This presentation considered the scope of MDR and IVDR regulations on innovation.
The new EU medical devices regulations have led to considerable changes affecting all the relevant stakeholders including device manufacturers, national competent authorities and notified bodies.
The aspirations of (EU) 2017/745 Medical Devices Regulation and (EU) 2017/746 In Vitro Diagnostic Regulation are widely considered to be valid and positive steps to regulate the industry due to the several high-profile public safety incidences.1
Nevertheless, there have been unintended consequences for industry which are likely to have an impact on innovation and route to EU market for existing and new healthcare products.
The original transition periods of 3 and 5 years for MDR and IVDR respectively were not sufficient, and further delays and postponements for implementation have been required because the infrastructure needed to meet the initial timelines was not adequate.
Despite the delays and postponements, however, problems continue.
Perhaps most concerning for industry is the limited capacity of notified bodies, which do not have the resources required to meet both existing and new product accreditation and certification. The problem with notified bodies is twofold: not only are fewer available but under the MDR/IVDR their workload has increased.
Notably, stricter regulatory requirements mean more detailed technical files for notified bodies to review, resulting in longer and unpredictable timeframes for approval. The current shortage of resources at the notified bodies inevitably is having a detrimental impact on all device manufacturers, particularly small and medium-sized enterprises. That is because with limited capacity and an increased workload, notified bodies have been reluctant to take on new business.
Current projections for notified body approvals do not provide the necessary assurance to support industry and patient application requirements. 2
For manufacturers another issue affecting route to market is the significant workload and time involved in achieving Quality Management System certification and the required product certifications. Many smaller businesses do not have the resources or the expertise to navigate the new pathways, with many unaware of the detailed requirements for the qualification of notified bodies or the need in some instances to find a new notified body.
As there is already such a backlog of existing products in the marketplace that will need to be certified under the MDR/IVDR, this inevitably means further delays in new and innovative products getting through the process. These problems have led some manufacturers to reduce their product portfolios, and for new product development projects to be put on hold.
The outcome of these issues is that the EU may now not the primary target market for launching new devices.3 The US system is well developed, established and understood. The FDA has worked with industry over the years to have a transparent, interactive approval process allowing for direct interaction with regulators via the Q-Submission process.
A serious concern for the EU market is not being able to maintain the current level of quality health care products on the market while also missing out on new innovative products as companies consider going to other markets first.
Summary take outs
• Significant changes to MDR and IVDR have had an impact on the regulatory pathway for CE marking and there may be unintended consequences for the EU market regarding innovation
• Notified body capacity is not sufficient to meet industry requirements, and this is leading to delays in product review and approvals
• Portfolio reduction has been common across industry due to the regulatory changes, and this will have an impact on EU patient access to the best and most suitable healthcare solutions
• Small and Medium sized Enterprises (SMEs) may be more adversely impacted due to not being able to access notified bodies and the increased resources and timelines for product approvals
• Design and development processes must adjust to the increased testing requirements and market approval process and this will have an impact on timelines, resources, and cost.
1. Implant scandal sparks EU medical device rule revamp
Health news September 26, 2012
Reuters – The EU said it wants tougher rules governing the safety and monitoring of medical devices after weak EU regulations were partly blamed for a global scandal over French made breast implants
2. Notified bodies overview approvals process – EU commission
3. MedTech Europe Survey Report analysing the availability of Medical Devices in 2022 in connection to the Medical Device Regulation (MDR) implementation July 2022