Online Workshop

The workshop and materials will be in the English language.

What are in vitro diagnostic (IVD) medical devices?

 IVD medical devices are tests used on biological samples (such as tissue, blood, or urine) to determine a person’s health. There is a very wide range of IVD medical devices, from pregnancy self-testing aids, blood glucose meters to HIV tests, blood group tests and various types of cancer tests. Unlike medical devices or IVD pharmaceuticals, medical devices never come into contact with a person and do not treat patients but provide information about the functioning of the body. IVD medical devices do not cause direct harm, but they pose a very high risk if their use leads to misdiagnosis. A detailed definition of IVD medical devices is given in Regulation (EU) 2017/746, Article 2.

This year, completely new rules will apply to manufacturers and other economic operators (authorized representatives, importers, distributors) who want to put their in vitro diagnostic medical devices into use and make them available on the market – the long-awaited Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on In Vitro Diagnostic Medical Devices or IVDRs for short. After a five-year transition period, the IVDR will replace the IVDD (In Vitro Diagnostic Medical Devices Directive 98/79 / EC) on 26 May 2022 and will apply in all EU Member States and EFTA countries.

This means that economic operators wishing to receive the CE mark for their products or to market their products in Europe will encounter a new set of requirements that are generally stricter, more demanding, more complex, and time-consuming than those currently required to comply with. With the IVDR, the European Commission wants to create a solid, transparent, sustainable, and internationally recognized regulatory framework that will improve the clinical safety, quality and reliability of IVD medical devices and ensure fair market access for manufacturers, healthcare professionals and end-users.

Purpose

At the seminar, we will present the new requirements of Regulation (EU) 2017/746 which are important for manufacturers, authorized representatives, importers and distributors of in vitro diagnostic medical devices in the European Union, and for professionals involved in quality management systems, including IVD medical devices.

Content

• Overview of Regulation (EU) 2017/746 and definitions
• Obligations of economic operators
• Classification and conformity assessment
• Safety and efficacy requirements (Annex I – GSPR)
• Requirements for technical documentation
• Unique Identification System (UDI) and EUDAMED
• Post-market surveillance and vigilance

Lecturer Marjeta Tušek Jelenc is a university graduate in physics. She began her professional career as a researcher at the Medical University of Vienna, where she was involved in the development of a new magnetic resonance method. In 2017, she joined SIQ Ljubljana as a professional associate in the field of medical device certification. Since April 2021, he has been employed by the Swiss company Smart Blood Analytics Swiss SA, where they develop software for in vitro diagnostic medical devices and is responsible for their compliance with relevant legislation. She is a SIQ auditor for ISO 9001, ISO 13485 and MDR.