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MDR/IVDR Corrigenda 2 receives EP consent

  • Posted by: inetika
  • Category: GLOBAL NEWS

The second corrigenda to the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) have now been approved by the European Parliament and Council of the EU, confirming clearances in the ENVI and EPSCO committees. This means that now under the MDR, certain devices have been granted additional time for demonstration of compliance.

Although the corrigenda are not yet available on the Commission’s medical devices website, it is understood that they are unchanged from the MDR and IVDR documents made available by the Commission at the end of November (see previous news item).

According to the corrigendum for the MDR, the devices that will be able to benefit from the additional time extension are those that are class I according to Directive 93/42/EEC (MDD), for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to the MDR requires the involvement of a notified body. These devices may now continue to be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 they continue to comply with MDD, and provided there are no significant changes in the design and intended purpose.