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Reminder for in vitro diagnostic medical device sector: IVDR is now fully applicable

Transition period for the use of the In Vitro Diagnostic Regulation 2017/746 (IVDR) came to an end, hence as of 26th of May its provisions are mandatory to be followed by all in vitro diagnostic medical device sector.

IVDR came into force on May 25, 2017, repealing the Directive 98/79/EC. This new legislation covers in vitro diagnostic medical devices, which are defined as any reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, pieces of equipment, software, or systems, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information. The IVDR is intended to ensure a higher level of public health and patient safety, by considering scientific progress, and to ensure a smooth operation of the single market for these products. You can also find more information regarding the new legislation on the EC’s website.

If you market in vitro medical devices of Swiss manufacturers, be aware that the EU-Switzerland Mutual Recognition Agreement (MRA) was not updated in line with the new EU legislation. Therefore, with the mandatory use of the IVDR, the seamless trade of in vitro diagnostic medical devices between Switzerland and EU is not possible anymore. Swiss manufacturers are treated as any other third country manufacturer intending to place its devices on the EU market. You can find more information here.

Implementation of all changes that were introduced with the IVDR, including required reclassifications, labelling and post-market surveillance activities, can mean a lot of burden for business operators, therefore Billev Pharma East team is here to help you with any regulatory, quality or vigilance challenges that you might be facing.

 

MDCG publishes Guidance on transitional provision of IVDR 

As stated above on 26th of May 2022, the European IVD Regulation (EU) 2017/746 (In vitro Device Regulation) has entered into force. This will be accompanied by various transitional periods and requirements, which have been summarized and explained by the Medical Device Coordination Group (MDCG) in a new guidance document Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (MDCG 2022-6). Document is aimed at manufacturers who have so far complied with the requirements of Directive 98/79/EC and may continue to market their in vitro diagnostic devices in accordance with this Directive during the transitional periods.

The medical devices discussed therein must hold:

  • a valid certificate issued by a notified body in accordance with Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), and;
  • a declaration of conformity issued prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure under the IVDR (contrary to the IVDD) requires the involvement of a notified body.

A further requirement is that during the transition period no significant changes to the design or intended purpose have been made to devices placed on the market under the “old” Directive. With practical tools such as flowcharts for self-assessment and clarification of questions on product changes, the guideline offers a clear compilation on this topic and shows in detail which changes are to be assessed as significant and which are not.