The EU had planned to implement a new set of regulations – the European Union Medical Device Regulations (EU MDR) in May 2021 and In Vitro Diagnostic Regulations (IVDR) in May 2022 – to establish stringent device controls, improve transparency and product traceability, and strengthen clinical evaluation and post-market surveillance. But a series of overwhelming events has forced EU regulators to shift the MDR implementation from May 2020 to May 2021.
The global COVID-19 pandemic is the primary cause of this deferment. However, constant pushbacks from trade associations have also played a role, as has strong evidence of the industry’s under-preparedness to comply. For example:
- Under the existing Medical Device Directive (MDD) there are 58 Notified Bodies (NBs) –organizations that have been designated by a member state to assess the conformity of certain products before being placed on the EU market – that cater to the industry. With the new regulations, there will be only 11 NBs with an EU MDR designation and three with an IVDR designation to handle a workload of 500,000 medical device technologies available in the European market
- Reclassification and up-classification of both existing and new products under the new regulations put considerable financial and administrative strain on small and mid-sized firms
- Increased complexity in documenting the additional requirements of clinical evaluation and post-marketing surveillance, as the industry moves toward a lifecycle approach, to necessitate proactive monitoring of device performance.
To overcome these challenges, stakeholders across the medical device industry, including medical device manufacturers, contract research organizations (CROs), and service providers, should focus on specific areas.
- Medical device manufacturers should outline a compliance strategy to adapt to the regulatory reforms. As the regulations also increase the cost and time required to enter the European market, they should also build alternative business plans, with a focus on budgeting resources and redefining product portfolio and market entry strategies to remain competitive. To achieve compliance and build a collaborative and transparent framework, they should also update their legacy systems and embrace cloud-based solutions
- CROs and service providers can provide strategic support to medical device manufacturers in building a regulatory roadmap and enhancing technological capabilities. Also, the new regulations’ stringent data requirements will increase the focus on data collection and management tools, and data governance and security. Service providers should align their clinical and post-market offerings with EU MDR and IVDR offerings to gain traction. For instance, HCL’s regulatory Center of Excellence (CoE) now provides end-to-end MDR and IVDR compliance services to manufacturers.
The medical device industry is exploring multiple ways to continue to stay relevant in the European market. While some organizations are leveraging the EU MDR and IVDR transitional provisions (MDD and IVDR certificates issued before May 2017, which will remain valid until they expire or May 2024, whichever comes earlier) to extend their market presence, others are building their regulatory capabilities and deploying both internal and external workforces to do so. Cook Medical, for instance, is hiring 20 full-time EU MDR-specific roles and working with over 70 contract-based individuals. Likewise, service providers such as Capgemini and TCS are seeking to hire regulatory specialists.
The launch date’s extension by a year might just provide the much-needed relief and time all stakeholders need to build their capabilities to comply with the new regulations.
For more insights on the impact of EU MDR and IVDR on the medical device industry, please see our recently published viewpoint Regulatory Overhaul of the EU Medical Device Market or contact [email protected], [email protected], or [email protected].