The European Parliament has adopted a resolution calling for swift revision of both the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in response to “the most pressing challenges and bottlenecks”.
The European Parliament recently voted by a large majority to pass the resolution – entitled ‘Urgent need to revise the medical devices regulation’ – in a bid to avoid potential product shortages in the region, while also laying out a timeline for targeted changes.
In a joint motion, the Parliament asked the European Commission to propose “systematic revision” of the existing legislation and complete an impact assessment by the end of the first quarter of 2025.
Responding to the news, Head of Regulatory Affairs at formal NHS Scotland partner InnoScot Health, Elaine Gemmell said it represents “a very positive, timely step which helps to address urgent patient need and responds well to manufacturers’ concerns”.
Products certified to the EU MDR can be placed on the Great Britain market up until June 2030 depending on the device classification and certain criteria being met.
Medical device manufacturers have continued to express concerns about successfully meeting stipulated deadlines within the current demands of the MDR and IVDR, allowing them to transition their products in sufficient time.
The resolution states that challenges in implementation – primarily for SMEs – are resulting in delays and not being able to achieve certification and approval, with a knock-on effect for patients’ speed of access to vital technologies.
It notes that there is “a need for the regulatory frameworks to better accommodate innovative devices that address unmet medical needs and provide better prioritisation and fast-track pathways”.
Several Members of the European Parliament introduced the joint motion.
Warning that the situation could worsen, MEP Peter Liese said: “This is costing jobs and competitiveness – but most importantly, patients are suffering.”
The MEP further urged the European Commission to “massively accelerate” its process in order to successfully revise the laws.
Elaine commented: “InnoScot Health fully supports the resolution which has clearly become a significant priority amid concerns over a perceived lack of harmonised procedures across notified bodies in the EU.
“There have also been widespread reports of unpredictable timelines for manufacturers looking to swiftly make their products available without compromising patient safety, amongst other issues.
“For me, that is the real crux of the matter – placing a focus on addressing challenges in getting devices safely to patients – and it needs to be immediate, including establishing an accelerated pathway for breakthrough innovation.
“The resolution calls for better support for SMEs delivering innovative and life-saving medical technologies as part of a systematic revision of the current regulations.
“It also calls on the Commission to ensure unnecessary recertifications and that certain products are not required to undergo the entire recertification process – an essential aspect of speeding up MDR and IVDR processes.
“If these can be delivered alongside the resolution’s call for the establishment of a single, dedicated governance structure to oversee the regulatory system, then that is very welcome news for all.”
