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MDR Master ClassThe latest update information on implementation of the MDR (EU Regulation 2017/745)

Conducted by: Mr. Robert Van Boxtel, Mr. Vincent van der Meer
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Due to the Covid-19 pandemic, the EU Commission has decreed that the date of application of the MDR was postponed with one year till May 26, 2021. In practice this means that the MDD and AIMDD remain valid for another year. However, the “soft transition period” after May 26, 2021 till May 26, 2024 is not extended. So, do not...Continue reading

Due to the Covid-19 pandemic, the EU Commission has decreed that the date of application of the MDR was postponed with one year till May 26, 2021.
In practice this means that the MDD and AIMDD remain valid for another year. However, the “soft transition period” after May 26, 2021 till May 26, 2024 is not extended.

So, do not sit back and relax! Work towards meeting MDR requirements.

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Dates: 
  • 07/06/2022
  • 08/06/2022
  • 13/06/2022
  • 15/06/2022
Course location: Zoom Course
Duration: 4 meetings 1.5 hour each
Hours: 17:00 - 18:30
Credits: 1
Course Language: English

Course price: ₪1,800 + VAT
Early registration is Closed
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Issues to be covered

  • Day 1: Update on latest news from Brussels (Commission MDR Rolling plan status, Update on NB designations, Status of MDCG guidance development, Discussion on content of some latest MDCG guidances)
  • Day 2: QMS and TD requirements: Article 10+Annex IX vs EN ISO 13485; Technical dossier requirements; Discussion on findings made during audit and TD review.
  • Day 3: Eudamed – Available modules – live demonstration of Eudamed through playground environment. If time allows – latest in UDI.
  • Day 4: Clinical evaluation, PMS and PMCF

Who should attend

Specifically PRRCS will benefit from the information provided
This Master Class is not suitable for beginners, as it will not discuss the fundamentals of the MD

About The Lecturer

Robert Van Boxtel
Robert van Boxtel has over 20 years of experience in
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Vincent van der Meer
Studied life sciences (molecular biology) in Leiden, The Netherlands. Started
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