Five years have passed since the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). Gradually, the transition period that allows manufacturers to prepare to certify medical devices and in vitro diagnostic medical devices in accordance with MDR and IVDR comes to an end. From 27 May 2024, the MDR will be fully applicable to all medical devices.
In August 2022, Medical Device Coordination Group (MDCG) published a guidance document (MDCG 2022-14) for notified bodies and manufacturers where they propose actions to facilitate a transition to the MDR and IVDR and to avoid a shortage of medical devices.
The most important actions MDCG wrote down that encourage the notified bodies to start implementing are listed below:
- The use of hybrid audits will contribute to conducting the conformity assessment in a timely and efficient manner.
- To avoid unnecessary duplication of work, MDCG encourages notified bodies to develop a framework for leveraging evidence from previous assessments conducted with regard to requirements under the old Directives.
- The development of Eudamed should ensure that notified bodies can upload relevant information machine-to-machine. This will avoid double registrations.
- Notified bodies should rationalize and streamline internal administrative procedures and ensure that proper conformity assessments are carried out in a timely and efficient manner.
- Training, coaching and internship activities for personnel of existing and potential new notified bodies should be fostered.
- Modification of frequency of complete re-assessment of notified bodies is suggested. It is proposed to defer a complete reassessment to up to 5 years after notification.
- MDCG calls upon all parties involved in the assessment, designation, and notification of conformity assessment bodies to make all efforts to speed up this process while preserving the level of requirements to be met by notified bodies under the Regulation.
The most important actions that encourage the manufacturers to start implementing are listed below:
- The MDCG reminds manufacturers to ensure timely compliance with MDR requirements.
- The MDGC encourages manufacturers as well as notified bodies to organize structured dialogues before and during the conformity assessment process.
- The MDCG calls on all parties involved to step up communication with manufacturers by means of webinars, workshops, targeted feedback, and informative sessions.
Some data show that more than 90% of currently valid MDD/AIMDD certificates will expire in 2023-2024. This will burden the notified body capacity to evaluate submitted applications. Therefore, and in order to ensure that devices can continue to be placed on the market and to avoid shortages of medical devices, it is essential that all manufacturers adjust their system, finalize transition to the MDR and apply to a notified body, submitting complete and compliant applications, as soon as possible and well in advance of the end of the transition period to ensure timely compliance with the MDR.
The MDCG list of actions will help to avoid shortages of medical devices on the market with enhancing notified body capacity and accessing to notified bodies and manufacturers’ preparedness.