MDR – 4-year transitional period for certain Class I devices
The EU Parliament officially accepted the 2nd MDR corrigendum. As no request for a vote had been made on Tuesday 17 December, the text was deemed adopted. This concerns Class I products that were self-certified under MDD but now need Notified Body certification under MDR. Hence, the following Class I products that obtained MDD declaration of conformity prior to May 26, 2020 will get a 4-year transitional period until 2024: – Reusable surgical Instruments (scissors, forceps, scalpels,…) – Devices containing nano materials (e.g. dental impression material,…) – Software (e.g. dental imaging,…) – Substance-based devices (saline solutions for nasal cleaning,…). Link.
NOTE: these devices can benefit from the grace period only if following points apply: – No significant changes in design – No significant change in the intended purpose – Must follow MDR post-market surveillance (PMS), vigilance & registration Link to the approved corrigenda: Link.