Although 2021 has only just begun, manufacturers of in-vitro diagnostics must already look to 2022, when the current IVD directive will be replaced by an EU-wide regulation.
On May 26, 2022, the five-year transitional period to replace the currently valid IVD Directive (98/79/EG) expires and the European Regulation for In Vitro Diagnostics (IVDR; 2017/746) is mandatory in the European Union. This regulation sets out rules for placing on the market, making available on the market and putting into service in the EU in vitro diagnostic medical devices and their accessories intended for human use. The aim is to set higher standards for the quality and safety of IVD products and to increase health protection for patients, users and third parties.
This also means that companies’ technical documentation (TD) must be much more detailed than before, it must be “presented in a clear, organized, easily searchable and unambiguous form”. All details of the TS and the information to be provided are regulated in Annexes II and III of the regulation and show broad agreement with the requirements of the TS for medical devices.
In the area of sample documentation, we and our partner MEDEORA help companies to implement this regulation in compliance with their biobank software and services. “We provide our customers with the software tools and service together with LIMs at work. In this way, the entry into force of the regulation can be met with ease,” explains Dr. Norbert Schmeisser, Managing Director MEDEORA GmbH.