The team of KIELTYKA GLADKOWSKI dedicated to clients operating in life science sector actively advises on all aspects of in vitro diagnostics, including regulatory, corporate and investments matters. For the purposes of such clients this text analyses the bullet points of REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Regulation 2017/746/EU (IVDR) replaces the existing Directive 98/79 / EC on in vitro diagnostic medical devices (IVDD), which was adopted in 1998.
With the publication of the IVDR, the five-year transition period from the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD) to the new regulation has started. The IVDR regulation will apply from the date of application, i.e. from May 26, 2022, with some provisions, including Notified Bodies and the Medical Device Coordination Group will enter into force sooner. Until the date of application of the IVDR, the laws and regulations adopted by the Member States under the IVDD will continue to apply. Under Art. 22 of the 1998 IVDD directive, the member states were obliged to prepare and introduce the national laws, regulations and administrative provisions necessary to comply with this directive by December 7, 1999 (IVDD) at the latest. The provisions of the directive were to apply with effect from 7 June 2000. As the provisions of the directive could be interpreted differently in different countries, it was possible for national provisions to differ. In the case of EU regulations, the provisions contained therein do not have to be transposed and adapted to national law. In May 2017, the European Parliament and the Council of the European Union published two new regulations on medical devices (2017/745/EU) (MDR) and in vitro diagnostic medical devices (2017/746/EU) (IVDR). Regulation 2017/746/EU (IVDR) replaces the existing Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), which was adopted in 1998.