We have updated our Medical Device and In Vitro Diagnostic classification chart due to the huge success of the previous version. Have a look at the chart and feel free to ask us if you have additional questions.
Various drafts of the Medical Device Regulation and the In Vitro Diagnostics Regulation have been published back in 2016, already giving indications into which direction the regulations would evolve, upgrade the requirements compared to the respective directive and their effect on the technical documentation and thus the medical device manufacturers.
Recently, on May 5, 2017, the final text of the European Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) have been published in the Official Journal of the European Union. Consequently, both regulations come into force on May 26, 2017. Three years later, the application for the MDR will take place on the date of May 26,
The MDR will combine the Active Implantable Medical Devices Directive (90/385/EEC -- AIMD) and the Medical Devices Directive (93/42/EEC -- MDD) into one regulation. The IVDR will replace the In-Vitro Diagnostic Medical Devices Directive (89/79/EC -- IVDD).
The update of the tech documentation will start with the verification of the classification of your medical device or in-vitro diagnostic. Compared to draft publications of the regulations, the classification rules have been further upgraded with respect to numbering.
To assist you in your efforts to classify your IVD or Medical Device we have put together the criteria according to these novel regulations in an updated flowchart.
Contact: Marc Klinkhamer - Principal Consultant