With the regulatory changes facing the medical device industry, the European Union’s Medical Devices Coordination Group (MDCG) has published a position paper (MDCG 2022-11 Rev.1) aimed at ensuring that manufacturers and Notified Bodies are able to comply in a timely manner with the requirements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This document highlights the significant changes in the regulatory framework for medical devices and in-vitro diagnostic medical devices since the adoption of these two regulations in 2017, with the main objective of creating a robust, transparent, predictable and sustainable regulatory framework that ensures a high level of safety and health while supporting innovation.
Six years have passed since the implementation of the MDR and the IVDR, and the transitional provisions of the regulations have been revised to provide more time for manufacturers and notified bodies to carry out the necessary compliance assessment procedures to avoid the risk of device shortages in the EU healthcare system.The MDCG has made it a top priority to improve the capacity of the notified bodies and the efficiency of the compliance assessment process, and through the actions outlined in MDCG 2022-14 The MDCG has achieved good results through the actions listed in MDCG 2022-14, such as the use of hybrid audits, the postponement of the reassessment of Notified Bodies, and the clarification of the meaning of “persons employed by the Notified Body” in Article 36(1) of the MDR and Article 32(1) of the IVDR.
To date, 40 and 12 notified bodies have been designated under the MDR and IVDR, respectively. Despite the improved efficiency of the designation process for Notified Bodies, the number of applications submitted and certificates issued, based on June 2023 data, remains limited. Only about 13,000 MDR applications have been submitted and 3,900 certificates have been issued as compared to more than 24,000 certificates issued under the previous Directive. Of these MDR certificates, about 1,000 were related to renewals, indicating a tendency for manufacturers to move devices to the same certificate at different times. While this practice is understandable, it may pose problems for the planning and capacity of notified bodies. For IVDs, the situation is even more worrying. The proportion of IVDs that only require notified bodies to be involved in the compliance assessment is around 8% under IVDD, while under IVDR this proportion is around 80%. Nonetheless, as of June 2023, only 1,150 IVDR applications have been filed and about 500 certificates issued, compared to about 1,500 certificates issued under the IVDD.
The MDCG is calling on manufacturers to transition to the regulation as soon as possible and submit applications for certification immediately to avoid the risk that further delays could lead to bottlenecks in the work of notified bodies and product shortages in the market. In particular, manufacturers of Class D IVD devices must transition to the IVDR by May 2025.The notified body strongly recommends applying by the end of 2023. In addition, manufacturers should work closely with the authorities and the European Commission to increase transparency and improve the exchange of information on specific medical devices so that Member States and the European institutions have time to prepare for changes in the product range.
The MDCG also called on notified bodies to streamline the certification process to make it more efficient, transparent and predictable. Notified Bodies should streamline their processes and make every effort to improve their conformity assessment activities, particularly in terms of transparency, timelines, predictability and consistency. Notified bodies should operate on consistent, fair and reasonable terms and conditions, taking into account in particular the interests of SMEs in terms of costs.
In summary, this MDCG position paper emphasizes the critical role of manufacturers and notified bodies in the transition to the new regulations and provides a series of calls to action to ensure a smooth transition and continued growth of the medical device industry.