Transitioning to the MDR

AESGP has remained vocal and contributed actively to the regulatory discussions within the Medical Devices Coordination Group (MDCG), highlighting the need to address major challenges in the overall implementation of the MDR in view of expected certification bottlenecks by the end of the transition period in May 2024. 

Transitioning to the MDR

In doing so and in close coordination with other industry associations, AESGP proposed certain measures to help increase the efficiency of the MDR system, including calls for:

  • proportionate timelines for implementing MDCG documents without affecting ongoing reviews/audits and pragmatic interpretation of MDCG guidance documents.
  • more dialogue between notified bodies and applicants before and during the certification process.
  • particular attention to the needs of SMEs facing delays in their formal application submissions, despite the review of technical documentation since the adoption of the MDR in 2017, due to a lack of notified bodies’ availabilities and capacities.

Consequently, AESGP welcomed the adoption of the MDCG position paper on notified body capacity and availability of medical devices and IVDs in August 2022 which lists different actions to address the significant and urgent challenges with a view to ensuring sufficient capacity of notified bodies and readiness of manufacturers in order to guarantee the transition from the Directives to the Regulations within the established transition periods. 

At the same time, AESGP worked to prepare the ground for the consideration of legislative measures by relevant actors to avoid shortages of medical devices and to ensure continued access to safe medical devices for patients, in cases where the non-legislative measures listed in the MDCG position paper do not deliver immediately. AESGP welcomed and supported the Commission’s announcement in December 2022 that a legislative proposal amending the transitional provisions of the MDR would be presented in January 2023.

Transitioning to the MDR

Data on self-care medical devices

AESGP launched a working process with IQVIA to explore possible methodologies and sources of reference for the identification of self-care medical devices in the IQVIA database to use such information, where appropriate, for commercial and advocacy purposes. In particular, the data derived pertaining to the self-care medical devices market in terms of value and volume would cover the European market and certain individual European countries.

Transitioning to the MDR

AESGP activities in relation to the MDCG Borderline Guidance

As part of its activities within the MDCG Working Group on Borderline and Classification, AESGP focused its efforts in particular on the development of the MDCG Borderline Guidance that was published in April 2022. In this context, AESGP highlighted the need for pragmatic, proportionate and workable MDCG Guidance on Borderline between Medical Devices and Medicinal Products to establish a balanced demarcation between these two product categories and to ultimately ensure continued access to safe and effective devices (see also AESGP’s statement on MDCG Borderline Guidance). Following its publication, AESGP stressed that any remaining uncertainties and challenges on specific aspects of the MDCG Borderline Guidance need to be addressed through a coordinated implementation process between manufacturers, notified bodies and competent authorities. Against this background, AESGP monitored the implementation of the Guidance closely to be ready to provide input to the discussion on the subject between all involved actors, where necessary.

In January 2022, AESGP also published an article that explores the challenges and uncertainties governing the consistent and pragmatic implementation of the MDR with regard to substance-based medical devices products. It gives an overview of the most prominent changes introduced under the MDR for substance-based medical devices regarding classification and safety aspects, as well as the relevant criteria for the demarcation between substance-based medical devices and medicinal products (see also AESGP’s statement in relation to this published article).