knowledge while addressing all things relevant to the dynamic medical device, pharmaceutical and biotech industries.

Don’t miss our presentations:

Thursday, October 4 – 2:00 – 3:00 pm – Theresa Jeary – Head of Notified Body – Medical Devices

Combination Products in the EU: Impact of Article 117 of the Medical Device Regulation (MDR) on the Pharmaceutical Industry

Theresa will help you understand the requirements of Article 117 of the Medical Device Regulation while recognizing the specific roles of key stakeholders, plus:

  • Explaining what documentation is required by a Notified Body
  • What to expect from the process
  • What are some post-opinion change management details and communication requirements between stakeholders

Thursday, October 4 - 5:00pm – Nick Baker – IVD Head of Notified Body

Navigating through Technical File Sampling in the In Vitro Diagnostic Device Regulation (IVDR)

The In Vitro Diagnostic Device Regulation (IVDR) introduces the concept of technical file sampling, Nick will:

  • Put forward a rationale to determine the number of technical files to be sampled
  • Discuss the expectations of a technical file review
  • Define Class C and Class B devices

Stop by booth #506 to find out more about these topics and talk to our medical device experts.

Stay tuned for more information on presentation #3 !