There is an increasing clamour for a rethink of EU medical device regulation. This has gone as far as a Joint Motion for a Resolution from the EU Parliament, on the urgent need to revise the EU Medical Devices Regulation. The AI Act is in a large part inspired by, and follows the structure of, Regulation (EU) 2017/745 for general medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The EU Parliamentary Joint Motion notes that the MDR and IVDR represent "significant challenges" for stakeholders in implementation, leading to delays and a failures to achieve notified body certification, which is particularly acute for small and medium-sized enterprises (SMEs).
For medical devices, the regulatory environment in the EU is resulting in shortages, thus restricting patient access to innovative and life-saving technologies. The certification by notified bodies and inconsistencies in application of the medical device regulations and guidelines has led to unpredictable timelines and market access. Several previous interventions by the Commission have not improved this situation. Even though the medical devices industry (less so the in vitro diagnostic industry) is used to undertaking clinical evaluations - building out technical files and documentation and establishing and maintaining quality management systems for notified body review - they have found the regulations and implementation so challenging that medical devices are being removed from the market and some innovative products will never make it onto the EU market, or will be substantially delayed in their entry to that market.
The EU Commission, giddy with the success of the GDPR, which has been copied and implemented in many countries, is proud of to be the first region to regulate AI in a comprehensive manner. However, under the AI Act, any products (not just medical devices) falling within the definition of a ‘high-risk AI system’ (HRAIS) will be subject to similar requirements and notified body certification that are causing complexity in the medical device industry. This will be an additional certification for medical devices that are also HRAIS. This must raise the question whether the AI Act, which is of much broader application, will prove to similarly be a constraint on the use and implementation of AI systems in the EU as the MDR and IVDR are for medical devices.
Read our recent article which highlights some of the major differences between the AI Act and the EU medical device regulations. For medical device manufacturers with products to which the AI Act applies, the article also offers food for thought for how to comply with both regimes. You might also have some sympathy for those from other industries who will have to get to grips with the EU's methodology for regulating their HRAIS products given your familiarity with the MDR/IVDR. Even if you already place medical devices certified by a notified body on the market where the AI Act also applies for medical devices categorised as HRAIS, its additional requirements are still going to be hugely challenging.
