Masterclass Medical Device Regulation (MDR)

500 Exclusive of VAT

The MDR will come into effect on May 26, 2021 and will mean that more devices will be qualified as medical devices. In addition, existing medical devices are often faced with stricter requirements as a result of the changes in the risk classes. This masterclass aims to give manufacturers of software in particular tools to achieve compliance with the MDR.

After registration you will have direct access to the online module in your training portal. Here you can also register for multiple modules of your choice.

Category:

On May 26, 2017, the European Regulations on Medical Devices (MDR) and In Vitro Diagnostic Devices (IVDR) entered into force. The MDR will apply on May 26, 2021 and the IVDR on May 26, 2022. These regulations extend the current legislation and regulations with the aim of further protection of the European citizen. One of these extensions concerns the qualification of medical devices. For example, under the MDR, software will sooner be classified as a medical device than is currently the case.

If you are a manufacturer or importer of medical devices, or if you are otherwise dealing with them, it is advisable to obtain information in advance and make the necessary preparations for the MDR.

First Lawyersorganizes a master class in which the most important aspects, rights and obligations, and consequences for your business operations are discussed. In doing so, we pay attention to, among other things, the parties that are addressed by the regulations, the requirements set by the regulations and we specifically address the question in which cases software should be regarded as a medical device.

After the masterclass, you will know what the consequences of the MDR are for daily practice and what preparations are required to comply with the MDR on 26 May 2021. During the meeting and after the conclusion, there is of course the opportunity to ask questions.

First Lawyers attorneys can provide legal support in preparing to be demonstrably compliant and accountable, click here for more information.

Content

  • Overview of laws and regulations regarding medical devices;
  • Classification of medical devices according to the MDR;
  • Software as a medical device;
  • Obligations of the MDR for market participants;
  • Requirements of the MDR for market authorization;
  • Stakeholders at the MDR; and
  • Medical devices and COVID-19.

Workshop

After registration you will have direct access to the masterclass in the training portal of Duthler Academy. Here you can register for the (online) masterclass.

(Online) Start:

  • March 25, 2021;
  • April 15, 2021;
  • July 2, 2021; and
  • October 13, 2021.

Costs

The total costs for the module are € 500 (excluding VAT and per person).

Duthler Academy works with several platforms:

Private individuals and government institutions are exempt from VAT.