Webinar: Medical Device Regulation of Annex XVI Products

Nicole Small

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Nicole Small

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Learn about our Engaged Experts

Nicole is a highly experienced regulatory professional with a depth and breadth of experience in the safety, performance, and regulation of medical devices – a career spanning over 30 years.

About the webinar

Element’s medical device expert, Nicole Small, will deliver an on-demand webinar, on the relevant requirements of EU MDR Annex XVI products. 

The webinar will discuss key regulatory requirements and activities by economic  operators of Annex XVI products without an intended medical purpose. It will establish a foundation of knowledge that can be expanded upon in practice. 

Learning outcomes

Participants will be able to:

  1. Identify if your product falls under Annex XVI
  2. Develop an understanding and awareness of key aspects of the Regulations and common specifications that apply to your products in the pre-market and post-market phases.
  3. Critically evaluate the regulatory requirements, including the cumulative requirements if a device has a medical and non-medical purpose
  4. An awareness of advertising/marketing rules

Who should attend?

People involved in the manufacture, import or distribution of Annex XVI products within the EU and Northern Ireland, including:

  • Regulatory affairs teams and managers
  • Quality teams and managers
  • Compliance managers / Person Responsible for Regulatory Compliance
  • Medical device developers
  • Aesthetic product developers

Fill in the form below to watch the webinar on-demand, or contact our experts if you have any questions.

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