The Medical Device Coordination Group (MDCG) has issued this June 2022, a position paper on the need for manufacturers to ensure timely compliance with MDR requirements. This document is intended for manufacturers of legacy devices, who will need to meet full MDR requirements at the end of the transition period. This will be at the moment of the expiry date of their MDD CE Certificates or on 26 May 2024, whatever is sooner. As of 27 May 2024, all medical devices to be placed on the EU market must comply with the Medical Devices Regulation 2017/745.
The MDCG points out that “more than 90% of currently valid AIMDD/MDD certificates will expire in 2023-2024”, indicating that many applications for an MDR CE Certificate have been deemed incomplete by notified bodies. As such, the document stresses to:
- Make use of the transitional period to prepare the quality management system (QMS) and technical documentation according to MDR requirements before applying to a Notified Body;
- Apply to a notified body, submitting complete and compliant applications at least one year before the expiry date of the MDD/AIMDD certificate;
Furthermore, the MDCG reminds manufacturers that “medical devices not certified under the MDR will have no access to the EU market” from 27 May 2024.
Additionally, the MDCG warns manufacturers seeking to be exempted from the conformity assessment procedure based on public health, patient safety or patient health criteria as per Article 59 MDR and other mechanisms (such as the ones stated in chapter VII MDR) to not rely on these alternatives. The derogation will only be possible if the manufacturer provides enough proof of its efforts to successfully conclude the transition to the MDR (including a submitted application to a Notified Body on time).
Adding to this document, the CAMD (Competent Authorities for Medical Devices) has also warned in a recent statement about the possibility that some manufacturers may not be compliant by May 2024.
To avoid the disruption of the supply of essential medical devices, the CAMD aims at close collaboration with all involved stakeholders to seek for all possible solutions. Similar to the MDCG, the CAMD considers derogations from conformity assessment to be applied only as an exception to the rule. In CAMD’s view, the MDCG and the collaboration with notified bodies and stakeholders should provide further solutions to the problem.
Do you wish to know more about existing timelines for MDR and IVDR? You can find these and other relevant guidances for your devices in our MDlaw Library.
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