Medical devices (MD) and in vitro diagnostic medical devices (IVD) must be safe and suitable for the purpose they are intended. Therefore, they are highly regulated globally. Number of Loimu members are working with MD or IVD devices, either in their production, sales or inspection and control. For biotech professionals the understanding of the regulation is very useful.

In the European Union countries MDs and IVDs must be CE marked meaning that MDs must comply with the Regulation (EU) 2017/745 on medical devices and IVDs with the Regulation (EU) 2017/746 on in vitro diagnostic devices.

This training gives an overview of the requirements behind the CE marking of MDs and IVDs and how these devices can be placed on the European Union market. This training will introduce the principles how to qualify a device as a MD or IVD, how the device is classified, how the compliance to the Regulations is demonstrated and what are the responsibilities of different economic operators. In addition, actions needed during the lifecycle of a device are discussed.

Learning goals

• Get an overview of the European Union regulations for medical devices and in vitro diagnostic medical devices
• Understand how medical devices and in vitro diagnostic medical devices can be placed and kept on the market in European Union countries
• Understand the roles and responsibilities of operators during the lifecycle of medical devices and in vitro diagnostic medical devices

Target group

The training has been specifically tailored for Loimu members by Labquality and it is useful for members working or planning to work in industry with medical devices / in vitro diagnostic medical devices or in production or R&D of them. It is also useful for members interested in supervision of the analytical or clinical performance of devices e.g. through Fimea. 

It is good to understand the basics about quality management and ISO standards, but it is also possible to join the training without any experience in the area.

Note that there is basics training about quality management Getting familiar with ISO 9001 in 13th-14th of June.

Price: 150 € (discount price 75 € for unemployed, on family leave, on grant). Note: value of the training is 780 €.

Ask your employer, if they are willing to cover the expences and if you would be able to use your work time to participate the training. 

Trainer: Nina Vartiainen, Labquality

Schedule and organizing:
Training will contain two half day sessions (from 08:30 AM to 12 PM). See the details in "Program and content". 

Loimun GDPR statement for trainings: https://www.loimu.fi/en/privacy-policy/privacy-policy-for-events-and-training/