MDR is Here
On 26 May 2021, the Medical Devices Regulation (EU) 2017/745, more commonly known as MDR, became applicable (see AESGP’s statement on the Medical Devices Regulation’s date of application) after being postponed for a year due to the COVID-19 outbreak. The date of application represented a very important milestone, but certainly did not mark the end of the MDR implementation process for the medical device sector in general and the self-care medical device sector in particular. The latter of which is represented by AESGP and includes substance-based medical devices.
Horizontal challenges in the MDR implementation process
AESGP has remained vocal in Medical Devices Coordination Group (MDCG) meetings with stakeholders by addressing horizontal challenges and uncertainties in the ongoing MDR implementation process directly to MDCG members (i.e. national competent authorities), such as:
- Certification bottlenecks expected at the end of the transition period in May 2024, jeopardising the timely certification of these devices under the MDR.
- The need for a pragmatic approach to implementing the MDCG Guidelines to ensure predictability and certainty for stakeholders throughout the certification process.
- The need to accept remote audits under the MDR by all Member States to ensure harmonisation and avoid bottlenecks for MDR certification processes.
Considering the horizontal challenges, AESGP further coordinated and made numerous contributions to the 10 MDCG subgroups in which AESGP is represented (Borderline & Classification (B&C); Clinical Investigation and Evaluation (CIE); New Technologies; Unique Device Identification (UDI); International matters; Post-market Surveillance and Vigilance (PMSV); Standards; Nomenclature; Annex XVI; Eudamed), particularly in relation to the development of MDCG guidance documents.
AESGP activities in relation to the MDCG Subgroup on Borderline & Classification
AESGP activities have focused in particular on the work of the Borderline & Classification Subgroup and its efforts to develop an MDCG guidance on the borderline between medical devices and medicinal products.
As one of its main priorities, AESGP has highlighted the importance of an appropriate and proportionate implementation of the recognition of substance-based medical devices by the MDR through this guidance. In the same context, AESGP pointed out that a disproportionate interpretation of an ancillary substance under Classification Rule 14, which has been slightly reformulated in the MDR, should be avoided. Consequently, AESGP has been calling for a balanced demarcation between the different regulatory frameworks, in particular between the Medical Devices Regulation (MDR) and the Medicinal Products Directive (MPD). In furtherance of these objectives, AESGP presented the industry perspectives on a regulatory framework suited to the needs of substance-based medical devices at the European Parliament’s Panel for the Future of Science and Technology.