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.
The training has been specifically tailored for Loimu members by Labquality.
Content of the Online Training
Scope and definitions
- Scope of the MDR 2017/745 and products that fall within the definition of a medical device
- Scope of the IVDR 2017/746 and products that fall within the definition of an in vitro diagnostic medical device
- Who are they? What are their roles and responsibilities?
- A European authorized representative
- A distributor
- An importer
- A manufacturer
- A person responsible for regulatory compliance
Classification of medical devices under MDR and in vitro diagnostic medical devices under IVDR
- Intended purpose
- Qualification of medical device / in vitro diagnostic medical device
- Risk based classification
- Rules of medical device/ in vitro diagnostic medical device classification
Conformity assessment routes and the role of Notified Bodies
- Quality management system requirements and ISO 13485
- What is a Notified Body?
- Explanation of different conformity assessment routes
- CE marking
Key elements of technical documentation
- Device description and specification
- Information to be supplied by the manufacturer
- Design and manufacturing information
- General safety and performance requirements
- Benefit-risk analysis and risk management
- Product verification and validation
- Post-market surveillance
- MDR 2017/745: Clinical Evaluations
- Clinical performance
- Clinical investigations
- Post-market clinical follow-up
- IVDR 2017/746: Performance evaluations
- Scientific validity
- Analytical performance
- Clinical performance
- Performance studies
- Post-market performance follow-up
Post-market surveillance and vigilance
- Requirements after product launch e.g., information gathered by manufacturer in cooperation with other economic operators
- Reporting requirements of serious incidents and field safety corrective actions
- 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
Schedule: 22nd of March at 8.30 am -12.00 pm and 23rd of March at 8.30 am -12.00 pm.
Price: 200 € (100 € unemployed, grant, parental leave).
Trainer: Anja Kontio, Labquality
This training is continuation to the training ISO 13485:2016 -standardi tutuksi, but you can also join without that experience.
Loimu members especially in biotech branches.
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