The Medical Device Coordination Group (MDCG) has issued a new revision of its notice to manufacturers and notified bodies to ensure they timely comply with MDR and IVDR requirements. In this position paper, the MDCG acknowledges the effort of manufacturers who already meet MDR/IVDR requirements. Nevertheless, the latest Notified Bodies survey shows that MDR and IVDR applications remain low.
Due to this, the MDCG urges manufacturers to transition to the Regulations as soon as possible and ensure timely submissions, otherwise this could lead to bottlenecks for notified bodies. This is particularly relevant for manufacturers of Class D IVD devices, which must transition to IVDR by May 2025.
On the other hand, notified bodies are encouraged to consider SMEs’ interests about fees and improve their conformity assessment activities in terms of transparency, timelines, predictability, and consistency.
To streamline the certification process, notified bodies must provide proper assistance to manufacturers through structured dialogues that must not be considered as a separate service but part of the pre-application and conformity assessment activities.
Finally, both manufacturers and notified bodies are requested to provide data regularly regarding the certification of devices.
Furthermore, with this very purpose, the Italian Ministry of Health has released a notice for Italian MDR manufacturers encouraging them to submit a notification to a notified body well before 26 May 2024 deadline and to have a contract signed with a notified body on the conformity assessment of their devices by 26 September 2024.
You can find more of these and other relevant documents in our MDlaw Library of documents.