From MDD to EU MDR

Conducted by: Mr. Robert Van Boxtel
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The aim of this course is to inform the participants about the impact of the new European Medical Device Regulation that has entered into force per May 26, 2017. During the training, the new requirements will be discussed in detail and where possible will provide answers on how to implement the changes. The first day will focus on the revised...Continue reading

The aim of this course is to inform the participants about the impact of the new European Medical Device Regulation that has entered into force per May 26, 2017. During the training, the new requirements will be discussed in detail and where possible will provide answers on how to implement the changes.

The first day will focus on the revised scope of the Regulation compared to the Directive, the timelines of the transitional three years (and beyond), identify the requirements for the Economic Operators as defined by the EU MDR (including Person Responsible for Regulatory Compliance) and discusses impacts for Health institutes in the European Union.

On the second day, the revised classification rules and conformity assessment routes are discussed and compared to the current requirements, resulting in a clear overview of actions to be taken regarding compliance with revised QMS, Technical dossier and PMS requirements.

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Dates: 
  • 12/11/2019
  • 13/11/2019
Course location: Kfar Maccabiah, Ramat Gan
Duration: 2-Days Course
Hours: 09:00 - 17:00
Credits: 2
Course Language: English

Course price: ₪5,850 Including VAT
Early registration is Closed
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Issues to be covered

Day 1:

  • Introduction to the new MDR – why was a revision needed? Timelines – transition periods – validity of certificates – Status of Notified Bodies.
  • Scope of the MDR (Article 1) – What products are covered and which not.
  • New/revised important definitions (Article 2) and Eudamed – what is it, what do you need to do as manufacturer.
  • Economic Operators: Manufacturer, Authorized Representative, Importer and Distributor (M.A.I.D.) – their roles, rights and responsibilities and what actions do you need to take as manufacturer towards them.
  • Impact for Health Institutes in the EU – challenges regarding “home brew” devices made by hospitals and reprocessing of single use devices.

Day 2:

  • Classification and Conformity Assessment routes – what has changed and how will it impact you as manufacturer
  • QMS requirements – including comparison to ISO 13485:2016
  • Annex I: General Safety and Performance Requirements  many more requirements are written down. But how new are they? Including label and IFU requirements.
  • Annex II: Technical Documentation requirements: How to present the technical documentation to the authorities (incl. Notified Bodies), including Clinical evaluation and PMCF requirements – how to keep it practical (is that still possible?).
  • Post Market Surveillance: Planning, executing and reporting, including adjusted vigilance and FSCA requirements.

Who should attend

This course will be extremely useful for the persons working in regulatory and quality assurance departments, and equally important for project managers or CTO’s involved in development of new medical devices. Last but not least, as CEO of a medical device company, you will obtain a clear insight in the new EU requirements and the impact it will have on your business case or company.

Benefits to the Participants

At the end of the seminar, you will be able to draft your company’s action plan, enabling working towards EU MDR compliance throughout the lifecycle of a medical device.

About The Lecturer

Robert Van Boxtel
Robert van Boxtel has over 20 years of experience in
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