Last November, the Medical Device Coordination Group (MDCG) approved the revision of the MDCG 2022-11, Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements guideline. Specifically, the ‘Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay‘ section has been modified. This change involves manufacturers who are encouraged to apply for EC certification following MDR or IVDR for their Medical Devices without further delay. Moreover, a new section ‘Call to notified bodies to streamline the certification process‘ has been added.
The MDCG recognises the efforts of the many manufacturers who have already adapted their Quality Management System to the European regulations. However, data provided by Notified Bodies in June 2023 show limited progress in terms of applications submitted and certificates issued. Compared to more than 24,000 certificates issued under Directives 90/385/EEC and 93/42/EEC, only about 13,000 MDR applications were submitted and about 3,900 certificates were issued. Moreover, about 1,000 of the latter are related to updates.
Consequently, manufacturers prefer to transfer devices to be included in the same certificate at different times. However, this approach could create problems in the planning and capacity of Notified Bodies. Moreover, their data show that most of the manufacturers’ applications are incomplete, causing further delays in the certification process.
Therefore, to improve the efficiency of the process and ensure a smooth transition, the MDCG urges manufacturers to make the most of the additional time allowed by Regulation 2023/607 by submitting conformity assessment applications in good time.
The MDCG also urges Notified Bodies in the guidelines to make the certification process more streamlined. Indeed, they must simplify their procedures and make all necessary efforts to improve their conformity assessment activities in terms of transparency, timing, predictability and consistency.
In conclusion, manufacturers are urged to intensify their efforts to make the transition as soon as possible and not to further delay the submission of applications, as this could lead to bottlenecks in the work of Notified Bodies and possible product failures on the market. It is precisely for these reasons that the Notified Bodies have strongly recommended submitting applications by the end of 2023. Notified Bodies for their part are called upon to adequately assist manufacturers with regulatory guidance and technical information on how to apply for conformity assessment procedures to speed up the certification process and avoid incomplete applications, which have been identified as one of the most important causes of delays.
>> Through the services of strategic-regulatory consulting, support for EC certification and if required, European Authorised Representative, Thema can provide support in the implementation of the requirements of the Medical Device Regulation MDR (EU) 2017/745 and the In Vitro Diagnostic Devices Regulation IVDR (EU) 2017/746.
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