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Keeping you up to date – Regulations on Medical Devices
November 3, 2020 @ 3:00 pm – 3:30 pm
Speaker: Camilla Ravazzolo, EFAMRO
Convenor: Bernadette Rogers, General Manager EphMRA
Description: Working in the devices and diagnostics arena means that increasingly you need to be aware of upcoming changes in regulations. This webinar is aimed at making sure you are well informed.
What are the implications of the New European Union Medical Device Regulation? The Medical Devices Regulation (MDR) represents a significant development of the existing regulatory system for medical devices in Europe. The new MDR now requires total life cycle traceability between all stages of product development and post-market activities. Companies with low-risk Class I devices are required to produce a post-market surveillance report. The European Commission delayed the Regulation implementation, and 26 May 2021 is now the official date of full application.
How will the UK structure its post-Brexit legislation? From 1 January 2021 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system. The MHRA has established five strategic goals for 2020-21 that will impact all those operating in the UK medicines and medical devices industries. For Northern Ireland, different rules will apply to those in Great Britain after the transition period.
This webinar will give you an introduction to the background to the new arrangements and what you need to know to get ready for the changes ahead.
Camilla Ravazzolo, Head of Policy and Standards
Camilla Ravazzolo is a Lawyer and a Privacy Enthusiast. She works at EFAMRO as Head of Policy and Standards, providing support to members on an array of European and international conundrums. She has an extensive background in EU affairs working for the European Court of Justice in Luxembourg and with the EU Institutions in Brussels. She holds a LL.M from the University of Luxembourg and a MA from the College of Europe, Bruges.