In Vitro Diagnostic Regulation (IVDR)

As manufacturer of IVD products, VIDIA spol. s r.o. decided to use the rules for legacy devices according to Article 110 IVDR (2017/746), Transitional provisions cited below and concerns all IVD products stated in Declaration of conformity issued by VIDIA spol. s r.o.:

„3) By way of declaration from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 98/79/EC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with that Directive, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply and replace the corresponding requirements in the Directive.“