Health Valley Event 2021

10 & 11 March

CO-FIT FUTURE

Programme

MDR

Marilyn Monroe Foyer 16:15 - 17:00

The Medical Device Regulation (MDR) will be effective as from 26 May 2020. Compliance with this new MDR is mandatory for all medical devices to enter the European market.

The new MDR introduces many changes, including new definitions, reclassifications, new notified body designations and more. Stricter requirements on safety, on clinical evidence and on consistency in regulatory compliance.

We are organizing an interactive workshop to inform innovators about the steps to be taken in implementing the new rules.

Topics that will be covered during this session are:
• The latest news about the MDR
• Stricter requirements for Notified Bodies
• Clinical evaluation
• Clinical studies
• Post Market Clinical Follow-up (PMCF)
• Patients and healthcare professionals have access to a European database with information about medical devices on the European market (EUDAMED)
• Post Market Surveillance (PMS)

The workshop will be provided by Peter Reijntjes, Qserve Consultancy B.V. and Maroeska Rovers, Hi-NL & Radboudumc.

At this workshop you have the opportunity to ask specific questions, but also to hear from others and share experiences and confirm confidence through discussions with experts, peers, and colleagues.


Vanaf 25 mei 2020 geldt de Medical Device Regulation (MDR). Vanaf deze datum moeten alle medische hulpmiddelen die in Europa op de markt worden gebracht aan de MDR voldoen. Deze interactieve workshop is bedoeld om innovators te informeren over de stappen die genomen moeten worden bij de implementatie van de nieuwe regels.

Onderwerpen die deze sessie aan de orde zullen komen zijn:

  • Het laatste nieuws rond MDR
  • Strengere eisen aan Notified Bodies
  • Klinische evaluatie
  • Klinische studies
  • Post Market Clinical Follow-up (PMCF)
  • Patiënten en zorgprofessionals krijgen toegang tot een Europese databank met informatie over medische hulpmiddelen op de Europese markt (EUDAMED)
  • Post Market Surveillance (PMS)

Speakers
Maroeska Rovers

Professor of Evidence-Based Surgery
Radboud university medical centre

Peter Reijntjes

Principal Consultant Regulatory & Quality Affairs
Qserve Consultancy

Main Event Partners

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