Transcription of Notified Body Position Paper
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Notified Body Position Paper
TEAM-NB Ref. Page 1/4 Adoption date : December 15th, 2021 Version The European Association Medical Devices - Notified Bodies Notified Body Position Paper Notified Body Position Paper on MDR/IVDR Implementation The purpose of this Position Paper is to address concerns of MDR/IVDR designated Notified Bodies in relation to MDR/IVDR Implementation respectively from 26th May 2021 or 26 May 2022 to 26th May 2024. 1. EXECUTIVE SUMMARY Team NB appreciates the Commission s efforts to implement the new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). These two new EU Regulations aim to improve patient safety by strengthening requirements for Manufacturers and Notified Bodies. 2. BACKGROUND With an increased demand for medical devices and given that AIMDD/MDD/IVD certificates will cease to exist in 2022, 2023 and 2024, there is a concern from Notified Bodies that there will be a potential risk of shortage of medical devices/IVDs for patients in Europe.
application resulted in the extension of a high number of MDD certificates and delay in the submissions of MDR applications from manufacturers. Furthermore, only 24 NBs are currently designated for MDR and only 6 for IVDR versus 51 for the MDD and 21 for the AIMDD /IVDD. MDR Transition period was compressed by 1 year and initiation of MDR Audits is
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