A futuristic study on in-vitro medical devices regulations

Abstract

The In-Vitro Medical Devices Directive (IVDD) established in 1998 by the European Union met the requirements of the single medical device market. In the due course, IVDD could not regulate all new technical and medical developments in the sector. The IVDD 98/79/EC, was preceded with IVDR 2017//746; which defined and demonstrated conformity to essential requirements, established harmonized standards and facilitated the organization of ‘Notified Body’ (NB), Competent Authority oversight and market surveillance. IVDR implemented streamlines as defined in Annex I of the EU IVDR 2017/746 conforming to the relationships between the performance requirements and general safety, and Annex I of the EU Directive 98/79/EC for IVDD for the essential requirements. The importance of the Unique Device Identification and its implementation in the safety and conformity of the device was made stringent for the manufacturers. The recent developments in IVDR, with reference to EUDAMED database, enable the applicant for accessing of data entered for the revival, correction and the assessing of information.